Medical Writing Generics and biosimilars Medicinal products and medical devices in clinical trials conduct and disclosure
mew-generics-and-biosimilarspng

Volume 28, Issue 2 - Generics and biosimilars

Medicinal products and medical devices in clinical trials conduct and disclosure

Abstract

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No. 536/2014 (CTR) and the EU Medical Device Regulation 2017/745 (MDR) in the context of clinical studies and public disclosure. Despite some fundamental differences, similarities and overlaps in the requirements and details between the CTR and MDR are evident. There is also a clear aim for the electronic databases, as described in the two regulations, to be interoperable. This high level comparison of the CTR and MDR shows that while the requirements of the two regulations have been aligned and are very similar, their impact on the respective industries is quite different.

Download the full article

References

  1. Boumans R. Updates on MDR: Transparency Provisions and Eudamed Expansion (Clinical Module). DIA web presentation November 2018.
  2. Choudhury S, Pritchard G. Career opportunities in medical device writing - Employee and freelance perspectives. Med Writ. 2019;28(1):46–50.
  3. Dunlevy F. Transparency – left to its own devices until now. Med Writ. 2017;26(2):29–31
  4. European Parliament and Council of the European Union. Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. Official Journal of the European Union. 2014;L 158:1–76. [cited 2019 March]. Available at: Available from: http://ec.europa.eu/health/files/ eudralex/vol-1/reg_2014_536/reg_2014 _536_en.pdf.
  5. European Parliament and Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. [cited 2019 March]. Available at: Available from: https://eur-lex.europa.eu/ legal-content/EN/TXT/PDF/ ?uri=CELEX:32017R0745.
  6. Ernst & Young. How the new EU Medical Device Regulation will disrupt and transform the industry [white paper]. 2016 [cited 2019 March]. Available at Available from: https://www.ey.com/Publication/vwLUAs sets/ey-how-the-new-eu-medical-deviceregulation- will-disrupt-and-transform-theindustry/$ FILE/ey-how-the-new-eu-medi cal-device-regulation-will-disrupt-andtransform- the-industry.pdf.
  7. Behan R, Watson M, Pandit A. New EU medical device regulations: Impact on the medtech sector. Med Writ. 2017;26(2): 20–4.
  8. Thomas KB. Clinical trial disclosure and transparency: Regulation EU No. 536/2014 Public disclosure at the clinical trial level. Med Writ. 2018;27(2):7–17.
  9. Commission decision of 19 April 2010 on the European databank on medical devices (Eudamed). Official Journal of the European Union 23 April 2010. [cited 2019 March]. Available at: Available from: https://eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri= OJ:L:2010:102:0045:0048:EN:PDF
  10. EMA/42176/2014 Rev 1. Functional specifications for the EU portal and EU database to Functional specifications for the EU portal and EU database to be audited. [cited 2019 March]. Available at Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/.
  11. European Commission. EU activities in the field of eHealth Interoperability and Standardisation: an overview. [cited 2019 March]. Available at Available from: http://ec.europa.eu/ newsroom/dae/document.cfm?doc_id= 3176.
  12. MedTech Europe. The European Medical Technology Industry – in figures / 2018. [cited 2019 April 27]. Available at Available from: https://www.medtecheurope.org/resource -library/the-european-medical-technologyindustry- in-figures-2018/.
  13. Godlee F. Why aren’t medical devices regulated like drugs? BMJ. 2018;363:k5032.

Search

Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: