Medicinal Products and Medical Devices in Clinical Trials Conduct and Disclosure

Medicinal products and medical devices in clinical trials condduct and disclosure – and ndever the twain shall meet!

Raquel Billiones 1 and Kathy B. Thomas 2 Despite some fundamental differences, 1 Takeda Pharmaceuticals, Zurich, Abstract similarities and overlaps in the requirements Switzerland “Medicinal products and medical devices are and details between the CTR and MDR are 2 Medical & Scientific Writing & Publication different species…they live in parallel evident. There is also a clear aim for the Services, Meersburg, Germany universes” according to a medical device electronic databases, as described in the two expert. But is it really so? This article regulations, to be interoperable. This high - challenges that notion by comparing the level comparison of the CTR and MDR Correspondence to: Clinical Trial Regulation EU No. 536/2014 shows that while the requirements of the two Raquel Billiones (CTR) and the EU Medical Device regulations have been aligned and are very [email protected] Regulation 2017/745 (MDR) in the context similar, their impact on the respective of clinical studies and public disclosure. industries is quite different.

Two parallel universes years, we already switch between these universes pharmaceutical industry. The major changes “WARNING : Medicinal products and medical and firmly believe that linking these two is not were the centralised clinical trial application, the devices are diﬀerent species. They live in parallel only feasible but also profitable, as other increased disclosure requirements, and the universes. They may appear similar (“medicinal colleagues can also attest. 2 Nevertheless, the setting up of a new EU portal and database (to products”), but they are not. Carelessly switching school of thought that “a drug is a drug, replace the existing ones). between universes may be deadly .” These a device is a device, and never the twain shall In 2017, the EU Medical Device Regulation words are taken from a presentation by Ronald meet” is relatively widespread. 3 2017/74 5 (henceforth referred to as MDR) was Boumans, a Senior Regulatory Consultant at released. Literally “left to its own devices till Emergo Group. 1 Jokes aside, after evaluating the Two universes, two regulations now”, 3 the medical technology industry struggles two regulations, we are compelled to challenge In 2014, the Clinical Trial Regulation European with the drastically increased and unfamiliar this statement. As professional regulatory Union (EU) No. 536/2014 4 (henceforth regulatory requirements of this legislation. 6,7 medical writers who have been developing referred to as CTR) was released. The detailed Following the thread of Bouman’s analogy, it felt regulatory documents for both pharmaceutical requirements and documentations of this like aliens had invaded the medical device drug products and medical devices for many legislation were really nothing new for the universe.

74 | June 2019 Medical Writing | Volume 28 Number 2 Billiones and Thomas – Medicinal products and medical devices in clinical trials conduct and disclosure

As professionals working for the two transparent, predictable, and sustainable regu - needed for approval of a new device than for a industries, we were obliged to familiarise latory framework for medical devices which new medicinal product. 3 ourselves with these two new legislations. This ensures a high level of safety and health whilst article makes a high-level comparison between supporting innovation [and] to ensure the Clinical study registration the CTR and the MDR (Table 1) based on the smooth functioning of the internal market as Both CTR and MDR require registration of original texts of the legislations and the authors’ regards medical devices . . .” 5 clinical studies in a publicly accessible registry. interpretation of those texts built on their The other important difference is that under Each study must be identified with a unique ID experiences of working in the pharma and the CTR, the EMA (“the Agency”) has the major number. This requirement was already covered in medical device industry. The comparison is responsibility of implementation, with support the previous legislation for medicinal products focused on the conduct and disclosure of clinical from the European Commission (EC) and the but not in the predecessors of the MDR. studies, often referred to as clinical trials for member states. For the MDR, the major In the USA, the database ClinicalTrials.gov medicinal products and as clinical investigations responsibility of the implementation lies with the provides a clear breakdown of clinical trials by for medical devices. EC, working together with the competent drugs, biologics, surgical procedures, and devices. authorities of the EU member states. To date, this kind of breakdown of clinical studies Obvious differences is not readily available for studies performed in The most obvious difference is the scope of the Similarities and overlaps the EU or the states of the EEA in the current two regulations. The CTR, as its name implies, The MDR and CTR were written three years database, the EU Clinical Trials (CT) Register. covers interventional clinical trials for medicinal apart and our initial reaction when we first read Currently, the EU CT Register requires only products and supersedes Directive 2001/20/EC the MDR was that the two universes are coming registration of medicinal products tested in and Paediatric Regulation (EC) No. 1901/2006. together, especially when it comes to clinical interventional clinical trials with at least one trial The purpose of the CTR is to add clarity to the study conduct, reporting, and disclosure, as site in the EU/EEA and “does not provide previous laws as well as simplify and harmonise summarised below and also in Table 1 (that information on clinical trials for surgical the administrative processes for clinical trials compares the CTR and MDR). procedures, medical devices, or psycho - performed in the EU/European Economic Area therapeutic procedures”. The MDR may resolve (EEA). Other regulatory aspects of CTR, such Clinical study conduct this information gap, as discussed in the as market authorisation and pharmacovigilance, Clinical evidence is needed for new health following sections. are covered by the Directive 2001/83/EC and products to be granted market access. Clinical Regulation 726/2004. studies (trials or investigations) are performed to The electronic systems and databases The MDR, on the other hand, has a much collect data on efficacy and safety of the tested To support the CTR harmonised approach to broader scope than the CTR and goes beyond products. The CTR and MDR are relatively submission, assessment, and reporting of clinical clinical investigations by including manu - aligned in their definitions of clinical trials and trials, the EC has mandated the EMA to establish facturing, market access, and post-market investigations, respectively, as well as in respect a new EU portal and database according to the vigilance. MDR supersedes two Directives, of the key involved stakeholders (Table 1). specifications in the CTR. Data submitted 90/385/EEC (active implantable devices, 2007) In some cases, the terminologies used differ through the new portal will be stored in an EU and 93/42/EEC (other devices, 2007). The main slightly while the definitions are almost identical. database that is open to the public. Duplications objectives of the MDR are “to establish a robust, In general, it seems that fewer clinical studies are with the existing databases (Eudravigilance and

