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MHRA publishes ‘Statement of policy intent: international recognition of medical devices’

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…

May 21, 2024
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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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Maria Donawa interviewed by MEDTECH INSIGHT

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…

April 12, 2024
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Maria Donawa posts article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘CEPs: Parameters vs outcome parameters, what’s the difference?’ The topic arises because of confusion among manufacturers, notified bodies, and competent authorities regarding the interpretation of certain requirements of the EU Medical Device Regulation (MDR, 2017/745) for clinical evaluation plans…

April 3, 2024
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