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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

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28.10.2021

HAS THE PENNY DROPPED?

New transitional periods could provide for an equalisation of the approval process for in vitro diagnostics and the associated requirements. But nothing has been finally decided yet!

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Gradation of transitional periods for the Regulation on in vitro diagnostic medical devices

As is already well known, according to the current plan, the IVDR 2017/746 will replace Directive 98/79/EC (IVDD) on 26.05.2022. Now, on 14.10.2021, news reached us that will probably relieve many manufacturers of medical devices, but also other economic actors, users and patients. Together with the MDCG, the EU's DG Sante, which is responsible for medical devices, created a joint implementation plan for the IVDR in June 2021, indicating that surveys had identified bottlenecks in the implementation of the IVDR and the need for legislative intervention.

Based on this, there is now a proposal from the EU Commission to amend the In Vitro Diagnostics Regulation 2017/746.
Among other things, it was recognised that with the IVDR, many more manufacturers would need a Notified Body for their medical devices (over 24,000 products compared to 3,300 products under the IVDD, source: md_2017-746-regulation_2021-amendment_en.pdf[europa.eu]). However, so far there are only six notified bodies for the IVDR, with eleven applications currently still on hold (as of 20.10.2021, source EUROPA-EuropeanCommission – Growth-Regulatorypolicy – NANDO).

It was also recognized that a mere postponement of the applicability deadline of the regulation of in vitro diagnostic medical devices would not be sufficient or possibly counterproductive. For comparison: In the context of the postponement of the MDR, the Notified Bodies had to deal more with applications for the renewal of MDD certificates in the "gained year" than with the preparation and implementation of the MDR.

The amendment proposal now on the table seeks to phase in IVDR 2017/746.
High-risk products are to be prioritised and the validity period of IVDD certificates is to be extended by one year.
 

In concrete terms, this would mean for in vitro diagnostics manufacturers:

Certificates issued before 25.05.2017 in accordance with Directive 98/79/EC, as set out in Annex IV, will remain valid until 27.05.2025 – i. e. one year longer. Also type examination certificates according to IVDD.

For devices that are newly classified by the IVDR and now require the involvement of a Notified Body for the first time, the following deadlines shall apply with regard to the transition periods:

  • 26.05.2025 – Class D
  • 26.05.2026 – Class C
  • 26.05.2027 – Class B
  • 26.05.2027 – Sterile Class A

Until these deadlines, devices with a declaration of conformity according to 98/79/EC could be placed on the market, provided that the declaration of conformity was issued before 26.05.2022 and there were no relevant changes to the medical devices.

However, the requirements for post market surveillance, vigilance and the registration obligations under IVDR must still be taken into account for all products from 26.05.2022.

Regardless of this, manufacturers of Class D products who now need a Notified Body for the first time should hurry. No certificate has yet been issued for a Class D product (as of 09.09.2021)!

The proposed amendments do not imply extended deadlines for in vitro diagnostic medical devices that do not require the intervention of a notified body. These are on the one hand

  • non-sterile class A products, which account for about 20 % of the market (source: MedTech Europe Survey Report, footnote 2), and secondly
  • "new" in vitro diagnostic medical devices for which no certificate or declaration of conformity has yet been issued in accordance with Directive 98/79/EC.

The IVDR is expected to apply in full to these products from 26 May 2022.

In general, it is advisable for IVD manufacturers not to deviate from the planned timetable now, because what has been described is so far only an amendment that has not yet been adopted by the EU. It is to be hoped, of course, that in view of the MDR experience the penny has dropped that a staggered solution, such as the one proposed here, is probably more expedient than simply postponing the start date.

If you would like support with the implementation of the IVDR requirements now and independently of the political development, we would be pleased to hear from you. We would be happy to support you in the already acute topics of PMS, vigilance and registration as well as in the later relevant topics such as performance assessment, technical documentation and certification.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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