UPDATE OF 20 DECEMBER 2021
UPDATE IVDR (EU) 2017/746.
Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation!
The European Council have join the Parliament in adopting the proposal for IVDR transition!
The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the European Parliament and the Council.
European Parliament legislative resolution of 15 December 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices
On October 14, 2021 the European Commission published a proposal to postpone the IVDR (EU) 2017/746 Regulation full application deadline (May 26, 2022) regarding In Vitro Diagnostic Medical Devices.
Following significant delays in IVD sector in adjusting to the Regulation which replaces IVDD Directive 98/79/CE, and the requests from the EU member States, the European Commission took action to avoid possible disruptions of crucial public health devices supply.
According to Article 110 of the (EU) 2017/747 Regulation, only devices with a certificate issued by a Notified Body already in accordance with Directive 98/79/CE (around 8%) will benefit from transitional provisions, which the European Commission suggests enlarging to all IVDs, extending the transitional period deadline.
Why such a proposal?
In favour of the necessity of a postponement, the Commission highlighted that about 70% of clinical decisions are taken using of In Vitro Diagnostic Medical Devices such as HIV tests, pregnancy tests, or SARS-CoV-2 tests, and it has underlined the high number of small and medium enterprises (SMEs) active in the field.
While with IVDD Directive just about 8% of all In Vitro Diagnostic Medical Devices on the market required the participation of Notified Bodies and their conformity assessment, with the IVDR (EU) 2017/746 Regulation, around 80% of In Vitro Diagnostic Medical Devices will undergo assessments by Notified Bodies. This means that, before placing their products on the market, Manufacturers will have to appoint a Notified Body to obtain one or more certificates after having completed a proper conformity assessment procedure, which will take at least one year on average.
Two main factors have emerged from these important and demanding features, which according to the Commission, justify the need of postponing the transitional period deadline
- COVID-19 pandemic and public health crise.
- Shortage of appointed Notified Bodies.
The COVID-19 pandemic on one hand increased the necessity of safe In Vitro Diagnostic Medical Devices, but on the other has subjected health workers to pressures, new duties and priorities, an increased amount of workload and difficulties which hindered the adjustment activities to IVDR (EU) 2017/746 requirements.
In addition to this issue, there is a severe shortage of appointed Notified Bodies in accordance with the (EU) 2017/746 Regulation, moreover, established only in three Countries (Germany, France, and the Netherlands). This situation prevents Manufacturers from carrying out the planned conformity evaluation procedures on time.
Due to the lack of Notified Bodies with the full application of the 2017/746 Regulation on May 26, 2022, several companies would be unable to market their own Medical Devices, with severe consequences on the whole sector and on public health.
Postponement proposal: contents and deadline
Here below we present a summary of contents while waiting for the final decision on the proposal by the European Parliament and Council.
Starting from May 26, 2022, only Class A non-sterile IVD Devices should comply with IVDR (EU) 2017/746. According to the class risk, several deadlines have been proposed for the other devices, to give Manufacturers the time to adjust to IVDR requirements.
Quoting the proposal document: In Vitro Diagnostic Medical Devices for which, according to the conformity assessment procedure under the IVDD Directive, it was not necessary the involvement of a Notified Body; for which a conformity evaluation procedure under the Directive has been drafted prior to May 26th, 2022, and for which a conformity assessment procedure under IVDR Regulation requires the involvement of a NB; can be placed on the market until the following dates:
- May 26, 2025, for Class D IVDs
- May 26, 2026, For Class C IVDs
- May 26, 2027, for Class B IVDs
- May 26, 2027, for Class A IVDs on the market under sterile conditions.
Furthermore, regarding devices with already issued certificates:
- Certificates issued by Notified Bodies in accordance with Directive 98/79/CE (IVDD) should be valid until May 27, 2025, rather than May 27, 2024, as it currently is required by the IVDR (EU) 2017/746 Regulation;
- IVD Devices lawfully placed on the market under IVDD Directive before May 26, 2022, and IVDs placed on the market starting from May 26, 2022, under a valid certificate, may continue to be on the market until May 27, 2025.
Do you need any help in adjusting to IVDR (EU) 2017/746?
Thema experts are available for a customised consultation on IVDR (EU) 2017/746.
In addition, Thema experts designed IVDR Emergency Kit: a box with templates and standard technical papers for In Vitro Diagnostic Medical Devices Manufacturers, Vendors and Distributors to adjust to the main IVDR (EU) 2017/746 requirements quickly and independently, saving both time and costs.
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices, October 14, 2021