Mapping the EU Regulatory Landscape for Personal Protective Equipment in Light of COVID-19

Prepared by: Celia Le Lievre Regulatory Compliance Specialist, Compliance & Risks

May 2020

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Introduction 3 1. Personal Protective Equipment Versus Medical Devices 3 2. Classification and Conformity Assessment Procedures for PPE 5 3. Changes Brought By the New Medical Device Regulation 8 4. Harmonized Standards (EN Standards) 10 5. CE Marking and Labeling of PPE 13 6. Import / Export of PPE During COVID-19 14 7. Importers of Personal Protective Equipment 16 8. Regulation on Hazardous Substances 17 9. Conclusion 19 10. Useful References 21 About the Author 22 About Compliance & Risks 23

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Introduction

On 11 March 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic. The rapid spread of the disease has placed an unprecedented strain on the global demand for personal protective equipment (PPE) such as protective gloves, s​ urgical masks, FFP-type masks, protective glasses, face shields and gowns. Amid ​ this concern, the European Union (EU) ​ ​has enacted emergency measures and reinforced its arsenal of guidance documents to address shortages and increase the availability of PPE and medical devices on the EU market. F​ ollowing this momentum in the fight against COVID-19, extraordinary measures have been taken to restrict exportation of certain PPE and remove regulatory barriers by simplifying certification and market surveillance procedures.​ The EU Commission is also continuously working on developing new guidance to assist prospective manufacturers of PPE.

Since the onset of the COVID-19 outbreak, many companies have converted their production sites to meet the global demand for PPE. It is therefore critical for manufacturers and importers to have a clear understanding of applicable product regulations, standards and inherent obligations therein.

This white paper provides an overview of the legal framework and discusses key regulatory developments with a bearing on safety requirements, testing, certification and labeling of PPE.

1. Personal Protective Equipment Versus Medical Devices

Personal protective equipment (PPE) is defined under Article 3 of R​ egulation (EU) 2016/425 as any equipment designed to be worn or held by an individual for protection against one or more health and safety risks, including inhalation of hazardous substances and exposure to harmful biological agents. PPE also refers to interchangeable components which are essential to ensure the protective function of the equipment and any connection systems that are not held or worn by a person but designed to connect the equipment to an external device or ‘reliable anchorage point’.

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Medical devices should be understood in the sense of the ​Medical Device Directive​ (MDD) and M​ edical Device Regulation ​ (MDR) as any instrument, apparatus, appliance, material and other article intended to be used in a medical setting for diagnostic, prognostic, examination and therapeutic purposes.

As a general rule, special account shall be taken of the principal intended purpose of the medical device or PPE to determine whether a product falls within the scope of the PPE Regulation or MDD/MDR.

Where a product is mainly intended to protect the health and safety of the person using it, the equipment will fall within the scope of the PPE Regulation. As such, disposable and reusable face masks, Filtering Facepiece-type masks (FFP2/FFP3) as well as protective coveralls, face shields, disposable and reusable gloves, goggles and protective glasses ensuring protection of the wearer against particulate hazards or harmful biological agents, are examples of PPE falling within the scope of the PPE Regulation (EU) 2016/425.

Surgical m​ asks and examination gloves, as well as surgical gloves and surgeon/medical gowns intended to be used in a medical context to protect the patient against particles and pathogen transmission, are classified as medical devices. These products are regulated in accordance with the MDD and MDR once the latter becomes applicable​.

In some instances, certain face masks (other than FFP-type masks) and protective gloves may serve a ‘double purpose’ and fall under the scope of both the PPE Regulation and Medical Device Directive. For example, certain protective gloves used for the examination of patients may also serve the protection of the user against exposure to body liquids and infectious agents. As such, these may be considered as both PPE and medical devices. The EU Commission’s I​ nterpretative Document​ helps clarify the interplay between the PPE Regulation and Medical Device Directive. According to the Commission’s Interpretative Guide, where a product is intended to be used as a medical device and as PPE at the same time, it must fulfil the essential requirements of both the MDD/MDR and PPE Regulation. Therefore, certain face masks (other than FFP-type masks) and examination gloves which are designed to protect the patient and the wearer must meet the requirements of both legislations. Conversely, medical or surgical masks should be considered as medical devices if their intended purpose is to protect the third-party (patient) in the medical environment.

