UK – Medical Devices Regulations: Routes to market and in vitro diagnostic devices
This consultation applies to medical devices in Great Britain. For guidance on the
regulation of devices in Northern Ireland, see Regulation of devices in Northern...
France – Implants et prothèses dentaires : avis favorable de la HAS pour leur...
Alors que le nombre de personnes concernées par la perte d’une voire de l’ensemble des dents est amené à croître, la pose d’implants n’est...
Europe – MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical...
Europe – Experts: Notified body survey shows MDR/IVDR progress despite some snags
A recent survey shows progress in the number of applications being filed with notified bodies (NB) and certificates issued under the EU Medical Device...
Europe – Q&A Obligation to inform in case of interruption or discontinuation of supply
Introduction – Objectives of the MDR/IVDR amendment
The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics:
1. Regulation (EU)...
USA – Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing:...
The Mitre Corporation says stakeholders should work together to normalize how software bill of materials (SBOMs) are implemented in a newly published white paper,...
Europe – Notified body official shares recommendations for successful PMCF plans
Successful postmarket clinical follow-up plans (PMCFs) should be able to provide new information that was not previously known about a device, such as delayed...
Europe – MDCG 2022 – 5 Rev. 1 Guidance on borderline between medical devices...
The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on
the one hand and the Directive 2001/83/EC on the Community code relating to...
Europe – MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the...
The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to...
UK – UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What...
On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s...