www.emwa.org Volume 28 Number 2 | Medical Writing June 2019 | 75 Medicinal products and medical devices in clinical trials conduct and disclosure – Billiones and Thomas

Table 1. Comparison of the requirements for clinical trials/investigations conduct and disclosure under the CTR 536/2014 and MDR 2017/745 EU CTR 536/2014 EU MDR 2017/745

Full name Regulation (EU) No 536/2014 of the European Regulation (EU) 2017/745 of the European Parliament and of the Council Parliament and of the Council of 16 April 2014 on clinical of 5 April 2017 on medical devices, amending Directive 2001/83/EC, trials on medicinal products for human use, and repealing Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Directive 2001/20/EC repealing Council Directives 90/385/EEC and 93/42/EEC

Scope Clinical studies in medicinal products: Clinical studies in medical devices: submission, assessment, submission, assessment, notification, disclosure notification, disclosure (Article 62, Annex XV) Manufacturing, CE-marking (market authorisation), post-market surveillance of medical devices

Definitions of Clinical study a: any investigation in relation to humans Clinical investigation : any systematic investigation involving one or terms related to [intended to study clinical, pharmacological, pharma - more human subjects, undertaken to assess the safety or performance clinical studies codynamic eﬀects, identify any adverse reactions, study of a device (per CTR or MDR) absorption, distribution, metabolism and excretion] … with the objective of ascertaining the safety and/or eﬃcacy of those medicinal products

Investigational medicinal product : a pharmaceutical Investigational device : a device that is assessed in a clinical form of a medicinal product which is being tested or used investigation as a reference, including as a placebo, in a clinical trial

Protocol : a document that describes the objectives, Clinical investigation plan : a document that describes the rationale, design, methodology, statistical considerations and objectives, design, methodology, monitoring, statistical organisation of a clinical trial considerations, organisation and conduct of a clinical investigation

Sponsor : an individual, company, institution or organisation Sponsor : any individual, company, institution or organisation which which takes responsibility for the initiation, for the manage - takes responsibility for the initiation, for the management and setting ment and for setting up the financing of the clinical trial up of the financing of the clinical investigation

Subject : an individual who participates in a clinical trial, Subject : an individual who participates in a clinical investigation either as recipient of an investigational medicinal product or as a control

Investigator : an individual responsible for the conduct of Investigator : an individual responsible for the conduct of a clinical a clinical trial at a clinical trial site investigation at a clinical investigation site

Informed consent : a subject's free and voluntary expression Informed consent : a subject’s free and voluntary expression of his or of his or her willingness to participate in a particular clinical her willingness to participate in a particular clinical investigation, after trial, after having been informed of all aspects of the clinical having been informed of all aspects of the clinical investigation that are trial that are relevant to the subject's decision to participate, relevant to the subject's decision to participate or, in the case of minors or in case of minors and of incapacitated subjects, an and of incapacitated subjects, an authorisation or agreement from their authorisation or agreement from their legally designated legally designated representative to include them in the clinical representative to include them in the clinical trial investigation

