26th may 2022: applied the Reg. (EU) 2017/746 on IVDs
On May 26th, 2022, Reg. (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into full effect, after coming into force on May 25th, 2017. The text introduces many novelties, which required and will still require the proper amount of work by all the stakeholders, manufacturers in first place.
The changes
When compared to the previous regulatory regime, the field of application of the law text appears to have been extended. This in order to regulate those devices manufactured within health institutions, diagnostic services – including online ones – and all those IVDs intended to provide informations on the patient’s predisposition to a specific clinical condition or disease.
One of the substantial changes also concerns the classification of the IVDs themselves, which, contrary to the one according to Dir. 98/79 / EC, will no longer be based eclusively on their intended use (Annex II list A or B, other type of IVD or self-testing IVDs).
The associated risk will now be taken into account (similarly to what already happens for medical devices), introducing, in increasing risk order, class A, B, C and D. The legislator has therefore also introduced classification rules and new conformity assessment procedures.
To this must be added, as in the case of Regulation (EU) 2017/745 on medical devices, all the new obligations for manufacturers, EU authorized representatives, importers and distributors, including, just to name a few, the prescriptions relating to the person responsible for regulatory compliance (PRRC), the obligations related to the European database EUDAMED and all the obligations relating to the UDI system (unique device identifier), essential in the field of device traceability.
Worthy of attention are the new vigilance and surveillance requirements, as well as the new IVD performance requirements. Brand new are the “European Union reference laboratories“, introduced to help in the conformity assessment of class D devices and, under request of Member States, to verify the compliance of class C devices.
The state of the works
The implementation and practical application of such a complex legislative text requires a huge effort, both by the industry and by the institutions themselves.
To this date, however, there are some issues: the change in the classification rules of IVDs brings in one of them. It should be noted that a very large percentage of the products currently on the market as “other type of IVD” according to the Directive (and therefore CE marked in self-declaration by the manufacturer), according to IVDR, require now the intervention of a notified body in the conformity assessment procedure, making the whole process more demanding for the manufacturer in terms of time and costs.
As a consequence, it is plausible that it will not be sufficient to designate 21 NBs (as for Dir. 98/79 /EC) to deal with all the new workload and the situation results even more worrying when taking into account that today only 7 NBs obtained the designation for the Reg . (EU) 2017/746, with very long certifications queues already.
The situation was serious enough for the Commission to expand the transitional provisions (Article 110) through the Reg. (EU) 2021/112, formalizing in fact the progressive application of the IVDR (with a grace period that arrives to 2027 for some IVD classes) and avoiding, at least in the immediate future, the unavailability of devices essential for the European market.
To this must be added the current absence of European Union reference laboratories and common specifications; must be said, though, that the European Commission is already working on these issues.
As for medical devices, the EUDAMED database plays a fundamental role in the field of in vitro diagnostic medical devices, especially in terms of vigilance and surveillance.
However, currently only the first three modules are functional (economic operators, UDI and devices and certificates).
Di Renzo Regulatory Affairs is committed to constantly monitor the regulatory landscape and, while waiting for the completion of the regulatory infrastructure, is already at disposal of the economic operators in order to support them in reaching the compliance to the new legal provisions introduced by Reg. (EU) 2017/746.
Scritto da: Riccardo Del Signore
Foto di Pete Linforth da Pixabay
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