Europe – Transition to MDR underway for 63% of outgoing Directives certificates
The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified...
Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU...
UK – Extension of CE certificates
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new...
Europe – Questions and Answers: Commission proposes an extension of the transitional periods for...
The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the...
Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
Europe – Le règlement (UE) 2023/607
Le règlement (UE) 2023/607, publié au JOUE, modifie les dispositions transitoires relatives à certains dispositifs médicaux et à certains dispositifs médicaux de diagnostic in...
Europe – Publication of the Third Edition of the “Clinical Evidence Requirements under EU...
We are pleased to announce the publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook.
The Questions and Answers eBook was developed by...
Europe – European Regulators Move to Increase Notified Body Capacity
The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical...
Europe – Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals
A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence...
Europe – Council votes unanimously to extend MDR deadlines
The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to...
