We simplify market access for medical devices

Swissmedic

Updated FSCA form (MU680_21_019, v.2.3), with the following changes:

• On page 1: added field to indicate the expected date of the next FSCA report.
• On page 5: grouped all options for actions to be taken on the same page (in the previous version, the option “None” was not readily visible).
• On page 6: improved the buttons to add and remove sub-actions.
• On page 7: in the list of countries affected, separated CH and LI, for clarity.
• On page 7: added the following line to the final statement “the FSN to be published complies with data protection regulations” (see below information on data protection).

Communication sent by Swissmedic to Swiss economic operators via e-mail on 25-Apr-2024 requesting that, for data protection purposes, Field Safety Notices (FSN) do not include:

• Personal data (e.g. names, personalized e-mail addresses, personal telephone numbers, signatures, etc.). Instead, generic e-mail addresses (e.g. info@company.com) or generic contact details (e.g. customer service) should be used.
• Customers’ details.

Swiss MedTech

Guidance on placing of “legacy” devices on the Swiss market after 26 May 2024 published on 25-Apr-2024. Intended for Swiss importers, distributors, and manufacturers, the guideline helps clarify that “legacy” devices CE-marked under the MDD/AIMDD that will not be transitioning to the EU MDR, can no longer be “placed on the market” after 26 May 2024. It also provides details on the risks for certain specific cases, like consignment warehouses or MDSW made available via online web shops.

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