Key highlights of the revised Swiss Medical Device Ordinance

MedDO stands for Medical Device Ordinance and is a set of rules for medical devices introduced into the Swiss market. Earlier, Switzerland has taken over the European Union (EU) system of compliance assessment and certification, based on Mutual recognition agreements (MRA).Because Switzerland is a European country and not a member of European Union, a mutual recognition agreement (MRA) is required to facilitate the smooth movement (bilateral trade) of medical devices between these two markets.

After 20 years of smooth movement of medical devices between these two markets, the MRA ends as the directive no longer applies, and in order to align Swiss medical devices legislation to the new EU Medical Device Regulations MDR and IVDR, the MRA (Mutual Recognition Agreement) also needs to be updated so that barrier-free market access and joint surveillance can be ensured. However, the MRA could not be updated due to the failure of negotiations between Switzerland and the EU. As a result, Swiss Medic authority responsible for medical device regulation in Switzerland, has revised the Medical Device Ordinance (MedDO) and published the new Medical Device Ordinance for clinical trials (ClinOMD) in line with the latest EU-MDR regulations. Also, additional MRA will be needed for EU IVDR.

The latest changes to draft the MedDO are mostly due to the fact that Switzerland is considered as a “third country” for Europe (i.e., it will no longer participate in a common market for medical devices) and that the Swiss authorities will have no access to the European databases for medical devices.

Key changes of the revised MedDO are as follows:

Unique identification no. in accordance with Art. 55 MedDO

According to Article 55 of the MedDO, manufacturers, authorised representatives and importers of all medical devices, including systems and procedure packs (excluding custom-made products) that are placed in Swiss market require a unique identification number (CHRN – Swiss Single Registration Number).

Economic operators (manufacturers, importers, and authorised representatives based in Switzerland) must register with Swissmedic within the first three months of the device's introduction to the market. And, in accordance with MDR 2017/745 and IVDR 2017/746, economic operators who placed products before May 26th, 2021, must complete registrations by November 26th, 2021.

Manufacturer not based in Switzerland requires CHRep per Article 51

Article 51 of the revised MedDO specifies that any manufacturer not based in Switzerland may only place its products on the Swiss market when it has delegated a person based in Switzerland as its authorised representative (CHRep). This Swiss Authorized Representative will be required for both CE-marked medical devices under the new MDR and Legacy devices. Their rights and obligations are the same as those of EU authorized representatives according to Article 11 MDR. The authorised representative is responsible for the formal and safety-related aspects of placing the device on the market.

Importers may only place on the market devices that comply with this Ordinance per Article 53

Article 53 of revised MedDO specifies that importers may only place those devices in the market which complies with the MedDO requirements. Also, before placing the medical devices into the market importers need to verify that the devices must comply with the following requirements such as product labelling, conformity marking, DOC, UDI, CHRep etc. Importers must print their name, place of business and contact address on the product, the product packaging or a document enclosed with the product. Their obligations are the same as those of EU importers under Article 13 of the MDR.

Timeline to appoint Swiss Authorized Representative

Swiss Federal Government has decided to terminate negotiations on the EU-Swiss Institutional Agreement. As a direct consequence, the Mutual Recognition Agreement is not being updated, forcing Swiss companies to act as if from a third country and establish European Representatives in order to access the European market. The future reforms proposed by SwissMedic are designed to match Swiss medical device legislation with suitable European norms and rules to improve the overall safety and quality of medical devices marketed in Switzerland.