The new in-vitro diagnostic regulation (IVDR) entered into force on 26 May 2017. As the date of application for the IVDR is 26 May 2022, 20% of the transitional period of five years has already passed. This is a good opportunity to summarise the current situation.
The most important changes
Some of the most important changes that have taken place so far include:
- A new classification system
- Extension of the scope
- Stronger surveillance and stronger involvement of notified bodies
- Increased requirements for economic operators
- Designation of a responsible person is explicitly required
- Increased requirements for transparency and traceability
- Introduction of unique device identification (UDI) and European Databank on Medical Devices (Eudamed) database
- Increased requirements for technical documentation / clinical evidence
- Increased post-market surveillance requirements
IVDR-compliant devices prior to may 2022
All products, irrespective of their risk class, may be first made available before 26 May 2022 in accordance with IVDR, but the following restrictions have to be taken into account:
- If the conformity assessment of a product requires the involvement of a notified body (NB) due to its risk class, the NB must be designated and notified in accordance with the IVDR
- For class D devices, appointments to the medical device coordination group (MDCG) and expert panels (26 November 2017) and of EU reference laboratories (prior to 25 November 2020) have been made
Availability of notified bodies
Since November 2017, the designation codes for IVDs are published and NBs can express their interest in designation under the medical device regulation (MDR) or IVDR.
Interestingly, a recent member survey by Team-NB showed that only 55% of the Team-NB members intend to submit their application to be designated against the IVDR. Although the survey covered only less than 50% of the 59 notified bodies operating in Europe, those numbers indicate that significant less NB will be available.
This development, together with the fact that under IVDR around 80% of the IVD products need NB involvement for conformity assessment, leads to an alarming increase in NB workload and product CE certification bottleneck.
The creation of Eudamed is one key aspect in fulfilling the objectives of the IVDR. The project has recently (12 April) taken an important step forward as Industry and European competent authorities had the opportunity to test the first module, entering of actor data.
Despite many concerns and still big challenges to be overcome, Eudamed will likely be ready as planned on 25 March 2020.
Things to do
You should already have classified your products, undertaken a gap assessment and identified the profitable products.
You should now start to close the gaps resulting from the IVDR.
anteris medical and anteris diagnostics are here to support you in all areas of this challenging project.
The firm offers effective project management, tying together your internal organisation, development partners, suppliers, notified bodies, and regulatory agencies.
anteris medical is a lifesciences and engineering major with dozens of years of experience in CE marking, 510(k) submissions and quality systems regulations in all major markets.