The European Commission has announced a proposal to delay the implementation of Regulation (EU) 2017/746 on In Vitro Diagnostic medical devices (IVDR).
Although the IVDR has applied since 2022, data has shown that many manufacturers have not taken the plunge to transition to the new regulation. The previous EU Directive 98/79/EC covering IVDs was considered a very lenient Directive, with most IVDs (including some considered to be high-risk) falling under General IVDs and being made available on a self-declaration basis. The EU IVDR changed all of that with a new classification system as well as clearer and stricter requirements all around.
Included in this steep learning curve is an increase in regulatory cost, especially if most of these manufacturers now need to contact a notified body for assessment. For many small manufacturers, this may be a burden that they may not be able to justify.
On the other hand, you may get some other manufacturers digging their heads in the sand. The “Let’s wait it out, folks” approach. This proposal may favour these organisations the most.
To lessen the impact on the healthcare systems, the Commission is recommending an extended transition period depending on the IVD risk classification. Under the new rules:
- Class D would have a transition period until December 2027;
- Class C would have a transition period until December 2028;
- Class B and Class A sterile devices would have a transition period until December 2029.
This proposal will now be put forward to the European Parliament and Council for adoption.
We’ll keep you updated with any further announcements. If you’re having trouble transitioning to meet your IVDR obligations, get in touch!