UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.
This...
USA – Switzerland eyes allowing FDA-approved medical devices onto its market
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators,...
Europe – TÜV SÜD Danmark ApS today received its designation as Notified Body 2443...
TÜV SÜD Danmark ApS today received its designation as Notified Body 2443 under Medical Device Regulation 2017/745 by the Danish Medicines Agency (DKMA). Notified...
UK – UK to strengthen regulation of medical devices to protect patients
MHRA to reform medical devices regulation to improve patient health and encourage innovation
The UK is seizing the opportunities provided by leaving the...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – Guidance on the procedural aspects for the consultation to the European Medicines...
This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural...
Europe – TUV NORD Polska New Notified Body Designated Under MDR
Notification of a Body in the framework of a technical harmonization directive...
Europe – European Commission approves updated regulation to ease contact lens UDI requirements
The European Commission has agreed to amend the EU Medical Device Regulation (MDR) to ease the Unique Device Identifier (UDI) requirements for certain products,...
