Multi-stakeholder workshop to support implementation of the Medical Devices Regulation on drug-device combinations
EventHumanResearch and development
Date
- Tuesday, 31 March 2020
Location
- European Medicines Agency, Amsterdam, the Netherlands
Update: In the context of the escalating situation with the COVID-19 outbreak, this workshop will not take place as planned on 31 March 2020. EMA is currently exploring options for the workshop to be held at a later date or remotely (via webinar). EMA will publish further information in due course. |
The European Medicines Agency (EMA) is holding this multi-stakeholder workshop in preparation of 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 2020.
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 an interactive 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.
The aim is to further clarify expectations on roles and responsibilities in the future regulatory review process and dossier requirements for initial marketing authorisation and post-authorisation applications.
EMA aims to ensure a balanced representation of stakeholders and will allocate available places accordingly. It is also possible to follow the workshop remotely via a live broadcast on this page.
To register, send an email including your contact details and affiliations, briefly citing your relevant experience and interest in the topic and whether you wish to attend in person or remotely.