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It is the responsibility of the manufacturer to determine, on a case-by-case basis, which health and safety requirements and conformity assessment procedures apply taking into account the classification and intended purpose of a specific product.

2. Classification and Conformity Assessment Procedures for PPE

Prior to placing PPE products on the market, manufacturers shall ensure that PPE are designed and manufactured in accordance with the essential health and safety requirements set out in A​ nnex II of Regulation 2016/425​. Annex I of the ​Medical Device Directive 93/42/EEC​ lays down the essential safety and performance requirements for the design, manufacturing and placing on the market of medical devices. Medical/surgical masks and protective gloves intended to protect both the patient and the wearer may also be required to satisfy the safety and performance requirements of Annex I of MDD/MDR. Manufacturers shall ensure that the correct conformity assessment procedure has been carried out or perform a self-certification depending on the classification of the product.

The PPE Regulation establishes distinct conformity assessment procedures depending on the classification and type of PPE. PPE of category III such as FFP masks and other equipment ensuring protection against harmful biological agents are subject to an EU-type examination which requires the mandatory insight of a notified body. The EU-type examination is completed by either internal production controls and supervised product checks (Annex VII) or a conformity to type based on quality assurance of the production process (annex VIII). Periodic controls must be performed by the same notified body to ensure the production remains in conformity with the initial EU-type examination certificate.

In a similar approach, the MDD/MDR classifies medical devices in accordance with a risk-based classification system which determines the level of scrutiny and type of conformity assessment to be applied before placing a product on the market. Equipment with a lower-risk profile such as non-sterile surgical masks and examination gloves fall in the category of Class I medical devices and as such, these may be subject to a self-certification procedure by the manufacturer. On the other hand, Class II and III medical devices with higher perceived risks require the scrutiny of a notified certification body. Medium risk

5​ o​ f 23 medical devices (Class IIa) generally include surgical gloves as well as surgical masks and examination gloves supplied in sterile condition.

The EU Commission issued ​useful guidance​ u​ nder the MDD to help manufacturers navigate the classification system. Classification criteria consider aspects such as the degree of invasiveness (i.e. the extent to which a device penetrates the human body), the duration of contact with the patient, and characteristics of the device (sterile or non-sterile, measurement function and incorporation of software).

Under normal circumstances, manufacturers of Class I medical devices (i.e. non sterile surgical masks, examination gloves) may self-certify compliance of their products with the essential requirements of the MDD/MDR. To do so, manufacturers shall follow the procedure of Annex VII of the MDD, draw up the EU declaration of conformity and affix the CE marking. Stated differently, these products ​do not require an independent conformity assessment to be carried out (and EU-type certificate to be issued) by a notified body.

Surgical gloves, surgical masks and examination gloves sold in sterile condition are classified under a higher risk category (Class II) and require the oversight of a notified body. In the context of surgical masks and examination gloves supplied in sterile condition, the notified body assessment should be limited to the manufacturing aspects which are concerned with ‘securing and maintaining’ sterile conditions. The notified body carries out the specified tests and draws up an EC certificate to this effect.

Once compliance has been demonstrated, manufacturers shall then draw up the technical documentation, prepare the EU declaration of conformity and affix the CE marking to the PPE. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market. Additionally, manufacturers shall have procedures in place to ensure the series production remains in conformity with the PPE Regulation and MDD/MDR.

Where a PPE is subject to both the requirements of the PPE Regulation and the MDD/MDR, a single EU declaration of conformity may be established with respect to both legislations. ​The declaration of conformity shall include the following information elements: ● PPE (product, type, batch or serial number)

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● Name and address of the manufacturer ● Statement that ​the declaration of conformity has been issued under the sole responsibility of the manufacturer ● Object of the declaration (identification of PPE allowing traceability; where necessary for the identification of the PPE, a colour image of sufficient clarity may be included) ● Statement that the PPE is in conformity with the relevant Union harmonization legislation ● References to the harmonized standards used including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared ● Where applicable, the name and identification number of the notified body involved in the conformity assessment procedure ● The type of conformity assessment procedure (either conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) or conformity to type based on quality assurance of the production process (Module D))

