Challenges Regarding MRA Update and their Impact
Switzerland and the EU have made a Mutual Recognition Agreement (MRA) between themselves. Before implementing EU MDR, this MRA governed mutual access of medical devices to the Swiss markets. Also, before MDR’s implementation, the Swiss Medical Device Ordinance (MedDO, SR 812.213) adopted MDD, AIMD, and IVDR completely. This allowed Switzerland to import CE-marked medical devices just like any other Member State or EFTA country.
But since the MDR has been implemented, there are high chances that this scenario might change. According to the EU, the present MRA does not cover the new MDR, and therefore, it needs to be updated. However, updating the existing MRA might not be possible until the conclusion of an Institutional Agreement (InstA), and this doesn’t look easy in the current political situation. If the existing MRA is not updated, the EU will view Switzerland as a “third country” under the MDR. Similarly, all EU/EFTA countries will be viewed as “third countries” under the Swiss legislation on medical devices.
Although Switzerland had already revised its legislation in 2020 to be aligned with MDR, this revised version is not yet enforced. According to this revised version of Swiss MedDO, manufacturers located outside Switzerland will require a Swiss Authorized Representative to sell their CE-marked devices in Switzerland.
This Swiss Authorized Representative will be required for:
- CE-marked medical devices under the new MDR
- Legacy devices.
What are the Legacy Devices?
These devices are CE-marked under the previous MDD or AIMD. They benefit from the transitional provisions in Article 120 of EU MDR.
Who is the Swiss Authorized Representative?
According to revised Swiss MedDO Article 4, paragraph 1(g), the Swiss Authorized Representative for a foreign medical device manufacturer is:
“any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance.”
This natural or legal person (based in Switzerland) starts representing the foreign medical device manufacturer before the Swiss Competent Authorities by accepting this mandate. In case of defective devices, this Swiss Authorized Representative will be held legally liable alongside the manufacturer.
Role and Duties of the Swiss Authorized Representative
MedDo versus EU MDR
The duties of the Swiss Authorized Representative are defined in Article 51 of the revised version of MedDo. This Article is similar to the EU MDR’s Article 11, which defines the role of European Authorized Representative.
What are the Duties of the Swiss Authorized Representative?
According to Article 51 of MedDo, the duties of Swiss Authorized Representative include the following:
Compliance with Registration Obligations
He will comply with registration obligations in Switzerland according to revised MedDo.
Conformity Assessment Procedure
He will verify that
- The Declaration of Conformity and Technical Documentation has been thoroughly drawn up
- The manufacturer has performed an appropriate conformity assessment procedure.
Compliance with MedDo’s Device Labeling Requirements
He will ensure that MedDo’ device labeling requirements have been met.
Ensuring the Availability of Required Documents
He will have a copy of the following:
- Technical Documentation
- EU Declaration of Conformity and, if applicable
- A copy of the relevant certificate. This will include any amendments and supplements at the disposal of the Swiss Competent Authority (Swissmedic). Depending on the type of device, the Representative will keep these documents for the retention period of 10 or 15 years.
Demonstration of Device’s Conformity
Upon the Competent Authority’s request, the Swiss Authorized Representative will provide all the information and documentation necessary for demonstrating the device’s conformity. This might be required in official Swiss languages, i.e., German, French, and Italian.
Access to the Device’s Samples
If the Competent Authority requests for the samples or wants to gain access to a device, the Swiss Authorized Representative will forward this request to the manufacturer. He will also ensure that the Competent Authority receives the samples or gets access to the device.
Cooperation with the Competent Authority
The Swiss Authorized Representative will cooperate with the Competent Authority. He will take any preventive or corrective action to either eliminate or at least mitigate the risks posed by the medical device.
Informing the Manufacturer about Complaints
He will immediately inform the manufacturer about complaints and reports from
- Healthcare professionals
- Users about any suspected incidents regarding the device for which he has been designated.
Termination of the Mandate
He can also terminate the manufacturer’s mandate if he acts against MedDo Obligations.
Manufacturer’s Obligations that cannot be Assigned to Swiss Authorized Representative
The manufacturer must fulfill some duties and obligations, and they cannot be assigned to the Swiss Authorized Representative. They include:
- Ensuring the device’s conformity
- Implementation of a compliant risk management system
- Performing clinical evaluations (including post-market clinical follow-up activities)
- Compiling and keeping the device technical documentation up-to-date
- Drawing up the EU Declaration of Conformity
- Implementation of manufacturer’s post-market monitoring system
- Assigning UDIs to the device and maintaining them
- Maintenance of the manufacturer’s Quality Management System,
- Establishment of any corrective action that can bring a non-conforming device into conformity.
Requirements Regarding Particulars of the Swiss Authorized Representative
Like the European Authorized Representative, the particulars of the Swiss Authorized Representative are required to be on the device labeling units intended to be imported and made available in Switzerland. These specific requirements are not mentioned in the current version of MedDO and are expected to be added in the new version.
Designation Process of the Swiss Authorized Representative
Under the revised version of Swiss MedDO, appointing a Swiss Authorized Representative is necessary. Therefore, foreign manufacturers willing to export their devices in the Swiss market should appoint a Swiss Authorized Representative as soon as possible. For this, they need to follow the given steps:
- Negotiation about the contract
- Establishing internal procedures in the manufacturer’s QMS to describe the communication process
- Agreeing on logistics so that the most appropriate means of information and document sharing can be ensured, and
- Implementation of Swiss Authorized Representative’s particulars as required.
Enquire Now for Authorized Representative Service for Switzerland
TS Q and E are offering their services to foreign manufacturers regarding the appointment of the Swiss Authorized Representative. If you are a foreign device manufacturer, we can help you meet all the criteria set by Swiss MedDO in appointing the Swiss Authorized Representative. Thus, you will be able to export your CE-marked devices into Switzerland.