Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations
Table of contents
This multi-stakeholder workshop is held in preparation for the changes introduced by Article 117 of Regulation (EU) 2017/745 on medical devices (MDR) for integral drug-device combinations (products falling under the second sub-paragraph of Article 1(8) and Article 1(9) of the Regulation.) These require notified bodies to be involved in the assessment of certain drug-device combinations from 26 May 2021.
For more information on the changes on drug-device combinations, see Medical devices: Medicinal products that include a medical device (‘combination products’).
The workshop will facilitate a discussion and an exchange of views and experience based on practical examples between European Union regulators, the European Commission, notified bodies, the pharmaceutical industry and medical-device manufacturers.
It will address, in particular:
- lessons learned from notified body opinion process thus far;
- lifecycle management, including ‘substantial design changes’.
There is limited capacity for verbal contributions during the webinar. EMA encourages interested participants to send questions ahead of the webinar.
EMA will address any unanswered questions in a forthcoming update of the
question and answers on implementation of MDR Article 117
.
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Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations (PDF/134.82 KB)
Adopted
First published: 23/11/2020
Last updated: 27/11/2020
EMA/128303/2020 -
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Presentation - Welcome and introduction - Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations (PDF/444.8 KB)
First published: 22/01/2021 -
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Presentation - Team NB: Feedback on notified body opinions to date (Julia Frese, Jonathan Sutch) (PDF/665.63 KB)
First published: 22/01/2021 -
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Presentation - Team NB's perspective on life cycle management under Article 117 / MDR (Petra van Leeuwen, Colm O’Rourke) (PDF/977.52 KB)
First published: 22/01/2021 -
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Presentation - Lifecycle management: Substantial and non-substantial changes for drug-device combinations (Amanda Matthews, Tim Chesworth) (PDF/762.49 KB)
First published: 22/01/2021 -
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Presentation - The notified body opinion: Industry experiences (Bjorg Hunter) (PDF/10.75 MB)
First published: 22/01/2021 -
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Presentation - The notified body opinion: An assessor’s view (Maeve Lally) (PDF/565.22 KB)
First published: 22/01/2021 -
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Presentation - EMA considerations on lifecycle management in the context of Article 117 (Pascal Venneugues) (PDF/560.99 KB)
First published: 22/01/2021