The content of technical documentation is specified in Annex III of the PPE Regulation and Annex VII of the Medical Device Directive. In essence, technical files resemble product specification sheets. Technical files shall include the following elements: ● Complete description of the PPE ● Design and manufacturing drawings ● The results of a risk analysis enabling to identify the risks against which the PPE is intended to protect ● List of applied harmonized standards, directives and essential requirements ● Design calculations, inspections and examinations carried out to verify conformity ● Labels and instructions for use

In the context of the COVID-19 threat,​ the European Commission has temporarily relaxed conformity assessment rules and market surveillance procedures for PPE. ​In Recommendation 2020/403,​ the EU Commission has a​ uthorized the placing on the market of PPE for which a formal conformity assessment procedure, including the affixing of the CE marking, has not yet been finalized. This measure applies to PPE intended to be used by healthcare workers exclusively. Although not legally binding, the Commission’s

7​ o​ f 23 recommendations encourage notified bodies to prioritize new requests for PPE deemed necessary to reverse the pandemic. Per the Commission’s recommendation, market surveillance authorities may only authorize PPE that ensures an adequate level of health and safety in accordance with the essential requirements laid down for that product. If not yet finalized, PPE shall nonetheless be in the process of a certification procedure. To this effect, market surveillance authorities may require a copy of test reports and confirmation by the manufacturer that the product is in the process of being certified.

In exceptional circumstances, non-CE marked PPE for which a conformity assessment procedure has not been initiated may be placed on the market if the product is part of a purchase organized by a Member State and if the following (cumulative) conditions are satisfied: ● The product is manufactured in accordance with harmonized standards or in line with the standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety ● The product is only made available to healthcare workers for the duration of the current health crisis ● The product is not entering the regular distribution channels and made available to other users

PPE produced for supply through the government during COVID-19 would therefore not be subject to the assessment of a notified body. The Commission has developed ​guidance ​ in this respect to help prospective manufacturers identify the legal framework and c​ ertification procedures​ applicable to the production and marketing of PPE.

3. Changes Brought By the New Medical Device Regulation

As of 26 May 2021, the Medical Device Directive 93/42/EEC will be repealed by ​Regulation (EU) 2017/745.​ The new Regulation entered into force on 25 May 2017 and was initially scheduled to replace the MDR on 26 May 2020. I​ n light of the COVID-19 outbreak​, t​ h​e Council and the European Parliament agreed to postpone the date of application by one

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1 year​ (from 26 May 2020 ​ to​ ​26 May 2021​). The deferral of application date means that the requirements of the MDD remain applicable throughout the entire duration of the health emergency crisis.

The MDR establishes a complex regulatory system with a series of new classification criteria and traceability rules alongside reinforced obligations on manufacturers. Medical devices are categorized based on 22 classification rules (Chapter III, Annex VIII) which, to a large extent, reflect the criteria of the MDD and incorporate the following elements: ● Type and degree of invasiveness with respect to body orifices ● Duration and location of contact with the patient and part of the body affected ● Characteristics of the device (sterile, non-sterile, active vs. non active, single-use or reusable, combined use with other medicinal substances)

Manufacturers shall carefully consider the criteria of Annex VIII to establish the classification of their products and the corresponding conformity assessment procedure. Non-sterile surgical masks, examination gloves (other than surgical gloves) and medical gowns may be considered as Class I medical devices unless other specific criteria of Annex VIII apply.

Class I medical devices shall be in conformity with the MDR from ​26 May 2021.​ As such, compliance and MDR certification must be sought from ​26 May 2021.​ Higher class devices such as sterile surgical masks and surgical gloves requiring the intervention of a notified body may be placed on the market until the expiry date of EC-type certificates.

Annex I of the MDR retains the safety and performance requirements of Annex I of the MDD. Similar to the MDD, the conformity assessment of Class I medical devices must be carried out under the sole responsibility of manufacturers. Legal ma​ nufactures ​shall declare the conformity of their products after conducting the specified tests and issuing the EU declaration of conformity and technical documentation as set out in Annexes II and III. The

1 Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending ​ Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions

9​ ​of 23 declaration of conformity shall be drawn up in accordance with Article 19 and the CE label shall be affixed to the device or its packaging (Article 20).

