At the behest of Dr Peter Liese, MEP, who was co-rapporteur for the Medical Device Regulation (MDR, 2017/745), the European Parliament has provided the European Commission with a blueprint for an MDR Amending Regulation which would bring about significant changes to the current legislation. The 40-page document apparently addresses six principal concerns, with proposals for…
On 21 June 2024, the Council of the European Union adopted its conclusions on the Future of the European Health Union, emphasising critical areas such as availability of medical technologies, digitalisation of health, and building more resilient health systems. In a press release issued the same day, MedTech Europe called on Member States to enact…
Over the last few months the following new notified body designations have been announced: MDR – AFNOR Certification, France MDR – MTIC InterCert, Italy MDR – Kiwa Belgelendirme Hizmetleri, Turkey There are now 48 notified bodies designated under the MDR and 12 under the IVDR. A full list of notified bodies designated under the device…
The UK Medicines and Health products Regulatory Agency (MHRA) has today published its ‘Statement of policy intent: international recognition of medical devices’. This policy is intended to allow medical device manufacturers to use device clearances in other regulatory jurisdictions to ease entry to the GB (England, Scotland, Wales) market by recognising other international regulators’ approvals…
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its strategic approach to artificial intelligence (AI) in a new publication, available from here. Following publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, in 2023, the MHRA reports it has “taken significant steps in the past 12 months to…
After years of trying, the US Food and Drug Administration (FDA) has released its plan to bring laboratory developed tests (LDTs) under its regulatory control over the next few years. The much-anticipated final rule amends the agency’s regulations to treat in vitro diagnostic (IVD) tests made by laboratories as medical devices and offers a phased…
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…
