Abrogation of the Mutual Recognition Agreement (MRA) for Medical Device – What are the new challenges for companies doing business in medical device area?
Author: Pragash Vijay, Regulatory Affairs Specialist
Mutual Recognition Agreement (MRA)
The negotiation to sign the EU-Switzerland Institutional Framework Agreement since 2014 has failed and the MRA fall into that. The MRA is a key player in the free movement of medical devices between Switzerland and EU. The actual MRA do not cover the new Medical Device Regulation (MDR) 2017/745 applicable from 26th May 2021 and an update is mandatory for its applicability. The absence of an update is a game changer for the following points:
- Bilateral Trade facilities
- “Single market access” and “Dynamic alignment”.
Until a potential consensus on the MRA modification is accepted. This ends the following benefits between both parties:
- Mutual Recognition of Conformity Assessment Results.
- Absence of the need for an Authorized Representative.
- Alignment of technical regulations.
Impacts of the abrogation of the MRA
In consequence, the import/export of medical devices is disturbed. Therefore, Switzerland has updated the Medical Device Ordinance (MedDO) to include the recognition of existing certificates from EU and transitional timeline for the new situation.
Concretely, the abrogation of the MRA lead to the following new requirements, resp. changes:
- Switzerland has now the status of a third country.
- Foreign companies who want to import medical device in our country shall designate an Swiss Authorized Representative (CH-REP) In the other hand, Swiss companies who wants to be involved in the EU market shall have an EU Authorized Representative (EC-REP).
- Manufacturers and the CH-REP must appoint a Person Responsible for Regulatory Compliance (PPRC).
- Notified Body established in Switzerland are no longer recognized by the EU. Swiss manufacturers must be assessed by an EU designated notified body.
- Transitional Timeline for EU manufacturers to designate a CH-REP.
- Labelling changes should be considered.
Person Responsible for Regulatory Compliance (PPRC) for CH-REP
The Person Responsible for Regulatory Compliance (PRRC) is required in both MDR 2017/745 (Article 15) and MedDO 812.213 (Article 52) for the Manufacturer and theAuthorized Representative.
The distributors in Switzerland can be designated as Authorized Representative (CH-REP) for EU manufacturers to comply with the new requirements and import products to Swiss market. This implies that “authorized representative shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possess the requisite expertise…”.
The role and responsibilities of the PRRC are various from Regulatory Affairs to Quality Management System (QMS) compliance as follow:
- Check of the Conformity of the device in accordance with the QMS.
- Maintaining Technical Documentation and Declaration of Conformity (DoC).
- Post-Market Surveillance & Vigilance obligations (FSCA / Trend Reporting).
- Establish a relationship of trust & Support with the Competent Authority.
To avoid any issue regarding the import/export of medical devices the Swiss authority has decided to put in place a transition phase. The deadline to designate a CH-REP is as follow:
- For Class III, IIb (implantable) and Active Implantable devices: until 31.12.2021
- For Class IIb (non-implantable) and IIa devices: until 31.03.2022
- For Class I devices: until 31.07.2022
Manufacturers or their CH-REP and the importer must register to Swissmedic within the 3 months after the first medical device was placed on the market.
The negotiation is still not over, and a better outcome can be expected. However, Swiss companies should act now and be ready.
Process Management System Sàrl (PMS), with his competent team specialized in regulatory and quality affairs in medical devices, can support any foreign companies, who wants to import medical device in Switzerland, or any distributors to ensure the role either as Swiss Authorized Representative (CH-REP), or as Person Responsible for Regulatory Compliance (PRRC).
For any question or if you need any support, do not hesitate to contact us at [email protected]
- European Commission – Press Release – Status of the EU-Switzerland: 26 May 2021
- European Commission – Notice to Stakeholders: Status of the EU-Switzerland MRA for Medical Devices: 26 May 2021
- Medical Device Regulation (MDR) 2017/745