The MDR introduces new technical documentation and reporting obligations for manufacturers. A key feature of this Regulation is the requirement for clinical evaluations and post-market surveillance which should be part of a more comprehensive quality and risk management system implemented by the manufacturer (Article 10 (2) and (9)). As of 2​ 6 May 2021,​ manufacturers, including of Class I medical devices, shall have a quality and post-market surveillance system (PMS) in place for each device made available on the market. The PMS should be proportionate to the risk profile of the product and consists of systematic procedures for collecting and analyzing data to check the performance and safety of the device concerned. Annex III specifies the type of technical documentation on PMS to be drawn up by the manufacturer. For Class I medical devices, technical documentation on market surveillance primarily consists of a PMS plan and PMS report summarizing the results and conclusions of post-market surveillance data (Articles 84 and 85). These documents are therefore distinct from and must be prepared in addition to the technical files specified in Annex II.

Further commitments are defined to designate at least one person responsible for regulatory compliance activities (Article 15). Additionally, new labeling requirements will apply to enhance the identification and traceability of medical devices. As of 2​ 6 May 2025,​ Class I medical devices (i.e. surgical masks and examination gloves in non-sterile conditions) shall bear a Unique Device Identification (UDI) which must be affixed to the label of the device and all higher levels of packaging including shipping containers. Class IIa medical devices, such as surgical gloves and, or surgical masks and examination gloves sold in sterile conditions, shall bear a UDI from​ 26 May 2023 (​ Article 123 (f)). The Identification Code shall be referenced in the declaration of conformity and entered into the European Database (EUDAMED).

4. Harmonized Standards (EN Standards)

Both the MD/MDR and PPE Regulation are presented as ‘technologically neutral’. These two legislations intend to establish a legal framework and do not prescribe technical solutions

10​ o​ f 23 for the design of PPE. Technical solutions are specified in harmonized standards. The EU Commission has reached decisions on harmonized standards for PPE. Compliance with harmonized standards confers presumption of conformity with legislative requirements and facilitates unhindered market access for PPE products that ensure a high degree of safety.

Decision (EU) 2020/437​ on the harmonized standards for medical devices drafted in support of the MDD provides a complete list of references of harmonized standards for critical medical devices such as medical face masks (EN 14683:2019), surgical masks (EN 14683:2005), surgical drapes and gowns (EN 13795:2019) and medical gloves (E​ N 455-1:2000, EN 455-2:2009+A2:2013, EN 455-4:2009).

Compliance with essential health and safety requirements may also be demonstrated if PPE are manufactured in accordance with the standards referenced in the W​ HO guidelines​ or other technical solutions that meet EU health and safety requirements. While manufacturers may use alternative technical solutions, compliance with the specifications laid down in EU harmonized standards facilitate a ‘swifter’ placing on the market.

To match the increasing demand for PPE during the COVID-19 outbreak, the European Commission together with ​the European ​ ​Committee for Standardization ​ (​ CEN) and CENELEC have​ ​agreed to make freely available a series of 14 E​ uropean standards​ for medical devices and PPE. These standards are freely accessible on the o​ nline catalogues​ of national standardization bodies.

Harmonized standards contain minimum requirements and testing procedures to establish compliance with relevant EU legislation. As discussed above, Filtering Facepiece masks (FFP-type masks) fall in the category of PPE. Manufacturers and importers shall ensure that FFP masks have been verified and obtain a test report and EU-type certificate from a notified body. For surgical/medical masks classified as Class I medical devices, compliance must be assessed by the manufacturer pursuant to the tests prescribed in the applicable Standard.​

The respective harmonized standards are ​EN 149:2001+A1:2009 ​ for FFP masks and E​ N 14683:2019/EN 14683:2005 ​for medical and surgical masks.

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Standard EN 149:2001 ​establishes minimum requirements for Filtering Facepiece masks which are intended to protect the wearer from both inhalations of droplets and airborne particles which may contain infectious agents. FFP masks are categorized based on their filter capacity: ● FFP1: filtering at least 80% of aerosols (total leakage inside <22%) ● FFP2: filtering at least 94% of aerosols (total leakage inside <8%) ● FFP3: filtering at least 99% of aerosols (total inward leakage <2%)

Laboratory tests and performance requirements may vary depending on the above categories of FFP-type masks.

