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

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Mapping the EU Regulatory Landscape for Personal Protective Equipment in Light of COVID-19 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 1​ ​of 23 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 2​ ​of 23 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, ​surgical 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. ​Following 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 ​Regulation (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’. 3​ ​of 23 Medical devices should be understood in the sense of the ​Medical Device Directive​ (MDD) and ​Medical 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 ​masks 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 ​Interpretative 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. 4​ ​of 23 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 ​Annex 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​ ​of 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​ ​under 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.
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