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...
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...
