The Regulatory Framework in Switzerland – Ordinances and CH-REPs
Switzerland, though not a member state of the European Union, worked under a mutual recognition agreement (MRA) from 01 June 2002. Fast forward 19 years and the mutual recognition between the 2 territories ended. The European Commission announced in May 2021 that the trade facilitating effects of the MRA ceased overnight.
So, what has happened since May 2021? and how does this impact manufacturers?
New Regulations in Switzerland
As previously reported Switzerland has now introduced new medical device legislation. In May 2021, SR 812.213 Medical Device Ordinance (MedDO) is published, and in May 2022, SR 812.219 IVD Ordinance (IvDO) is published.
Both are a transposition of the MDR and IVDR respectively with some key differences:
Swiss Authorised Representative
If a manufacturer supplies IVDs or medical devices in Switzerland but is located outside the country, a Swiss Authorised Representative (CH-REP) is now required.
The CH-REP, similar to the EU Authorised Representative (EUAR) and UK Responsible Person (UKRP) is required to represent the manufacturer in the country and ensure that the products placed on the market have performed the appropriate conformity assessment and have a vigilance reporting responsibility. They also are to be “identified”, not necessarily on the product at this stage, on the delivery note is acceptable, except for devices for self-testing. This reduces the need for label changes of products.
However, unlike the EUAR and the UKRP, the CH-REP is not required to keep a permanent copy of the technical file, as long as a contract exists to ensure that it will be provided to Swiss Medic, the Swiss Competent Authority (CA).
Person Responsible For Regulatory Compliance (PRRC)
The PRRC is a role written into the MDR and IVDR and is now well understood. In Europe specific guidance is provided by the Medical Device Coordination Group (MDCG), MDCG 2019-7. In Switzerland the PRRC role is now a requirement, though there are some key differences. It is an explicit requirement that a deputy is also appointed and the PRRC does not have to be located within Switzerland and can be shared with the EUAR or the manufacturer.
Declaration of Conformity (DoC)
The DoC does not have to be a specific Swiss MedDO or IvDO declaration. A DoC drawn up under European legislation is acceptable.
Swiss Manufacturers, importers and CH-REPs will need to register with the Swiss medical device database. Actor and device registrations are planned for 2023.
The language requirements for information supplied to patients and users are German, French, Swiss, and Italian.
In Summary, Switzerland is a key territory and market. It totals 3.6%1 of the total medical technology market in Europe, with Switzerland totaling 3.8%1 of the IVD market in Europe. Many of the requirements have been aligned with the MDR and IVDR in order to reduce the disruption to the industry, however, there are differences. Understanding of the developing situation is critical for the continued supply of healthcare products in Switzerland and key to manufacturers maintaining market access.
The European Medical Technology Industry In Figures, 2022, Med Tech Europe
Director of Consulting Services