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...
Europe – EMA official reports on scientific advice pilots for high-risk and orphan devices
A European Medicines Agency (EMA) official provided an update on the agency’s pilot programs aimed delivering scientific advice to manufacturers of high-risk and orphan...
Europe – Team-NB views on implementation of MDR/IVDR Regulations
At the Team-NB general assembly meeting, held on October 9th, the members aligned on a
strategy including operational aspects to respond to the concerns regarding...
Europe – Urgent need to revise the medical devices regulation
The European Parliament,
– having regard to the Treaty on the Functioning of the European Union, and in particular
Article 168 thereof,
– having regard to Regulation...
France – La HAS émet un avis favorable à l’octroi d’un forfait innovation pour...
Le diagnostic de l’endométriose peut s’avérer difficile lorsque l’examen clinique en 1re intention et le bilan d’imagerie en 2e intention produisent des résultats discordants. L’utilisation d’Endotest...
