Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under...
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 and Answers on Certificates of Free Sale and Article 60 of...
This Questions and Answers document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale.
It...
Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system...
This document presents questions and answers on the Unique Device Identification system
(UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation...
Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...
Europe – MDCG raises alarm over lack of MDR, IVDR applications
The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...
UK – Three new UK Approved Bodies to certify medical devices announced by the...
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices...
Europe – Notified bodies’ paper on the application of hybrid audits to quality management...
Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
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 – New European Manual on Borderline and Classification for medical devices and IVDs...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
