Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations...
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by...
Europe – Votre avis sur l’extension de la période de transition des RDM et...
La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the...
MHRA is aware of a very small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule...
Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can...
In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
Europe – EUDAMED user guide : Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU
medical devices regulations:
Regulation 2017/745 on medical devices
Regulation 2017/746 on in vitro...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
Europe – MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on...
UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
