Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice from the MDCG on MDR compliance, a Q&A concerning the interface between clinical trials and IVDR, the EU’s recommendation for defining ‘nanomaterial’, the latest from the MHRA on future medical device regulation in the UK, as well as final guidance regarding quantitative imaging from the FDA and a call for input from Health Canada on proposed changes to recognised medical device standards. Read on for more…
EU Commission shares notice on status of EU-Swiss MRA for IVD medical devices
The new IVDR became applicable on 26 May 2022, replacing Directive 98/79/EC. Without an updated Mutual Recognition Agreement (MRA) that includes this new regulation, the part of the existing MRA chapter that covers in vitro diagnostic medical devices now ceases to apply.
As a result, there is no longer a mutual recognition of conformity assessment results, alignment of technical regulations, nor the absence of the need for an authorised representative.
The EU Commission’s recent notice outlines the consequences for stakeholders as of 26 May 2022 here.
MDCG urges timely compliance with MDR requirements
A recent position paper from the MDCG urges manufacturers to ensure timely compliance with MDR requirements. The paper refers to data provided by notified bodies in April 2022 that demonstrates the large volume of valid AIMDD / MDD certificates that will expire in 2023 – 2024, and the relatively small number of notified bodies designated under the MDR to manage them.
The MDCG advises that the transition period should not be perceived as a “grace period” to postpone the entering into application of the new rules – rather utilised to finalise MDR preparedness.
From 27 May 2024, the MDR will be fully applicable to all medical devices, yet as of April this year, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
Around 70% of AIMDD/MDD certificates will expire in 2024. Manufacturers should be aware that if they delay their application until the first months of 2024, it mightn’t be possible for notified bodies designated under the MDR to assess all corresponding files by the ultimate deadline of 26 May 2024.
To avoid medical device shortages, the advice for manufacturers is clear – adjust your system, finalise transition to the MDR, and submit complete and compliant applications to your notified body as soon as possible. Read more on this here.
MDCG shares Q&A on interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use and IVDR
The MDCG has published a Q&A to clarify certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 (IVDR).
MDCG 2022-10 was developed by clinical trials experts from the Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the MDCG. It has been adopted by CTFG, the Clinical Trials Expert Group of the European Commission and endorsed by the MDCG.
EU Commission publishes recommendation on definition of nanomaterial
The EU Commission has published their recommendation on the definition of nanomaterial. The Commission outlines that the term ‘nanomaterial’ refers to a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil certain conditions.
They advise that the definition of the term ‘nanomaterial’ set out in this latest recommendation is used by the Commission, Member States and economic operators when addressing materials or issues concerning products of nanotechnologies. Find out more here.
UK government publishes response to consultation on future medical device regulation
The UK government has published their response to the consultation on the future regulation of medical devices in the United Kingdom.
Having analysed the engaged responses to their consultation, the MHRA and UK Secretary of State for Health and Social Care Sajid Javid have shared that the UK’s “world-leading medical device regulatory framework” will be built on five pillars:
- Strengthening MHRA power to act to keep patients safe
- Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards
- Setting world leading standards – building the UKCA mark as a global exemplar
FDA releases final guidance on technical performance assessment of quantitative imaging
The FDA has released final guidance that provides their recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions.
The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions. You can download the final guidance here.
Health Canada seeks input on proposed changes to recognised standards for medical devices
Health Canada is proposing changes to the Medical Devices Directorate’s (MDD) List of Recognised Standards for medical devices, and is seeking input from medical device manufacturers, healthcare professionals and interested public parties to complete the annual update.
The proposed changes include adding 29 new standards, replacing previous editions with 41 new editions of currently recognised standards, and removing one standard.
The consultation opened on 24 June 2022 and will close to new input on 23 August 2022. Find out more here.
That concludes our June MedTech news. Check back in July for more updates.
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