Concerns on implementation of IVD Regulation and potential impact on urological care

In vitro diagnostics play a crucial role in urological diagnostics and care, from simple blood tests such as PSA tests, and urine tests to tumour markers for testicular cancer and tests revealing genetic abnormalities. On 16 January, the Biomed Alliance issued a statement voicing concerns about implementing the new European Union IVD Regulation.

There are widespread issues with the implementation of the IVDR, the preparedness of the diagnostic sector, and the regulatory pathways to conformity assessment. This situation will likely lead to substantial shortages of essential IVDs across Europe.

“I am seriously concerned about the impact of the implementation challenges of IVDR on urological care. I urge the European Commission and EU Member State regulators to find practical solutions to respond to these challenges as a matter of urgency”.

A variety of short-term measures and medium to long-term reform is necessary to prevent a large-scale shortage of CE-Marked IVDs:

• An urgent extension of the transition periods for all IVD classes will provide much-needed breathing room to the sector

• EUDAMED must be fully implemented and widely used as soon as possible

• Special regulatory pathways to facilitate the conformity assessment of rare/niche/orphan IVDs should be created

• Additional efforts are required to raise awareness and to provide support and guidance for IVD manufacturers, particularly SMEs

• There is a need to simplify the re-certification of legacy devices, that have been successfully on the market without safety issues for several years

• There should be a legislative requirement for manufacturers to report to laboratory professionals and regulators when they intend to take an IVD or medical device off the market at least 6 months before withdrawal

• While In-house IVDs (IH-IVDs) could fill the “CE gap”, Article 5.5, including the requirement of no equivalence to CE-IVDs, discourages their development due to the additional administrative burden and uncertainty of sustainability for IH-IVDs.

EAU is a prominent and active member of the Biomed Alliance, with Anders Bjartell representing the EAU on the IVD working group. See the full statement here: Statement prevention shortage IV Ds final 16 01