Clinical trial / l Required for all investigational medicinal products l Required for certain device classes (Class II to III) that do not have investigation conduct a CE mark

Clinical trial / l Obligatory for all studies with at least 1 EU site, l Obligatory for all investigations with at least 1 EU site, submitted investigation submitted via EU portal, stored in the EU database on the electronic system for clinical investigations within the registration l Unique EU trial number (Article 81) Eudamed (Article 73) l Unique ID number for each investigation (Article 62) l If the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the oﬃcial registration number of the clinical trial (Annex XV, Chapter II)

Continued opposite

76 | June 2019 Medical Writing | Volume 28 Number 2 Billiones and Thomas – Medicinal products and medical devices in clinical trials conduct and disclosure

EU CTR 536/2014 EU MDR 2017/745

Databases l EU portal as a single entry point for the submission of data l Eudamed that integrates several electronic systems and information relating to clinical trials (Article 80) (Article 33) l Data and information submitted through the EU portal l The electronic system for clinical investigation is the entry shall be stored in the EU database (Article 81) point for the submission of all applications or notifications l Unnecessary duplication between database and EudraCT for clinical investigations (Articles 70, 74, 75, 78); for all and EudraVigilance databases to be avoided other submission of data, or processing of data l Partial public access l Partial public access, all public parts should be user-friendly l European Medicines Agency as controller and in an easily searchable format l European Commission is the controller l To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use (Preamble 67)

Public disclosure: l Protocol, IB, IMPD (S and E), SmPC (Annex I) l Clinical investigation application dossier Clinical study l Protocol to describe publication policy (Annex I, D 17-ai) (Article 62; Article XV) application Potentially all publicly accessible l Clinical Investigation Plan (CIP), IB (Annex XV) l CIP to contain policy on the CIR and publication of results (Annex XV, Chapter II, 3.17) l Potentially all publicly accessible

Public disclosure: l Public access via the EU database l Public access via the Eudamed Study results l A summary of the results of the clinical trial irrespective of l CIR within one year of the end of the clinical investigation or reporting the outcome, to be submitted within 1 year (Article 37; within 3 months of the early termination or temporary halt, Annex IV) irrespective of the outcome (Article 77) l Layperson’s summary (Article 37; Annex V) l Summary easily understandable by a user (Article 77) l CSR within 30 days post-MAA decision (Article 37) l Publication of results according to legal requirements and ethical principles (Annex XV, Chapter II; see next row)

Other ethical l Declaration of Helsinki 2008 (Preamble 80) l Declaration of Helsinki latest version (Preamble 64) guidances that can l ICH guidelines on Good Clinical Practice (Preamble 43) l ISO14155:2011 (Preamble 64) impact disclosure

Protection of l Personal data protection per Regulation (EC) No 45/2001 l Personal data protection per Regulation (EC) No 45/2001 personal data (now replaced by the General Data Protection Regulation (now replaced by GDPR) (GDPR) 2016/679) l CIP should describe arrangements for compliance; measures l Protocol should describe arrangements for compliance, to ensure confidentiality, mitigation measures for security measures to ensure confidentiality, mitigation measures for breach adverse eﬀects (Annex XV Chapter II, 4.5) security breach adverse eﬀects (Annex I-D)

Protection of com m - l Protection of CCI, unless there l Protection of CCI, trade secrets, intellectual property ercially confidential is an overriding public interest in rights, unless disclosure is in public interest information (CCI) disclosure (Article 81, 4a) (Article 109, 1(b))

CE: Conformité Européenne; CIR: Clinical investigation report; CSR: Clinical study report; CTR: Clinical trial regulation; EC: European Commission; EU: European Union; Eudamed: European databank on medical devices; EudraCT: European Union drug regulating authorities clinical trials; EudraVigilance: European Union drug regulating authorities vigilance; IB: Investigator’s brochure; IMPD: Investigational medicinal product dossier; ISO: International Standardisation Organisation; ICH: International Council on Harmonisation; MAA: Marketing authorisation application; MDR: Medical device regulation a in many instances, the CTR uses the terms study and trial interchangeably.

www.emwa.org Volume 28 Number 2 | Medical Writing June 2019 | 77 Medicinal products and medical devices in clinical trials conduct and disclosure – Billiones and Thomas

