News | Swiss Medtech

FDA is at least equally safe as CE

Expert Report «Comparison of regulatory systems regarding safety of medical devices from the USA and EU», Johner Institut Schweiz GmbH (22 August 2023)

30.08.23 News

No need to revise the TPA

Legal Assessment «Is a revision of the Therapeutic Products Act necessary to implement Motion 20.3211?», written by Prof. Dr. iur. Tomas Poledna, Poledna RC, Zurich and Dr. iur. Remus Muresan, Muresan Legal, Zurich (18 August 2023)

29.08.23 News

Whitepaper on the further development of MDR / IVDR

The two medtech associations, BVMed and VDGH, call for the elimination of recertification as well as fast-track procedures for innovations.

28.08.23 News

Swiss Accelerator – new call

Innosuisse is launching the second call for projects for the Swiss Accelerator. With this funding programme, Innosuisse is supporting innovation projects of SMEs and start-ups that have already entered the market.

17.08.23 News

Revised Data Protection Act – Are you ready?

On 1 September 2023, the revised Swiss Data Protection Act (DPA) and corresponding provisions for implementation will come into force – immediately and with no transitional period.

15.08.23 News

MDR Chaos is weakening innovation

«This is how innovation gets stifled,» says Iwan Märki, co-founder of Lausanne-based start-up Abionic.

11.08.23 News

Current situation in the hospitals

«We have rarely experienced such a situation in the past. We are faced with consistant short-ages of a wide variety of medical consumables,» says Daniel Borer, Head Physician of the Clinic for Anesthesiology at Winterthur Cantonal Hospital.

26.07.23 News

The exclusive focus on costs is outdated

This is what Damian Müller, member of the Council of States, says in an interview about challenges and possible solutions in the health care system.

19.07.23 News

Information from the EU Commission

The EU Commission has published a very helpful Q&A document on the extension of the MDR transitional period. It includes links to important additional documents:

30.06.23 News

Motion 20.3211

Swiss Medtech expects the Federal Council to implement the parliamentary mandate swiftly and efficiently.

16.06.23 News

Information from GOV.UK

The UK has updated its guidance on the new medical device regulations. The recognition of medical devices with CE marking will be extended well beyond 30 June 2023. Medical devices with a valid MDD/AIMDD declaration can be placed on the market until 30 June 2028, MDR compliant devices and all IVDs until 30 June 2030.

14.06.23 News

More Medtech at the Insel Campus

The Centre Suisse d’Electronique et de Microtechnique (CSEM) is planning to establish a new division at the Insel campus in Bern.