Standard EN 14683 ​ defines the performance requirements and test protocols to be applied to surgical/medical masks intended to limit the transmission of infectious agents to patients. The tests typically range from visual inspections to assessment of bacterial filtration, quality control of elastic bands, breathability, resistance to projections and microbial cleanliness tests. ​The test protocols may be performed either by the manufacturer or a notified laboratory acting on his behalf. Where surgical/medical masks and gloves are sterile, tests must be carried out by a notified body with respect to sterility aspects.

Where manufacturers decide to rely exclusively on the standards referred to under the WHO guidelines or other technical solutions, a sample of PPE shall be presented to a notified testing body. The PPE Regulation allows for a single sample of manufactured PPE to be tested. The sampling procedure aims at ensuring the homogeneity of production. Ongoing product checks shall be carried out at least one a year at random intervals. Where the manufacturer opts for an EU-type examination​ based on quality assurance procedure, the notified body shall carry out periodic audits, at least once a year, to ensure that the manufacturer maintains his quality system and delivers audit reports.

Other harmonized standards for protective clothing, medical gloves and eye-protection equipment include: ● EN 166:2001 Personal eye-protection – Specifications ● EN 14126:2003 + AC 2004 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

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● EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD) ● EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD) ● EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD) ● EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)

The manufacturer shall keep the EU-type certificate, test report or audit report at the disposal of national authorities for at least 10 years after placing the PPE or medical device on the market. When deemed appropriate, manufacturers shall also carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

5. CE Marking and Labeling of PPE

Once compliance has been demonstrated by means of the conformity assessment procedure, the manufacturer shall affix the CE marking. Where ​ the oversight of a notified body is required to perform laboratory testing, the identification number of the notified body should also appear below the CE marking.

The CE marking may only be affixed if a sample of PPE has been tested and approved by the competent notified body. When PPE is subject to the requirements of both the PPE Regulation and MDD/MDR, the manufacturer can affix a single CE mark to show compliance with both legislations.

PPE shall bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the PPE does not allow it, this information must appear on the packaging or in a document accompanying the PPE.

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The manufacturer shall clearly indicate, on the PPE, their name, registered trade name or registered trade mark and a single postal address at which they can be contacted. Alternatively, this information may be provided on the packaging or in a document accompanying the PPE.

Certain protective garments may be treated as textile products if they contain at least 80% by weight of textile fibre. In this respect, R​ egulation (EU) 1007/2011​ r​ equires that textile products placed on the market be labeled with information on their fibre composition and accompanied with commercial documentation. Only textile fibre names listed in Annex I shall be used for the description of fibre composition on labels and markings.

6. Import / Export of PPE During COVID-19

The EU Commission has imposed restrictions on the exportation of certain PPE regardless as to whether PPE are originating in the EU.

On 15 March 2020, the EU Commission adopted Implementing R​ egulation (EU) 2020/402 making the exportation of certain PPE outside the EU subject to a prior authorization. T​ hat Regulation was revised by Regulation (EU) 2020/426 and subsequently replaced by Regulation (EU) 2020/568​ of 23 April 2020. ​ ​Regulation 2020/568 has reduced the list of PPE subject to an export authorization to three categories of products. The products in scope are those specifically listed with a CN Code in Annex I: ● Protective spectacles and visors​ covered by C​ N Code ex 9004 90 10 and ex 9004 90 90 meeting the following description: protection against potentially infectious material; encircling the eyes and surroundings; compatible with different models of FFP masks and facial masks; transparent lens; reusable (can be cleaned and disinfected) or single-use items ● Mouth and nasal protection equipment ​ (CN Codes: ex 6307 90 98 and ex 9020 00 00). This category encompasses Filtering Facepiece masks classified under FFP1, FFP2 and FFP3, and medical/surgical masks ● Protective garments​ (CN Code ex 3926 20 00, ex 4015 90 00, ex 6113 00, ex 6114, ex 6210 10 10, ex 6210 10 92, ex 6210 10 98, ex 6210 20 00, ex 6210 30 00, ex 6210 40 00, ex 6210 50 00, ex 6211 32 10, ex 6211 32 90, ex 6211 33 10, ex 6211 33 90, ex

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6211 39 00, ex 6211 42 10, ex 6211 42 90, ex 6211 43 10, ex 6211 43 90, ex 6211 49 00, ex 9020 00 00)

An export authorization must be established in accordance with the form provided in Annex II prior to exporting the above mentioned equipment. Such authorization is limited to Union goods and is not required for non-Union goods. The authorization shall be granted by the designated competent authority of the Member State where the exporter is established. In this regard, the EU Commission has published a ​list of competent authorities in Member States ​ responsible as well as a ‘​Frequently Asked Questions’ document on Export Requirements for Certain PPE.​ Face shields covered by CN Code 3926 90 97 are no longer listed in Annex I and therefore no longer subject to the scheme.

