Switzerland to Model Medical Device Regulations on European MDR Requirements
EMERGO SUMMARY OF KEY POINTS:
- Swiss medical device market regulators are realigning their requirements to match those of the European MDR and IVDR.
- Switzerland is revising its Medical Devices Ordinance (MedDO) using a staged approach, with completed revisions planned for 2020.
The Swiss government plans to revise the country’s medical device legislation to align with the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR).
According to the Swiss Federal Office of Public Health (FOPH), the country’s Medical Devices Ordinance (MedDO) will undergo revisions to reflect MDR and IVDR requirements in the European Union. Although Switzerland is not an EU member, the country bases its medical device and IVD regulations on EU rules in order to maintain access to the broader European market.
Staged revisions to MedDO
Swiss regulators have timed changes to MedDO to coincide with MDR enforcement deadlines. The MedDO changes will occur in stages:
- In October 2017, Switzerland issued an early revision of the MedDO in order to support registration of Swiss conformity assessment bodies as Notified Bodies in Europe under the MDR.
- Consultations on proposed changes to the Swiss Therapeutic Products Act and Human Research Act are occurring in March 2018.
- Completed revisions to the MedDO as well as a new ordinance for IVD products will come into force in the first half of 2020.
- Adjustments to the Mutual Recognition Agreement between Switzerland and the EU establishing legal equivalence for medical device oversight must be negotiated, but no firm deadline has been identified for this stage.