New amendments to the MDR and IVDR regulations

New amendments on the - somewhat rocky - road of the medical device (MDR) and in-vitro diagnostics  (IVDR) regulations.
Last 23 January 2024 the Commission presented an amendment proposal (COM 2024 –43 final) which was fast tracked through and approved by the EU Council on 24 May. It will shortly be published in the Official Journal (Guce).

The new amended regulations (the number has not yet been noEfied) deal with three specific areas:

• amendments to the Eudamed introducEon Emeframes for both medical devices (MD) and in-vitro medical devices (IVD);
• extension of the transition period for these IVDs (thus modifying the IVDR);
• reporting requirements in the event of MD and IVD suspension.

Let's have a quick look at the various points.

Amendments to the Eudamed introduction timeframes

Eudamed is undoubtedly the backbone of the MDR and IVDR, ensuring its correct functioning. The entire market trading and monitoring system revolves around the database and its transparency objectives.
The Eudamed project is structured around six modules:

1. UDIs/devices;
2. economic operators;
3. notified bodies/ certificates;
4. post-trade and supervisory surveillance;
5. market surveillance;
6. clinical investigations and performance studies.

The first three of these are available today for voluntary use and a further two modules - market surveillance and post-trade and supervisory surveillance - should come out before the end of 2024.

The clinical investigation module will, on the other hand, be ready only from the third quarter of 2026. In order to avoid the postponing of the last module slowing down the funcEoning of the database as a whole (as set out in the current version of the two regulations), the amendment proposal modifies article 123.d of the MDR (and the same is expected to apply to the IVDR) and specifies that the requirements and limitaEons for the individual modules will come into force separately, six months from the date of publicaytion of the notice relating to the specific module.
Eudamed will effectively come into force in a series of stages rather than as a single measure.

Extension of the IVD transition period

As we know the IVDR has brought in some undoubtedly substantial amendments to the IVD laws with significant resource and capacity implicaEons. IVDs are classified as MDs in four risk categories, from A (low risk) to D (high risk). One of the most radical of these is the shift for many devices from Class A to the higher classes, thereby implying the involvement of a notified body (NB). 80% of IVDs will effectively change risk class.

There are, however, currently only 12 NBs and a great many manufacturers will thus not be able to demonstrate conformity with the requirements of the IVDR (there are many reasons for this, including the complexity of these new requirements, a lack of experience in interacEng with noEfied bodies and the ongoing development of the IVDR framework).

The EU is thus assessing - exactly as they did with the MD - the need to introduce a further transition period in order to support devices’ transiEon to IVDR. The new proposed regulation thus modifies article 10 of the IVDR, bringing in the same legal framework as EU regulaEon 2023/607 and sefng out the following dates:

• 31 December 2027 for class D devices;
• 31 December 2028 for class C devices;
• 31 December 2029 for class B devices and for class A devices issued onto the market in sterile condition.

The requisites are identical to those set out in EU Regulation 2023/607.

Reporting requirements in the event of MD and IVD suspension.

Article 10.b applies to both regulations. This norm sets out manufacturer and economic operator obligations to notify the competent authorities/authorised representatives/economic and health operators of any interruption or suspension in MD or IVD supply. This obligation comes into force “where it is reasonably foreseeable that such interruption may result in serious harm or risk of serious harm to patients or public health in one or more Member States”. At least six months’ notice of such interruption or suspension must be given and include the reasons for it.

The last point of the new regulation also sets out an alert system for suspensions and/or interruptions by economic operators, who must notify other economic operators. This is effectively an additional obligation on manufacturers, authorised representatives, importers and distributors and also applies to legacy devices.

It will undoubtedly have an impact on contracts between subjects and will presumably lead to amendments to the Dlgs 137 and 138 penalty framework. It will come into force six months a`er the publication of the new regulations in Guce.