From May 27, 2022 00:00 am it is compulsory to apply Regulation (EU) 2017/746 IVD (Regulation on In Vitro Diagnostic Medical Devices).
The European Union is very slow to perform the tasks assigned to it by the regulation.
Where are we today when almost all the requirements should have been fulfilled according to the original idea?
- Overall, seven IVDR notified bodies have been awarded notification, whereas the number of certifications to be issued has increased fourfold compared to the period regulated by the European Union directive.
- All in all, three out of six planned EUDAMED modules are in operation. According to the latest official information, EUDAMED is to be fully operational in the second quarter of 2023.
- Altogether, 11 harmonized standards have been released, whereas no Common Specification has been issued so far.
- Not more than 8 MDCG Guidances have been published, including five guidances issued this year.
With Regulation (EU) 2022/112 of 25 January 2022, the European Parliament and the European Council extended the IVDR transition period in terms of medical devices subject to certifications issued in line with Directive 98/79/EC. Accordingly, according to risk classification, manufacturers must comply with the IVDR requirements in a transitional period expiring on May 26, 2028. It is worth revising the mandatory requirements applicable from today onwards:
Class A: non-sterile medical devices are not subject to the transitional period. The full application of IVD Regulation is mandatory for manufacturers of these devices.
Newly designed devices are not subject to the deferred application of IVDR, either. Consequently, in the case of ongoing product developments, conformity assessments must be conducted in line with the IVD Regulation.
Like MDR, IVD Regulation introduced the category of legacy devices. Nevertheless, in connection with MDR we can experience that several manufacturers ignore an important condition of the transitional provisions, i.e. “this regulation (IVDR) must contain the requirements for post-market phase surveillance, market surveillance and vigilance, in addition to applying the requirements concerning the registration of economic entities and devices instead of the relevant requirements of the 98/79/EC Directive (IVDD)”. Accordingly, it was mandatory for every manufacturer to prepare and apply the procedures related to IVDR PMS activity, vigilance, and registration by the deadline of introducing the IVD Regulation.
Therefore, the full application of IVDR is very distant. There are several tasks to be solved by both the manufacturers and the relevant organisation of the European Union.