Medical devices are regulated by: the Swiss Agency for Therapeutic Product
- Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance.
- Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR.
- Keep technical documentation, declaration of conformity & any other certificates updated.
- At the request of a competent authority, the manufacturer should submit the technical documentation as per List Annexes II and III EU-MDR.
- Manufacturers must have at least one person in their organisation responsible for compliance with the regulations.
- A manufacturer based outside Switzerland must appoint an authorised representative.
- EUDAMED Registration, UDI
Mutual recognition agreement (MRA) between EU and Switzerland: Possible situations
MRA updated before 26th May 2021
Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still need to appoint EU AR or Swiss AR.
MRA updated after 26th May 2021
This situation will require manufacturers from the EU and outside of the EU to appoint a Swiss AR. Between 26th May 2021 and the MRA update, Switzerland will be considered a third country for the EU during the transition period. MedDo will need to get updated suitable to the situation. Depending on the MRA status between the EU and Switzerland and the manufacturer’s location, the manufacturer has to decide if they should appoint a Swiss AR.
Swiss Authorised Representative
- A Swiss authorized representative(Swiss AR) is a legal person appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market.
- A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory.
- The manufacturer can appoint only a single Authorised representative in Switzerland.
- According to the Swiss ordinance on medical devices, the authorized representative is responsible for any product defects. AR is jointly and severally liable for product defects with the manufacturer.
Role of Authorised Representative
- Verify that the declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for the period.
- Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
- In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the member state concerned.
- Forward to the manufacturer any request by a competent authority of the member state in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation.
Registration in EUDAMED
- Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement.
- The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.
- Register at here: https://webgate.ec.europa.eu/eudamed/landing-page#/
- EUDAMED is structured around 6 interconnected electronic systems and a public website:
❑ Actors registration (Economic Operators)
❑ UDI/Devices registration
❑ Notified Bodies and Certificates
❑ Clinical Investigations and performance studies
❑ Vigilance and post-market surveillance
❑ Market Surveillance
Information in EUDAMED
Depending on the applicable directive, Eudamed2 contains data
a) On registration of manufacturers, authorised representatives, and devices
b) Declaration of conformity
c) Justification of the classification according to annex IX
d) A copy of the ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended,
withdrawn, or refused
f) Obtained in accordance with the Medical DeviceVigilance System
g) Information on clinical investigations
- The product information includes the labelling and the instructions for use.
- Must be written in the three official languages German, French, and Italian.
- Users are provided with additional information on request to be submitted in one of the official languages.
- The notice for products exclusively for demonstration and exhibition purposes should be present.
- Misleading or contradicting information about the intended use, safety and performance of a product is prohibited.
The latest update for Manufacturers in the EU & Swiss
EU Manufacturer exporting to Swiss: Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements
Timeline to appoint Swiss AR:
Swiss Manufacturer Exporting to EU:
- For MDR regulated devices & class I devices: Follow third country requirements from 26th May 2021.
- For MDD certified devices: No third country requirements, they will be regulated under MRA, free access to EU market as before until May 2024.
These requirements are subject to change depending on the MRA between the EU and Switzerland.
How we assist you with this process?
- Act as your Swiss Authorised Representative
- MedDO compliance
- EUDAMED registration
- Product information translations in German, French, Italian language
- EU MDR, IVDR gap analysis