The new EU Medical Device Regulations were adopted by the European Parliament on 6 April 2017. The Regulations are set to be published in the Official Journal of the European Union in May, following which the new Regulations will enter into force in three years for medical devices (2020), and in five years for IVDs (2022).
For further information and analysis on the new Regulations, please read our series of Knowledge Bites briefings:
- Knowledge Bites, Part 1: Unannounced audits – New Medical Device Regulations
- Knowledge Bites, Part 2: Supply chain division of responsibility
- Knowledge Bites, Part 3: How does the new scrutiny procedure look?
- Knowledge Bites, Part 4: Post market surveillance will now require periodic updates
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.