The new Regulation extends the scope of geographical exemptions to EFTA countries including Albania, Andorra, Bosnia and Herzegovina, Faroe Islands, Gibraltar, Iceland, Kosovo, Liechtenstein, Montenegro, Norway, North Macedonia, San Marino, Serbia, Switzerland, Vatican City, Büsingen, Heligoland, Livigno, Ceuta and Melilla and certain overseas territories.

Regulation 2020/568 will remain in force until 2​ 6 May 2020.

On 3 April 2020, the ​Commission decided to approve requests from Member States to waive 2 value added tax and customs duties on the import of PPE from non-EU countries and developed g​ uidance​ to support uniform implementation of the Union Customs Code during the crisis. The relief will remain in place until 31 July 2020 and may be extended if necessary after consultation with Member States.

2 Commission decision on relief from import duties and VAT exemption on importation granted for goods ​ needed to combat the effects of the COVID-19 outbreak during 2020, C(2020) 2146 final.

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7. Importers of Personal Protective Equipment

Importers shall remain vigilant amid recent relaxations of market surveillance rules. ​As an importer of PPE, your role is to ensure that the PPE or medical device complies with the essential EU health and safety requirements.

In particular, importers have the obligation to verify that the correct conformity assessment procedure has been carried out and that the CE marking and technical documentation have been drawn up by the manufacturer. The European Safety Federation stresses the importance of checking the title of the EU conformity certificate, name and registration number of the issuing organization. EU-type certificates shall be titled ‘EU type examination certificate’. They must be issued by a recognized notified body based in the EU or EFTA country. The ​NANDO database ​ of the EU Commission provides insightful information on the competence of notified bodies. In addition, PPE shall be accompanied by instructions for use and the specified information listed in Annex II (point 1.4) of the PPE Regulation. Importers must request and keep a copy of the EU-type examination certificate, test reports, EU declaration of conformity and technical documentation drawn up by the manufacturer.

The importer shall indicate his trade name or registered trade mark as well as his registered place of business and postal address on the PPE or on its packaging or accompanying document. The importer shall ensure that any additional label does not obscure the labeling information of the manufacturer.

Perhaps most importantly, the importer shall refrain from placing PPE/medical devices on the market if he considers that the PPE or medical device is no longer compliant and takes corrective actions to bring the product into conformity with the requirements of the PPE Regulation or MDD/MDR. In this respect, the importer is required to keep a register of complaints and of non-conforming devices, recalls and withdrawals and forward this information to manufacturer and distributor.

In some circumstances, the importer of PPE will be considered as the manufacturer and be subject to the same obligations. This will be the case where the product is placed on the market under his own name or trademark or when the importer changes the intended

16​ ​of 23 purpose of the PPE or even modifies the product in such a way that compliance with the PPE Regulation or MDD may be affected. As such, the importer will be required to carry out the applicable conformity assessment procedure and to obtain an EU-type certificate from a notified body. The importer will additionally be required to draw up the specified technical files and EU declaration of conformity to show compliance with EU requirements and affix the CE marking accordingly.

8. Regulation on Hazardous Substances

In addition to the requirements for certification, PPE and medical devices shall comply with Regulation (EU) 1907/2006​ concerning the Registration, Evaluation, Authorisation and Restriction of certain Chemicals (REACH). REACH is implicitly referred to under the requirement concerning the ‘innocuousness of PPE’ in Annex II of the PPE Regulation. ‘Chemical innocuousness’ should be understood as meaning that PPE, including their constituent materials, shall not create additional risks or nuisance factors under foreseeable conditions of use. In a similar language, Annex I of the MDD provides that medical devices shall be manufactured in such a way as to minimize exposure to contaminants and hazardous substances and more specifically, substances which are carcinogenic, mutagenic and toxic to reproduction (CMR).