European Clinical Trials database [EudraCT]) after the study ends (12 months for studies with privacy by design or by default is a key will be avoided. Once the new portal and adults and 6 months for studies with partici - requirement, i.e., all systems and processes database are fully functional and implemented pants 18 years or younger at the time of should have personal data protection measures (expected to occur later in 2020), the current enrolment); study end is defined as the date of the integrated into them. EudraCT and EU CT registry will be replaced, last patient’s last visit. The CSRs containing following a transition period. 8 summary results of the study will be Confidentially commercial information The European databank on medical devices published 30 days after a marketing authorisation The CTR and the MDR, respectively, consider (Eudamed) , in existence since 2010 9, has been opinion is received (whether positive, negative, the commercial interests of the “pharma” and operating in conjunction with the old directives; or if the marketing authorisation application is “medtech” companies by providing possibilities however, the database was never systematically withdrawn by the applicant). to protect CCI, trade secrets, and intellectual used for investigations with medical devices. The MDR requires a full CIR and a summary property rights. However, there is a caveat in both Through the MDR, the Eudamed structure is of results that can be understood by the intended regulations: protection of CCIs can be overruled broadened and its use becomes mandatory under user (similar requirement as the layperson if their disclosure is in the public interest. the responsibility and auspices of the EC. summary, above). These documents will be Experience with documents that fall under EMA Another substantive change in the new Eudamed submitted to the Eudamed and made available to Policy 0070 – which facilitates disclosure of is the increased transparency of the inves - the public. Unlike the CTR, there seems to be no numerous ‘reports’ of approved products – has tigations, requiring the database to be available intermediate step of clinical study results shown that minimal CCI redactions are accepted for public access. summary posting under the MDR; a CIR is by the EMA. Indeed, all redactions of CCIs need expected within one year of the end of the to be justified in writing and presented to the Public disclosure: clinical study application investigation, defined as the date of the last EMA for a decision; the EMA has the final word The publicly accessible information and docu - patient’s last visit. on the acceptance of a CCI to be redacted. It is mentation used for the applications of clinical For clinical investigations, the MDR requires anticipated that the principles for document trials/investigations submitted via the EU that each step, “from the initial consideration of redaction that apply to EMA Policy 0070 will portal/Eudamed will include information the need for and justification of the study to the also be used for the documents that are required regarding the sponsor, cclinical study protocol/ publication of the results, shall be carried out in to be disclosed by the MDR. 8 clinical investigation plan (CIP) and their accordance with recognised ethical principles,” amendments, investigator’s brochure (for both i.e., ISO 14155:2011 and the most recent version And the twain shall meet medici nal products and devices), and some of the World Medical Association (WMA) The CTR focuses mainly on investigational sections of the investigational medicinal product Declaration of Helsinki (current version dated medicinal products (e.g., drugs and biologics) dossier for medicinal products. 8 There are 2013). The CTR refers to the International and mentions devices only in the context of exceptions as to what can be disclosed including Council for Harmonisation guide - To medicinal product administration protected personal data and commercially lines on good clinical practice ensure synergies and delivery systems. The MDR, confidential information (CCI). and the 2008 version of the which postdates the CTR by Though not clearly described in the WMA Declaration of with the area of clinical three years, refers to the legislations, decisions on publication and sharing Helsinki. Both versions of trials on medicinal products, CTR three times. The of results are expected to be described in the the Declaration of the electronic system on clinical MDR recog nises that clinical study protocol or the CIP as part of the Helsinki include clear investigations [Eudamed] should medicinal products and clinical study application. recommen dations on the interoperable devices may occur registration of clinical be with the together as com bined Public disclosure: clinical study results studies and the publication EU database to be set up for products, a topic that is Both the CTR and MDR require full disclosure of research results in clinical trials on medicinal not addressed in the CTR. of the clinical study results summary based on publicly accessible platforms. products for However, even out side of the the clinical study report (CSR) and clinical context of combined products, investigation report (CIR), respectively. For Personal data protection human use. the MDR states that “to ensure medicinal products, the CTR requires a The strict requirements to protect the synergies with the area of clinical trials on comprehensive summary of the clinical study personal data of study participants in documents medicinal products, the electronic system on results (technical summary) plus a summary that that will be publicly accessible are mentioned in clinical investigations [Eudamed] should be can be understood by laypersons (layperson both the CTR and MDR. Both regulations refer inter operable with the EU database to be set up summary also known as plain language to Regulation (EC) No 45/2001, which has now for clinical trials on medicinal products for summary). These summaries will need to be been superseded by the recently implemented human use.” This is presumably part of the EU submitted to the forthcoming EU portal and will General Data Protection Regulation (GDPR) initiative for standardisation and interoperability be available to the public via the EU database 2016/679. Under the GDPR, the principle of of all electronic health systems in Europe. 11 This

