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MHRA publishes its strategic approach to AI

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…

April 30, 2024
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FDA issues long-awaited LDT final rule

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…

April 30, 2024
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European Parliament votes to amend IVDR and MDR

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…

April 27, 2024
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MDCG releases new and updated guidance documents

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…

April 19, 2024
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Commission publishes report on reprocessing of SUDs

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…

April 15, 2024
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Notified Body Update

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…

April 13, 2024
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Phthalates SCHEER guidelines update proposal published

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…

April 13, 2024
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Four opinions issued by expert panels July22-June23

The European Commission has recently published its annual report on devices subject to the clinical evaluation consultation procedure (CECP), available from here. Titled ‘Commission Staff Working Document: Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (July 2022-June 2023)’, the report identifies…

April 3, 2024
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Many more MDR/IVDR guidance documents on their way in 2024

MDCG has published its updated schedule for MDR/IVDR guidance documents, revealing that more than 50 are scheduled to be released before the end of 2024. Copies are available from this web address.

March 28, 2024
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IMDRF releases Outcome Statement from March Washington Meeting

The International Medical Device Regulators Forum (IMDRF) has now released the ‘Outcome Statement’ from its latest meeting, held 11-15 March 2024 in Washington DC, USA. Copies of the report are available from here, which include a note of the decisions made by the ‘regulators only’ closed session, during which eight revised guidance documents were approved…

March 22, 2024
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