July 21, 2020
The Swiss Federal Council has approved a thorough revision of the Medical Devices Ordinance (MedDO), along with the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD). (The ordinances are abbreviated as MepV and KlinV-Mep respectively in the German documents linked here.) Both will take effect on May 26, 2021 to align with the EU Medical Devices Regulation (MDR) application date.
The version of MedDO currently in force integrates the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD), and the In Vitro Diagnostic Medical Devices Directive (IVDD). Equivalence of relevant legal requirements is a prerequisite for the Mutual Recognition Agreement (MRA) between Switzerland and the EU that includes Switzerland in the EU internal market for medical devices. The Federal Office of Public Health therefore announced in 2018 its intention to revise MedDO to match MDR and safeguard Switzerland’s continuing market participation.
Amendment allows market access without conformity assessment under certain circumstances
An amendment to MedDO has been approved as well and will become effective on August 1, 2020. This amendment establishes derogation procedures or exemptions for placing medical devices on the market that did not undergo relevant conformity assessment procedures when:
- the device is used for life-threatening conditions or the impairment of a body function;
- no equivalent device meeting conformity is available in the market; and
- the device is used by medical personnel on a patient who has been duly informed of the lack of conformity and associated risks and has agreed to treatment.
Legislation to harmonize Swiss regulatory system with IVDR is forthcoming
Still to come is a further regulation governing in vitro diagnostic devices (IVDs), which will be harmonized with the entry into force of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). That date so far is still set for May 26, 2022, and consultation on the legislation is scheduled for summer 2021. If IVDR implementation ends up being pushed back another year, the Swiss legislation will most likely follow suit.
More resources for medical device market access in the integrated EU medical device market:
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