Following the government’s decision to extend the CE mark recognition for a wide range of…
MDR national implementation: Spain
The Spanish Agency on medical devices (AEMPS) published on March 21, 2023, its national law implementing the…
Updated Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has issued an updated document on their survey conducted among Notified Bodies on…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers…
MDR: 39th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR! HTCert (Health Technology Certification…
MDR & IVDR: New harmonised standards
On 5 July 2023, the Official Journal of the European Union published two new harmonised…
PSUR under MDR: When it’s necessary, and what are the deadlines?
As part of the efforts to establish a more consistent and systematic review of post-market…
Annex XVI MDR: new legacy period for devices without an intended medical purpose
Today, 21 June 2023, the Official Journal of the European Union published the final text…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations…