Alliance of European Life Sciences Law Firms
Gezondheids.org – Gezondheidszorg en ICT
Description: Medical devices legal and regulatory blog
Medical devices legal and regulatory blog
Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today , number L080. As you are reading this, the amendment now applies all throughout the Union as referenced in article 1 MDR and IVDR. Union as in not European Union, which is something different. This is one of the most often made mistakes in relation to the application of the MDR and IVDR: people (among which even the MDCG in some cases, such in as MDCG 2019- 7 re
Asking about the MDR or IVDR ’s geographic scope is a good test to determine if regulatory people really understand the subject matter. Because if you think it’s limited to the EU only, you are missing countries where the MDR and IVDR apply, and some pretty major ones at that (like Turkey). If you want to know also in exactly which overseas territories of these Union member states or exotic corners of Europe like Svalbard (also known as Spitsbergen) or the Holy See the MDR and IVDR apply and do not apply, c
Alliance of European Life Sciences Law Firms
Gezondheids.org – Gezondheidszorg en ICT