78 | June 2019 Medical Writing | Volume 28 Number 2 Billiones and Thomas – Medicinal products and medical devices in clinical trials conduct and disclosure

interoperability of the two electronic systems will disparity is the large number and diversity of brought to the same level of stringency. Thus, the address the information gap described earlier in medical technology products that may have difference in the impact on the two industries is our article and allow a more comprehensive hindered previous efforts in the regulatory due to the different baselines – the Directives – record of clinical studies conducted in the EU process harmonisation .7 There are approxi - and the change in requirements that the new (regardless of the product type), similar to what mately 500,000 medical technology products in regulations brought with them (Table 2). For is available on ClinicalTrials.gov. Europe. 12 According to Boumans, “on average, those who believe in the two parallel universes more new medical devices enter the European configuration, applying the rules governing Similar contents, different impacts market in a single day than new medicines in a medicinal products to devices was almost a We highlight above the similarities between the year.” 3 Another reason is that not only were the quantum leap into regulatory space. CTR and the MDR in terms of clinical studies, regulatory pathways for the two groups of documentations, disclosure requirements, and products very different previously, the regulatory Are they really that different? the systems supporting such requirements. Yet, requirements in earlier legislations were clearly At first glance, medicinal products and medical despite the similarity of their contents, the impact more stringent for medicinal products than for devices are indeed like “different species”. There of the CTR and the MDR on their respective medical devices. 13 With the passing of the CTR are inherent differences in their appearance, industries are very different. One reason for this and the MDR, these requirements have been mechanisms of action, product development

Table 2. The impact of new regulations on the pharmaceutical and medical device industries

Medicinal Products Medical Devices

Directive 1 Regulation 2 Δ3 and impact 4 on Directives 1 Regulation 2 Δ3 and impact 4 2001/20/EC 536/2014 (CTR) pharma industry 93/42/EEC and 2017/745 (MDR) on medical device + Paediatric 90/385/EEC industry Regulation 1901/ (Baseline) 2006 (Baseline)

Clinical study Mandatory Similar requirements, Small Δ Not clearly required Mandatory for most Large Δ conduct new application when following device classes process Low to moderate “equivalence” route impact (mainly High impact timelines)

Clinical study Mandatory Similar requirements; Small Δ Required but not Mandatory, with Small Δ documents more documents to clearly structured document disclose Low to moderate requirements similar High impact impact to pharma

Clinical trial Mandatory Mandatory Small Δ Not required Mandatory Large Δ registration Low impact High impact

Clinical trial Partial disclosure Full disclosure Large Δ Not required Full disclosure Large Δ results required mandatory mandatory disclosure Moderate to high High impact impact

1 Directive: A “directive” is a legislative act that sets out a goal that all EU countries must achieve. Individual countries devise their own laws to reach these goals. 2 Regulation: A “regulation” is a harmonised legislative act that must be applied in its entirety across the EU member states. 3 Δ: Change from baseline (i.e., Directives and Paediatric Regulation 1901/2006). Low Δ: no or minimal change in requirements; Large Δ: new requirements, substantial changes to previous requirements. 4 Impact is arbitrarily rated as low, moderate, or high, based on Δ and authors’ regulatory experience with the previous and new requirements.

www.emwa.org Volume 28 Number 2 | Medical Writing June 2019 | 79 Medicinal products and medical devices in clinical trials conduct and disclosure – Billiones and Thomas