Pursuant to the REACH principle ‘no data, no market’, it is prohibited to place on the market a substance which has not been notified/registered within a month following its placement on the EU market. Producers ​ and importers of PPE/medical devices containing hazardous substances, pollutants or heavy metals from outside the EU shall register with the European Chemicals Agency (ECHA) where the following conditions are met: a) The substance is manufactured or imported in quantities totalling over 1 tonne per year and b) The substance is intended to be released under normal or reasonably foreseeable conditions of use

For Substances of Very High Concern (SVHC) - listed under Annex XIV of REACH – such registration/notification shall take place where:

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a) The substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year and b) The substance is present in the article in a concentration greater than 0.1% weight by weight (w/w)

Substances fulfilling one or more criteria of Article 57 of REACH can be identified as Substances of Very High Concern (SVHC). These substances are listed in Annex XIV of REACH and cannot be placed on the market unless they have been duly authorized by ECHA in accordance with Article 60 to 64 of REACH.

The information to be submitted in the registration dossier shall include i​ nter alia:​ ● The identity and contact details of the producer or importer ● The identification/registration number assigned by the Agency at the time of registration ● The identity and classification of the substance contained in the PPE/medical device ● Description of the use of the substance in the article ● The tonnage range of the substance, i.e. 1 to 10 tonnes, 10 to 100 tonnes and so on

Annex XVII contains the list of restrictions for certain dangerous substances (or preparations) placed on the market and used in the manufacture of articles. Specific limits apply to Lead (entry 63), Cadmium (entry 23), Formaldehyde (entry 72), Nickel (entry 27), Chromium IV (entry 47), Phthalate (entry 51) and Polycyclic Aromatic Hydrocarbons (PAHs) (entry 50) likely to be found in ‘plasticised materials’ including latex and rubber. Restrictions also apply to solvent Dimethylformamide (entry 30), commonly used in the coating of protective gloves, and to azocolourants and azodyes releasing aromatic amines in detectable concentrations in protective garments (entry 43).

Manufacturers and importers of PPE/medical devices shall ensure that the product does not contain any regulated substances above the applicable legal limit. Chemical thresholds and testing methods may already be specified under existing harmonized standards. For example, harmonized EN 420 and EN 453 prescribe the maximum pH levels and thresholds of Chromium (IV) content and allergenic proteins that shall not be exceeded in protective gloves. Additional chemical testing may be required as part of the EU-type examination to

18​ o​ f 23 ensure compliance with the restriction limits of Annex XVII of the REACH Chemical Regulation.

Unlike medical devices falling in the scope of the MDD, PPE is not excluded from the B​ iocidal 3 Products Regulation ​ (BPR). The BPR will come into play if FFP-type masks or other types of PPE are treated with biocidal products to supply antiviral and antibacterial properties. The BPR applies to ​treated articles ​ in the same way as biocidal products. Biocidal products in treated articles shall contain only approved active substances for the relevant product-type specified in Annex V. The EU Commission maintains a ​list of approved substances ​ on its website. Applications for approval can be submitted and delivered at the EU level by the European Chemicals Agency or at the national level by a designated competent authority. In addition, treated articles shall be labeled if a claim is made by the manufacturer regarding the biocidal properties (antibacterial or antiviral) of the article. The label shall provide the information specified under Article 58 (3) of BPR including i​ nter alia​, a statement that the treated article incorporates biocidal product(s), the biocidal properties of the article, the name of all substances contained in the biocidal product(s) and relevant instructions for use. In some instances, treated articles with a primary biocidal function may be considered as biocidal products and as such, require an EU or national authorization. The European Chemicals Agency has established a ​briefing paper ​ and more detailed ​guidance ​ to help manufacturers of treated articles understand their obligations under the Biocidal Products Regulation.

9. Conclusion

The salient shortage of PPE and medical devices as a result of COVID-19 does not change the fact that EU health and safety legislation continue to apply albeit with certain relaxations. Businesses seeking to diversify their operations to manufacture PPE and medical devices shall have a clear understanding of the applicable legislation and apply the correct conformity assessment procedure based on the classification of their products. From the early stage of the production, the central question to consider is whether the supplied

3 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 ​ concerning the making available on the market and use of biocidal products.

19​ ​of 23 equipment shall be classified as PPE or medical devices or both under the PPE Regulation or Medical Device Directive.

