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)...
UK – Medical devices – extended acceptance of CE marked medical devices on the...
A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great...
UK – MHRA : Implementation of the Future Regulations
The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
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...
