IVD Regulation Enters into Full Application
Today marks the date of the full application of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in the EU.
Though five years since it first came into force, there are still some key aspects that are not fully in place, which is why the regulation was amended in January 2022 and granted many existing IVDs a further three to five more years to transition to the new requirements. There is also much work still to be done by the European Commission to ensure there is sufficient infrastructure to support the new regulation, and in particular, the question of Notified Body capacity, alongside meaningful guidance for industry.
Nevertheless, today is a welcome step, and though this is an EU piece of legislation, companies in the UK looking to place IVDs on the EU market will have to comply with IVDR. In addition, CE-IVD remains, for the time being at least, a valid route to the UK market.
ABHI will continue to work with partners in Europe and elsewhere on the regulations and provide comments on key IVDR guidance documents. Publication of the MHRA formal response to the consultation is also said to be imminent. ABHI will then be able to assess how well UKCA marking for IVDs aligns with IVDR and how much further work is needed. We will of course keep you updated on such developments.
