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 – CAMD Statement – 50th CAMD Plenary meeting
In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to...
UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Switzerland – Dealing with certification gaps (MDCG 2022-18)
Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...
Europe – In vitro diagnostic device regulation in Europe: Update on revisions
The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework...
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 – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
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 – 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 – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays...
