The European Commission has published a draft Implementing Regulation containing ‘common specifications’ for certain in vitro diagnostic medical devices (IVDs) falling in Class D under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR). Categories of products covered include those for detecting and/or quantifying certain infectious agents (including HIV, hepatitis B, C, D and SARS-CoV-2) and those for determining human blood groups. The Commission’s consultation on the draft Implementing Regulation is open for feedback until 9 March 2022.
The common specifications are intended to, in effect, put flesh on the bones of the general safety and performance requirements contained in the IVDR, providing manufacturers with detailed specifications for complying with the more generally worded legal requirements. Similarly as for EU-recognised harmonised standards, compliance with applicable common specifications for a specific product type gives rise to a legal presumption of conformity with the relevant general safety and performance requirements in the IVDR.
Considering the products covered by the draft common specifications will be subject to more stringent conformity assessment procedures under the IVDR – involving, for the first time in the case of a number of the in-scope IVDs, a Notified Body, as well as verification by an EU reference laboratory – the common specifications will provide some welcome clarity to manufacturers regarding the specific requirements their IVDs should meet.
Manufacturers of in-scope Class D IVDs should nevertheless review the draft common specifications applicable to their products to consider whether these are appropriate for the IVD in question, are sufficiently clear and are attainable. This is particularly true considering the IVDR places an express obligation on manufacturers to comply with applicable common specifications unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent to the common specification.
The much delayed common specifications will only come into force around the time that the IVDR becomes fully applicable in the EEA and Northern Ireland on 26 May 2022. However, the transitional provisions in the draft Implementing Regulation together with the amended transitional provisions in the IVDR mean manufacturers will not need to apply the new common specifications immediately. The Implementing Regulation as drafted would only fully apply two years after it comes into force. Before it fully applies, IVDs that comply with the relevant common specifications adopted under the IVD Directive 1998/79/EC (“IVDD”), where they exist for the product type, will be presumed to be in conformity with relevant general safety and performance requirements under the IVDR.
Under the amended transitional provisions of the IVDR, IVDs that are classified as Class D under the IVDR that have been lawfully placed on the market in accordance with the IVDD before 26 May 2022 may continue to be placed on the market until 26 May 2025 (or, in the case of IVDs that required a Notified Body certificate as part of their conformity assessment process under the IVDD, the expiry of that certificate).
Manufacturers of legacy devices that relied on the old common specifications for their conformity assessment under the IVDD should consider how any differences in the new common specifications may impact their conformity assessment processes under the IVDR and may need to consider adjustments to their IVDR transition plans.