Another date for the event
For those interested from the Americas, we have another date on the following date
May 28, 2024, 05:00–06:30 PM (CET)
The European Economic Area is an attractive sales market and distribution target for medical devices and IVDs. The MDR and IVDR provide a standardized set of regulations that reflect the special requirements for medical devices and IVDs. However, the conformity of products with the requirements of MDR and IVDR is only the obvious starting point. Medical devices and IVDs very often also need to satisfy further regulatory requirements.Legislation as part of the European Green Deal has significantly tightened existing requirements or implemented new regulations, including the REACH Regulation (PFAS requirements), the RoHS Directive, the Ecodesign Directive, the Green Claims Regulation, the Battery Regulation, and packaging regulations, to name but a few. Digital products or those with AI components must also meet cybersecurity requirements and the requirements of the AI Act.
This webinar is a joint event organized by MT Promedt Consulting and reuschlaw. MT Promedt Consulting provides an update on the services of an EC REP and the lessons learned from the perspective of the EC REP in dealing with the requirements of the MDR and IVDR since their entry into force. reuschlaw addresses further regulatory requirements for medical devices and IVDs which are not governed by the MDR and IVDR and not covered by an EAR but obligatory for their marketability in the European Economic Area.
Session 1: EU Regulatory Framework – the full scale for medical devices
Speaker: Miriam Schuh, Head of Healthcare, reuschlaw
- European regulation over the entire product life cycle
- Digital products, digitalization, AI Act
- Product liability, liability risks for economic operators
Session 2: MDR and IVDR – Lessons learned from an EC REP perspective
Speaker: Clemens Mohr, Head of European Authorised Representative, MT Promedt Consulting GmbH
- Technical documentation under MDR and IVDR
- Manufacturer’s vigilance obligations
- EC REP vs. UKRP vs. CH REP
Participation for clients, SMEs, industry etc. is free of charge. Participation as an external consultant is subject to a fee. We charge a net fee of €599 for participation in the event, payable within 14 days of registration. If you would like to participate as an external consultant, please contact marketing@reuschlaw.de.