European Commission Proposes IVDR Transition Assistance…
…to Keep IVD Products on the Market and Available to Patients
On the 14 Oct 2021, the European Commission released a proposal for amended transitional arrangements to Regulation (EU) 2017/746 (IVDR) as the industry moves closer to the Date of Application (DOA) of 26 May 2022.
There has been growing pressure from industry to delay the transition to IVDR in light of the global COVID-19 pandemic and the limited number of Notified Bodies designated to operate and support the review of products, six to date.
However, if anyone was expecting a delay of transition, then they will be disappointed. The proposed transitional arrangements are there to support two main scenarios:
- Devices that have a valid certificate issued by a Notified Body under Directive 98/79/EC (IVDD)
- Devices that have a valid declaration of conformity drawn up under Directive 98/79/EC (IVDD)
In other words, products that are already on the market. The following products will still need to comply with the IVDR from 26 May 2022:
- New products placed on the market
- Products that undergo a significant change to the design and intended purpose after the DOA
- Products that require no Notified body involvement i.e. Class A devices under IVDR
Given the emphasis placed on the management of significant changes to products, specifically around the design and intended purpose, manufacturers would do well to ensure that they review and improve their Quality Management Systems (QMS) to ensure that changes to products are managed appropriately.
Further, the new arrangements also state that Post Market Surveillance, Market Surveillance, Vigilance and the registration of Economic Operators and products, according to IVDR, will still apply from 26 May 2022. Until specifically made clear by the European Commission, IMed understands that this requirement refers to the articles of Chapter VII Post Market Surveillance, Vigilance and Market Surveillance and Article 26 Registration of Devices, Article 27 Electronic System for Registration of Economic Operators, Article 28 Registration of manufacturers, authorised representatives and importers and the relevant parts of Article 30 European Database on Medical Devices. These Chapters and Articles make further references throughout the IVDR and Manufacturers will need to navigate the extent to which they must maintain their compliance carefully. An example is the reference in Article 78 to Performance Evaluation and the need to update the technical documentation accordingly.
However, what is clear is that these arrangements are not an excuse to sit back and relax but are there to ensure that patients in Europe have access to the tests they need in these challenging and unprecedented times.
The Headlines are:
- These transition arrangements are currently a proposal and need to be confirmed however, we fully expect them to be
- New products placed on market after 26 May 2022 must comply with IVDR in full from date of application (DOA), 26 May 2022
- CE Certificates issued by Notified Bodies after 25 May 2017 under the IVDD are valid until 26 May 2025
- All products must comply with Post Market Surveillance, Market Surveillance, Vigilance, Registration of Economic Operators and Products in EUDAMED according to IVDR from the DOA
- IVDs classed as General IVDs under IVDD, with a Declaration of Conformity (DoC) dated before 26 May 2022, that have no significant changes to design or intended purpose and which are:
- Class D under the IVDR can placed on the market until 26 May 2025
- Class C under the IVDR can placed on the market until 26 May 2026
- Class B and Class A Sterile under the IVDR can placed on the market until 26 May 2027
- Products placed on the market according to point 5 can continue to be made available or put into service for the following periods:
- Class D 26 May 2026
- Class C 26 May 2027
- Class B and Class A Sterile 26 May 2028
- Lab Developed tests can:
- defer the application of most of the conditions (IVDR Article 5) to be met by health institutions making in-house devices by 2 years until 26 May 2024.
- The requirement for the justification that there is no equivalent CE marked device available to meet the target patient group’s specific needs is proposed to be deferred even further, until 26 May 2028.
- Products that are Class A under the IVDR are required to comply with the IVD Regulation from the DOA (26 May 2022).
Head of In Vitro Diagnostics