On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:
- extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
- allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
- include a notification obligation in case of interruption of supply
The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.
Extension of transition provisions under the IVDR
Many of you will recall that, and as set out in a previous blog post, on 20 March 2023, the transition periods under the MDR were extended and the ‘sell-off’ deadline, after which medical devices and IVDs would have to be withdrawn from the EU and EEA market, was abolished. The extensions to the transition period in the MDR did not, however, apply to IVDs under the IVDR.
In January 2022, a staggered extension of the IVDR transition period was adopted, ranging from 26 May 2025 for higher risk IVDs to 26 May 2027 for lower risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions. After the extension to the MDR, we predicted that the current transition periods under the IVDR would also be extended, due to the limited capacity of Notified Bodies to undertake conformity assessments and the complexity of the new rules under the IVDR. Notably, currently only 12 Notified Bodies are designated under the IVDR, compared to 22 designated under the old regime.
Since a significant number of IVDs that are on the EU market do not yet comply with the IVDR, our prediction has come to fruition. The Commission’s proposals aim to ensure availability of IVDs by extending the application of the old EU regime governing IVDs, the In Vitro Diagnostic Medical Device Directive (IVDD), for certain IVDs. These periods do not apply to new IVDs.
New transition periods
Under the proposal, the transition period in the IVDR for certain IVDs will be extended to:
- December 2027 for Class D high individual and public health risk devices (e.g., HIV or hepatitis tests)
- December 2028 for Class C high individual and/or moderate public health risk devices (e.g., cancer tests)
- December 2029 for Class B lower risk devices (e.g., sterile devices such as blood collection tubes)
The above extensions apply to IVDs for which a conformity assessment procedure pursuant to the IVDD did not require the involvement of a Notified Body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD, and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a Notified Body.
An extension until 31 December 2027 applies in the following circumstances:
- Certificates issued by a Notified Body under the IVDD that were valid on 26 May 2022 and have not been withdrawn. The extension is directly applicable, so that Notified Bodies are not required to change the date on the individual certificates. The length of the extension of the certificate’s validity corresponds to the length of the extended transition period.
- Where a certificate issued by a Notified Body has already expired when the proposed amendment comes into force (but was valid on 26 May 2022), the extension will be subject to the condition that, before the date of expiry, the manufacturer has signed a contract with a Notified Body for the conformity assessment of the IVD in question under the IVDR. Alternatively, if no such contract has been signed prior to expiry, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 54 of the IVDR, or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 92 of the IVDR.
Furthermore, for the new transition periods to apply, certain conditions must be met:
- the IVD continues to comply with the IVDD
- the IVD has not been subject to significant changes in its design or intended purpose
- the IVD does not present any unacceptable risk to health or safety of any user, or to public health
- the manufacturer put in place an IVDR compliant quality management system no later than 26 May 2025
- when required, the manufacturer must submit a formal application to the EU Notified Body by 26 May 2025 (class D), 26 May 2026 (class C) or 26 May 2027 (class B and A sterile IVDs) for the conformity assessment of the ‘legacy device’ covered by an IVDD certificate or declaration of conformity, or in respect of a device intended to substitute that device under the IVDR. Within four months thereafter, the application must be covered by a written agreement between the manufacturer and the Notified Body.
Rules in the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply notwithstanding any application extension period.
- Eudamed – Under the MDR and IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). The Commission has proposed to accelerate the launch and mandatory use of Eudamed for modules that are already available and functioning correctly from end 2025. This is a departure from the current rules, according to which Eudamed would only become mandatory when all the modules were functioning correctly. The Commission considers that use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices.
- Shortages – The proposal introduces a requirement for manufacturers to give prior notice to authorities, economic operators and/or health institutions in case of interruptions to the supply of IVDs or medical devices that would create a risk to patients, before they cease, temporarily or permanently, the supply of a critical device.