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...
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 – 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...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle...
Alors que la crise du Covid-19 n’est toujours pas terminée, gardons à l’esprit la première leçon qu’elle nous a apprise : l’anticipation est la clé...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
