Notified body (NB) availability and readiness for implementation of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) stand out among “burning points” in need of authorities’ attention, according to industry group MedTech Europe.
The group’s director of regulations and industrial policy, Oliver Bisazza, explained how time is running out on MDR/IVDR implementation, and not just because of the 2020/2022 deadlines, but also due to lack of progress and preparations.
The biggest issue facing industry as it relates to MDR/IVDR implementation is the “timely readiness of the new regulatory system,” said Bisazza, citing the incomplete work on implementing acts, guidance documents, expert panels, EU reference laboratories, high-risk IVDs’ common specifications and NBs.
A number of pending MDR/IVDR essential implementing acts and guidance documents were highlighted. The first in a series of forthcoming guidances from the European Medicines Agency (EMA) was issued late February. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also issued its own guidance to aid in compliance with MDR and IVDR under a no-deal Brexit scenario.
The UK’s guidance and legislation are also in need of updates to reflect the new Brexit date—12 April. Although Prime Minister Theresa May said Tuesday she’s pushing for a further extension.
The EU’s the Medical Device Coordination Group (MDCG), established by the regulations in 2017, has endorsed guidance documents covering certain topics, including unique device identification and the content of new products certificates, among others. The European Commission (EC) also endorsed MDCG’s document on the EU’s nomenclature last month…