European Parliament and Council of EU “Not Far Apart” On Scrutiny
This article was originally published in Clinica
The scrutiny of high risk medical devices and the more risky IVD medical devices has at long last made it onto the agenda of the joint talks between the European Parliament, Council of the European Union and the European Commission which were held on December 3.
You may also be interested in...
Those marketing products covered under the EU’s MDR and IVD Regulations have plenty of reading this month to help them prepare. More details have also emerged about the UK’s regulatory future.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.