On 25 April 2024, the European Parliament voted to adopt the Commission’s proposal to amend the In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746) and the Medical Device Regulation (MDR, 2017/745). There are three provisions in the amendments: The IVDR transition timescale is conditionally extended by two and a half years. This will help to…
The European Medical Device Coordination Group (MDCG) has release several new or updated guidance documents over the past few weeks, including: MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) Overview of language requirements for manufacturers of medical devices (March 2024) MDCG 2024-4 – Safety…
The European Commission has published its Final Report following the ‘Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market.’ The authors comment that: “This report presents an overview of national decisions regarding the reprocessing of SUDs [single use devices] in the countries studied (ranging from permitted…
TuV SUD Denmark becomes the 45th Notified Body to be designated under the MDR, and is the first from Denmark. This compares with there now being 12 Notified Bodies designated under the IVDR. The announcement for TuV SUD Denmark follows a few weeks after a second Swedish Notified Body was designated under the MDR, this…
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019. The proposed update was published on 21 March 2024 by the Commission and its Scientific…
Donawa Lifescience President, Maria E. Donawa, M.D., has been interviewed by Amanda Maxwell of MEDTECH INSIGHT on the subject of European medical device guidance document MDCG 2024-3 concerning clinical investigation plans in the journal dated 8 April 2024. The guidance, full title ‘Guidance on the content of the clinical investigation plan for clinical investigations of…
