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 an...

The European Commission (EC) should act in the “best interest of citizens” and establish a transition period to allow manufacturers to keep placing medical devices certified by a UK Notified Body (NB) on the EU market under a no-deal Brexit, trade association COCIR urged Wednesday in an open letter. The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry—otherwise known as COCIR—expressed its concerns around the increasingly lik...

Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU without reaching an agreement by the end of this month. The guidance, posted Monday, describes the steps applicants and sponsors need to follow for access to the new MHRA gateway for UK submissions from day one post-Brexit in a no-de...

With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions. From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requiremen...

The European Medicines Agency (EMA) urged marketing authorization holders (MAHs) looking to make Brexit-related changes in March to do so “as early as possible during the month,” citing a 50% expected increase in the number of marketing authorization changes over the next three months. EMA’s notice—posted on Tuesday—calls on MAHs that intend to submit Brexit-related Type IA and Type IB variations next month to do so well before the 29 March deadline for Britain to leave...

Nearly half (46%) of surveyed notified bodies (NBs) recently indicated that they do not intend to apply for designation under the European in vitro diagnostic regulation (IVDR), adding fuel to the contentious issue over the anticipated lack of NB availability to support industry demand. Team-NB, the European association for medical devices of NBs, conducted the survey “following interest form the sector concerning the designation process in the framework of the IVDR r...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a “no-deal” scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. It was developed based on responses to MHRA’s Octob...

UK health minister Jeremy Hunt and business minister Greg Clark on Monday wrote a letter to the Financial Times calling for the UK to continue working with the European Medicines Agency after Brexit. According to the Times , the letter said : "we want deep, broad and dynamic co-operation, and in this context the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety." The move was widely praised by U...