CHE/237
WTO/TBT
CH Schweiz
  • 11 - Medizintechnik
2019-07-27
2019-06-14

Medical devices, except in vitro diagnostic medical devices

(1) Projet de révision totale de l'Ordonnance sur les dispositifs médicaux (ODim, RS 812.213) (Complete draft revision of the Medical Device Ordinance (ODim, RS 812.213)), 50 pages, available in French, German and Italian; (2) Projet de nouvelle Ordonnance sur les essais cliniques de dispositifs médicaux (Oclin-Dim) (Draft new Ordinance on clinical trials for medical devices (Oclin-Dim)), 29 pages, available in French, German and Italian.

Following various events involving medical devices, Europe has strengthened its regulations in this regard. Two regulations concerning conventional medical devices (Medical Devices Regulation, MDR[1]) and in vitro diagnostic medical devices (In vitro diagnostic medical devices regulation, IVDR[2]), respectively, entered into force on 26 May 2017. These texts will become fully applicable after various transition periods (up to three years for the MDR and up to five years for the IVDR). The MDR will become fully applicable on 26 May 2020. In order to improve the safety and quality of medical devices, Switzerland has adapted its legislation on medical devices in line with developments in European law. In light of the partial revision of the Law on Therapeutic Products (LPTh) and the Law on Research involving Human Beings (LRH), adopted by the Swiss Parliament on 22 March 2019, the present draft text provides for a full-scale reform of the right of enforcement, that is, a complete revision of the ODim and the establishment of a new Ordinance on clinical trials for medical devices (OClin-Dim). These Ordinances must enter into force at the same time as the legal amendments and at the moment when the EU law becomes applicable in the Member states (MDR: 26 May 2020).

The EU requirements on in vitro diagnostics will be incorporated into Swiss law at a later date, by means of a separate ordinance (entry into force in May 2022).

The main amendments are as follows:

·         Manufacturers must prove, through clinical studies, the benefits and appropriateness of high-risk products, and assess their safety.

·         The approval and monitoring criteria for clinical trials and performance tests have been strengthened.

·         Each device must have a unique device identification (IUD) number to allow for their unequivocal identification and guarantee full traceability.

·         Various data must be recorded in the European Database on Medical Devices (EUDAMED). Some of these data must be made available to the public in an understandable form.

·         The requirements to be met by the competent authorities and conformity assessment bodies, and their responsibilities, are regulated in a clearer and stricter manner. Furthermore, the new provisions address existing gaps.

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Official Journal L 117 of 5 May 2017, p. 1. [2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, Official Journal L 117 of 5 May 2017, p. 176.