While certain surgical/medical masks and examination gloves are generally considered as low risk medical devices and therefore subject to a regime of self-certification, other equipment such as sterile masks and surgical gloves will require a type examination to be carried out by a notified body. Stringent EU-type examination and follow-up production controls by a notified body also apply to PPE such as protective masks (type FFP2 or FFP3), protective glasses, face shields and other protective equipment ensuring protection against infectious biological agents such as coronavirus.

Temporary deviations from conformity assessment rules have been granted by the EU Commission to facilitate swift market access for PPE and medical devices which have not yet been fully certified. Such a relaxation is however conditional upon PPE/medical devices being exclusively destined to the healthcare market for the duration of the crisis. Eligible PPE and medical devices shall also ensure an adequate level of health and safety in accordance with the essential requirements of the PPE Regulation and MDD. Likewise, expedited conformity assessment procedures in no way preclude the application of other relevant legislation on biocides and chemicals such as the BPR and REACH Regulation.

Going forward it is likely that the EU will sustain its regulatory momentum to address ongoing shortages of PPE if the pandemic continues to expand. Across the Atlantic Ocean, the sourcing of PPE is also being hampered by the emergence of a so-called ‘wild west’ market for PPE. The United States faces similar shortages resulting in the US Food and Drug Administration (FDA) issuing Emergency Use Authorizations to increase the availability of certain PPE needed to curb the pandemic.

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10. Useful References

Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonized standards for medical devices drafted in support of Council Directive 93/42/EEC https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020D0437&from=EN

Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020H0403&from=EN

Consolidate Directive 93/42/EEC concerning medical devices https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01993L0042-20071011

European Chemicals Agency - what you need to know about treated articles https://echa.europa.eu/documents/10162/26065889/treated_articles_inbrief_en.pdf/1b182 f63-0f46-fa04-eaf4-7937c9da2fbc

European Chemicals Agency - treated articles guidance https://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp

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Export Authorization Scheme of Personal Protective Equipment – List of Competent Authorities in Member States https://trade.ec.europa.eu/doclib/docs/2020/march/tradoc_158674.pdf

Export Requirements for certain Personal Protective Equipment https://trade.ec.europa.eu/doclib/docs/2020/april/tradoc_158693.pdf

European Commission Q&A on Conformity Assessment Procedures for Protective Equipment https://ec.europa.eu/docsroom/documents/40521

European Commission Q&A on 3D Printing & 3D Printed Products used in the Medical Context for COVID-19 https://ec.europa.eu/docsroom/documents/40522

European Safety Federation - Suspicious Certificates for PPE https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe

Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 ​ quarantine orders and travel restrictions https://ec.europa.eu/docsroom/documents/40705?locale=en

Guidance on Customs issues related to COVID-19 emergency https://ec.europa.eu/taxation_customs/covid-19-taxud-response/guidance-customs-issues- related-covid-19-emergency_en

About the Author

Celia Le Lievre RegulatoryCompliance Specialist, Compliance & Risks

Celia is a Regulatory Compliance Specialist with Compliance & Risks. She has a Masters Degree in Maritime Law, a LLM in International Commercial Law and a PhD in the field of renewable energy and environmental protection.

Celia joined Compliance & Risks in January 2020. Her role is focused on conducting extensive legal research and monitoring global regulatory developments impacting the textile and fashion industry. She recently took over the role of Subject Matter Expert for COVID-19, providing clients with regulatory updates and practical insights on their compliance obligations during the state of health emergency.

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About Compliance & Risks

Compliance & Risks helps manufacturers, retailers and their supply chain partners monitor and manage requirements, regulations and standards for a cleaner, safer and better world. It creates business advantage for clients by providing reliable legislative information, insights and actions through C2P, its knowledge management platform, consulting, market access, managed services and other solutions.

The company is recognized as the end to end global regulatory solutions provider across the technology, consumer goods and retail, industrial goods and life sciences sectors. Headquartered in Cork, they also have offices in Brussels, California, London and New York. For more information, please visit w​ ww.complianceandrisks.com

Important Notice: All information provided by Compliance & Risks Limited and its contributing researchers in this report is provided for strategic and informational purposes only and should not be construed as company specific legal compliance advice or counsel. Compliance & Risks Limited makes no representation whatsoever about the suitability of the information and services contained herein for resolving any question of law. Compliance & Risks Limited does not provide any legal services. © 2020 Compliance & Risks Limited. All rights reserved

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