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Regulatory Affairs News

11.04.2024

European Commission

A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:

 

SCHEER

The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:

  • the evaluation of possible alternatives for phthalates used in medical devices, including alternative materials, designs, or medical treatments,
  • the methodology for performing a benefit-risk assessment, justifying keeping the presence of CMR and endocrine-disrupting phthalates at percentages above 0.1% w/w.

 

Swissmedic

New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation

21.03.2024

EU-CH negotiations

Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:

Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.

 

European Commission

MDCG just published its MDCG guidance development plan for 2024

  • Amongst the new, long-awaited documents: updated Vigilance forms, extended guidance on PMS and Vigilance for IVDs, guidance on IVD borderline issues and even RUO (Research Use Only), and guidance on Master UDI-DI.
  • Also, extensive work on documents for notified bodies is expected in Q2 2024.
  • And, for software, a “targeted revision” of MDCG 2019-11 (relative to medical device software qualification and classification), FAQs on the interrelation of EU MDR/IVDR and the new AI Act, as well as new guidance on the legal status of app providers, all three due by Q4 2024, sound promising.
14.03.2024

European Commission

Published updates to Harmonised Standards (HS):

  • Implementing Decision (EU) 2024/815 on HS under the EU MDR with updates to:
    • EN 455-3:2023 (on single-use gloves),
    • EN ISO 10993-15:2023, EN ISO 10993-17:2023 and EN ISO 10993-18:2020 (on biological evaluation),
    • EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized devices),
    • EN ISO 17664-2:2023 (on reprocessing).
  • The consolidated HS list is now also available: Summary list EU MDR
  • Implementing Decision (EU) 2024/817 on HS under the IVDR with updates to:
    • EN ISO 11137-2:2015, EN ISO 11607-1:2020, and EN ISO 11607-2:2020 (relevant for sterilized IVDs)
  • The consolidated HS list is now also available: Summary list IVDR

 

MDCG 2024-3: Clinical Investigation Plan

  • Details provided about the content of the CIP
  • The template of CIP synopsis is provided in the Appendix

This MDCG guidance document was already generically referenced in revision 1 of MDCG 2021-6 issued in December 2023. Another generic reference concerns an MDCG guidance document on the Investigator’s Brochure, which is expected to be published soon.

 

Updates to the dashboard for Notified Body survey on certification and application (EU MDR/IVDR)

  • Average timeframe to sign a written agreement: 62% take less than 2 months
  • Time to reach a new Certificate: QMS 6-12 months, QMS + Product 13-18 months

 

European Parliament

Artificial Intelligence Act adopted as Regulation on 13-Mar-2024:

  • European Parliament officially approved the AI Act
  • is now subject to final lawyer-linguist check
  • will enter into force 20 days after its publication in the Official Journal, and be fully applicable 24 months after it enters into force

 

MedTech Europe

Position paper regarding the Industry perspective on the final AI Act published on 13-Mar-2024. Main requests:

  • Timely EC guidelines for the applicability of the AI Act to the medical technology sector, involving also key stakeholders (i.e. MDCG)
  • Support for the single conformity assessment and technical documentation
  • Clear pathway for clinical/performance evaluation. They express the concern that CE marking under the AI Regulation would be required before investigational devices or IVDs for performance studies can be used in pre-market studies under the EU MDR or IVDR.

 

Proposal for “One Substance, One Assessment” package published on 14-Mar-2024. Main aspects:

  • Concept of ‘One Substance, One Assessment’
  • Propose optimizing the package of legislations for OSOA
  • Consider the new role of ECHA, clarify the interface between REACH and RoHS (preventing regulatory overlaps)
11.04.2024

European Commission

A Study and a dashboard on the reprocessing and reuse of single-use-devices in the EU have been published:

 

SCHEER

The preliminary update of SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices has been published for public consultation. It describes:

  • the evaluation of possible alternatives for phthalates used in medical devices, including alternative materials, designs, or medical treatments,
  • the methodology for performing a benefit-risk assessment, justifying keeping the presence of CMR and endocrine-disrupting phthalates at percentages above 0.1% w/w.

 

Swissmedic

New version of Guidance document for Export Certificates with minor clarification amendment to section 4.6.2 on Devices according to applicable legislation

21.03.2024

EU-CH negotiations

Last week the Swiss Federal Council signed off the mandate to resume negotiations with the European Union on bilateral agreement. You can read more about this here:

Although it is not stated clearly, these negotiations aim to reach an agreement by the end of 2024. We estimate that the mandate may take 2-3 more years to be agreed or even disregarded, as Swiss politics are known to be extremely cautious and, even if there is a majority in the Swiss parliament, the proposed mandate will be subject to referendum. Our take from the resumed bilateral negotiations is that the requirement to appoint a SAR/CH-REP will be maintained at least in the mid-term.

 

European Commission

MDCG just published its MDCG guidance development plan for 2024

  • Amongst the new, long-awaited documents: updated Vigilance forms, extended guidance on PMS and Vigilance for IVDs, guidance on IVD borderline issues and even RUO (Research Use Only), and guidance on Master UDI-DI.
  • Also, extensive work on documents for notified bodies is expected in Q2 2024.
  • And, for software, a “targeted revision” of MDCG 2019-11 (relative to medical device software qualification and classification), FAQs on the interrelation of EU MDR/IVDR and the new AI Act, as well as new guidance on the legal status of app providers, all three due by Q4 2024, sound promising.

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