The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a So far, only five standards have been published in the Official Journal of the EU in the context of the EU’s Medical Device Regulation, and four in the context of the IVD Regulation.

But more standards are due to be officially published this year, including the European versions of the international quality system standard EN ISO 13485 and of the risk management standard EN IS0 14971, standards that are the very foundation of the implementation of the MDR and IVDR but which are now going to be officially available later than the originally anticipated October deadline.