The EU have swiftly issued this Q&A document after fast-tracking Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
It’s an interesting document and some will certainly find the information helpful, but in truth, this only clarifies what is already known in previous communications:
- Certificates can be extended by EU law provided a certain criterion is met.
- Notified bodies can confirm by letter to manufacturers that they have a contract for the MDR.
- Manufacturers seem to have the ability to self-declare their compliance.
- Manufacturers don’t need to wait if they comply with the requirements they can continue to sell.
- Notified bodies will continue their surveillance activities.
- The sell-off period has been removed.
- And other information.
What could possibly go wrong?
Expect questions from your distributors and importers and other customers looking for proof or evidence from a third party that compliance has been achieved. The problem here is this is likely to be achieved though an application for a Certificate of Free Sale which are issued by Competent Authorities. How will they approach this? they are unlikely to accept a simple declaration from a manufacturer.
As an Authorised Representative, we could review a manufacturer’s documentation and evidence to declare that the applicable criteria have been met and then issue a declaration to confirm this. This will likely work inside the EU where confirmation is requested, but at this point cannot guarantee this.
Outside the EU, these territories are almost definitely going to insist on a Certificate of Free Sale.
For the Q&A Document, please click here.
For more information and the potential fees email info@advena.mt
