We simplify market access for medical devices

Swissmedic

Overhauled Swissmedic’s information sheet on Medical Device Software, significantly expanded from the previous version with:

• Important new section on Class I medical device software (MDSW), outlining possible MDSW functionality that would classify as Class I under the Swiss MedDO. This represents a shift in Swissmedic’s traditionally conservative approach to MDSW and places Swissmedic’s interpretation ahead of the expected review of EU’s MDCG 2019-11 planned for late 2024.
• Regulatory requirements in terms of General Safety & Performance Requirements (GSPRs), technical documentation, clinical/performance evaluation, and labelling & UDI, in alignment with the EU MDR/IVDR.
• Brief references to MDSW distance sales, economic operators obligations, and post-market obligations.
• Updated and clearer references to the legal framework in Switzerland, also pointing to EU legislation, MDCG guidelines, and potentially applicable standards.

European Commission

New MDCG documents published:

MDCG 2022-9 rev.1 Summary of Safety Performance template (for IVDs) update Rev. 1

• Clarification on when the SSP should be made available to patients

MDCG 2024-4 Safety reporting in performance studies (for IVDs)

• Reporting obligations of the sponsor due to adverse events
• Reporting method, types of events, and pathways

MDCG 2024-5 Investigator’s Brochure contents for clinical investigations

• Guidance provided on topics covered in EU MDR Annex XV, section 2.7
• Appendix A – cross-referencing Annex XV is separately published as Word doc.

European Commission

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

• Study on the implementation of Article 17 of EU MDR in the EU
• The Dashboard – presents an overview of the mapping activities

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

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:

• Swiss Federal Council’s press release
• European Council’s press release

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.