Volume 28, Issue 2 - Generics and biosimilars

Medicinal products and medical devices in clinical trials conduct and disclosure

Authors: Raquel Billiones, Kathy B. Thomas

Abstract

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.