process, and life cycles. But they also have much presentation November 2018. (Eudamed). Official Journal of the in common. They are products used as medical 2. Choudhury S, Pritchard G. Career European Union 23 April 2010. [cited 2019 interventions in human patients. They have a opportunities in medical device writing - March]. Available at: https://eur-lex. medical purpose, i.e., to cure a disease, treat a Employee and freelance perspectives. Med europa.eu/LexUriServ/LexUriServ.do?uri= condition or control and alleviate symptoms and Writ. 2019;28(1):46–50. OJ:L:2010:102:0045:0048:EN:PDF pain. And their effectiveness and safety need 3. Dunlevy F. Transparency – left to its own 10. EMA/42176/2014 Rev 1. Functional to be demonstrated in clinical trials or devices until now. Med Writ. specifications for the EU portal and EU investigations. It follows that the CTR and the 2017;26(2):29–31. database to Functional specifications for the MDR are also not so different after all, and a 4. European Parliament and Council of the EU portal and EU database to be audited. comparison of their requirements for clinical European Union. Regulation [cited 2019 March]. Available at trials and investigations supports this inference No 536/2014 of the European Parliament http://www.ema.europa.eu/docs/en _GB/ (Table 1). and of the Council on clinical trials on document _library/ . Both the pharmaceutical and medical device medicinal products for human use, and 11. European Commission. EU activities in the industries have had their share of efficacy repealing Directive 2001/20/EC Text with field of eHealth Interoperability and scandals and safety mishaps. 13 The lessons EEA relevance. Official Journal of the Standardisation: an overview. [cited 2019 learned from such events have been used to refine European Union. 2014;L 158:1–76. March]. Available at http://ec.europa.eu/ regulatory requirements that should prevent the [cited 2019 March]. Available at: newsroom/dae/document.cfm?doc _id= same mistakes from happening again. In the era http://ec.europa.eu/health/files/ 3176 . of patient centricity, the type of product eudralex/vol-1/reg _2014 _536/reg _2014 12. MedTech Europe. The European Medical considered – be it medicinal product or medical _536 _en.pdf . Technology Industry – in figures / 2018. device – does not really matter. The benefits and 5. European Parliament and Council of the [cited 2019 April 27]. Available at the risks to the patients through patient-focused European Union. Regulation (EU) https://www.medtecheurope.org/resource medical care are of upmost importance, 2017/745 of the European Parliament and -library/the-european-medical-technology- regardless of which universe they belong to. of the Council of 5 April 2017 on medical industry-in-figures-2018/ . It is likely that the transition to merge the two devices, amending Directive 2001/83/EC, 13. Godlee F. Why aren’t medical devices universes of medicinal products and medical Regulation (EC) No 178/2002 and regulated like drugs? BMJ. devices will take some time. Nonetheless, the Regulation (EC) No 1223/2009 and 2018;363:k5032. alignment of the CTR and the MDR repealing Council Directives 90/385/EEC requirements is paving the way in the direction and 93/42/EEC. [cited 2019 March]. Author information of a single universe. Available at: https://eur-lex.europa.eu/ Raquel Billiones has been a regulatory legal-content/EN/TXT/PDF/ medical writer for more than 13 years and is Acknowledgements ?uri=CELEX:32017R0745. currently Head of Medical Writing at Takeda We thank Sam Hamilton and Clare Chang for 6. Ernst & Young. How the new EU Medical Vaccines in Zurich, Switzerland. Previously, their editing suggestions. Device Regulation will disrupt and she headed a medical writing team in a global transform the industry [white paper]. 2016 clinical research organisation, working on Disclaimers [cited 2019 March]. Available at both pharma and medical devices. She is an The opinions expressed in this article are the https://www.ey.com/Publication/vwLUAs associate editor of MEW and an EMWA authors’ own and not necessarily shared by their sets/ey-how-the-new-eu-medical-device- workshop leader. employers or EMWA. regulation-will-disrupt-and-transform-the- industry/$FILE/ey-how-the-new-eu-medi Kathy B. Thomas is an independent Conflicts of interest cal-device-regulation-will-disrupt-and- consultant and medical writer with more Raquel Billiones is an employee of a pharma - transform-the-industry.pdf . than 20 years of experience in the ceutical company. Kathy B. Thomas is an 7. Behan R, Watson M, Pandit A. New EU pharmaceutical industry and academia. She independent consultant to pharmaceutical medical device regulations: Impact on the has extensive knowledge of clinical trial industry on matters concerning clinical trial medtech sector. Med Writ. 2017;26(2): disclosure USA and EU laws and processes, disclosure. The authors have no other conflicts of 20–4. as well as clinical trial database entries, interest to declare. 8. Thomas KB. Clinical trial disclosure and internal guidelines, and processes to assure transparency: Regulation EU No. compliance. Kathy was previously Head of References 536/2014 Public disclosure at the clinical Medical Writing at Altana Pharma AG in 1. Boumans R. Updates on MDR: trial level. Med Writ. 2018;27(2):7–17. Konstanz,Germany. Kathy can be contacted Transparency Provisions and Eudamed 9. Commission decision of 19 April 2010 on at [email protected] Expansion (Clinical Module). DIA web the European databank on medical devices

80 | June 2019 Medical Writing | Volume 28 Number 2