Numerous articles report on the challenges for medical device manufacturers resulting from the cancellation of negotiations on a framework agreement between Switzerland and the European Union (EU). Often, only the perspective of manufacturers within the EU who want to market their products in Switzerland is considered. A popular keyword here is, for example, the Swiss authorised representative, whose role is now coming into play for EU manufacturers. However, this article is specifically aimed at manufactures located in Switzerland who want to market their products in the EU and introduces qtec as a possible partner who can support in this regard.
Until now, medical device manufacturers located in Switzerland could place their products on the EU internal market without restrictions. This applied to products for which a conformity assessment procedure had been carried out in accordance with the requirements of Directive 93/42/EEC (MDD). The Mutual Recognition Agreement (MRA) between Switzerland and the EU ensured this mutual recognition of conformity assessments.
With the date of application of the new Regulation EU 2017/745 (MDR) on May 26th, 2021, a renewal of the MRA should also have taken place. The update of the MRA is linked to the conclusion of an Institutional Framework Agreement (InstA). However, for the InstA, negotiations between Switzerland and EU were cancelled, so mutual recognition of conformity assessments and registrations of medical devices no longer applies. Switzerland is now classified as a third country. Additionally, without updating the MRA, Switzerland will be denied access to the central European database for medical devices (EUDAMED). Thus, Switzerland is not included in the exchange of information on registrations, product data or market surveillance activities.
To be able to continue to guarantee the supply of safe medical devices in Switzerland and to compensate for the lack of access to information on EUDAMED, the Swiss Federal Council adopted an amending decree to the Swiss Medical Device Ordinance (MedDO/MepV) in May 2021. These changes are strongly linked to the new MDR requirements and bring new challenges for medical device manufacturers, which now need to be implemented.
With the discontinuation of a valid MRA between Switzerland and the EU, Switzerland is considered a third country. Swiss manufacturers who want to place their products on the market in the EU’s internal market will now be treated in the same way as manufacturers from a third country and must meet the corresponding requirements.
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A new requirement is now to seek and nominate an authorised representative in accordance with Article 2 (32) and Article 11 of the MDR. This EU authorised representative must be established within the EU. A manufacturer may appoint several authorised representatives for different products, but one authorised representative must be appointed at least for all products in a generic product group. The authorised representative becomes the first point of contact for authorities within the EU and serves as the communication interface between the manufacturer and the authority. He checks whether an appropriate conformity assessment procedure has been carried out in accordance with the MDR. Furthermore, he checks that technical documentation has been prepared for the products and that a currently valid EU declaration of conformity is available. The authorised representative must be provided with a current copy of both by the manufacturer so that he can fulfil his obligation to possibly hand over the device to the competent authority.
In addition, the authorised representative shall verify compliance with the manufacturer's registration requirements referred to in Articles 27 and 29. He shall cooperate with the competent authority in any preventive or corrective action and immediately inform the manufacturer of any complaints or suspected incidents concerning the device.
The exact tasks of the authorised representative must be set out in a mandate, which must be accepted in writing by the authorised representative. At the request of the competent authority, the authorised representative is obliged to hand over a copy of this mandate.
An important task of the manufacturer is to adapt the labelling of his medical devices with another symbol from EN ISO 15223-1. The authorised representative must be clearly identifiable and marked on the product, for which the following independent symbol exists.
In addition to the labelling on the product itself, the manufacturer must indicate his authorised representative with name, address, and his Single Registration Number (SRN) on the EU declaration of conformity.
There are therefore many important interfaces between a manufacturer and his authorised representative. Since the manufacturer must provide his authorised representative with some of his documentation, such as the technical documentation of his medical device, it is important for the manufacturer to find a suitable authorised representative as a trustworthy partner.
In addition to the authorised representative, Swiss manufacturers now also require an importer in accordance with Article 2 (33) and Article 13 of the MDR to be able to introduce their products into the EU market. The importer is then considered to be the person placing the medical device on the market. The importer must also be located within the EU and registered in EUDAMED. Importers must be listed with their name and address on the product itself or on its packaging or on a document enclosed with the product. The importer also has control obligations such as verifying that the medical device to be imported is labelled MDR compliant incl. the CE marking and that an EU declaration of conformity has been issued. He must always have access to the currently valid instructions for use of the product. In addition, the importer must verify that the manufacturer has appointed an EU authorised representative and that a Unique Device Identification (UDI) has been assigned to the product for product identification in accordance with Article 27 of the MDR.
The importer serves as the communication interface between the manufacturer, the distributor or end-user and the competent authorities in cases of complaints from the market, vigilance notifications or non-conformities of the product with respect to the MDR requirements.
To meet these requirements, it is necessary for the Swiss manufacturer to find a suitable partner as importer and to coordinate the responsibilities and interfaces with this partner and record them in writing. Only in this way can a smooth placing on the market in the EU be guaranteed.
In order to be able to distribute his medical devices in the EU internal market, the Swiss manufacturer must implement further requirements in addition to establishing the new economic operators. He must register all economic operators and products in EUDAMED in accordance with Articles 29 and 31 of the MDR. The products must be clearly identifiable via the UDI in accordance with Article 27 of the MDR.
The manufacturer must carry out an appropriate conformity assessment procedure for its medical devices in accordance with Article 52 of the MDR and issue an EU declaration of conformity (DoC).
In his organization, he must have access to a Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of the MDR. This person must have the appropriate expertise and is responsible, among other things, for checking the conformity of the products, creating, and updating the technical documentation incl. EU declaration of conformity, fulfilling the post-market surveillance obligations and the reporting obligations in vigilance cases.
Furthermore, the manufacturer requires a post-market surveillance (PMS) system in accordance with Articles 83-86 of the MDR. This system contributes to the quality, safety, and performance of the medical device by systematically and actively identifying undesirable side effects, risks, product defects and use errors at an early stage.
For serious incident reporting, field safety corrective actions, and trending, the manufacturer needs appropriate processes to meet the vigilance requirements of Articles 87-92 of the MDR.
The disagreement between Switzerland and the EU and the resulting lack of updates to the MRA brings new additional challenges for medical device manufacturers. Manufacturers located in the EU as well as those located in Switzerland are affected and must react to the new requirements to continue to ensure the availability of their products on the respective markets.
As a partner of medical device manufacturers, qtec is happy to support you with questions concerning this topic. With the qtec EuRep GmbH, we can also assume the function of an EU authorised representative in accordance with Article 11 of the MDR for manufacturers based outside the EU. The qtec EuRep GmbH is already registered in EUDAMED with the SRN DE-AR-000005327. In the role as an EU authorised representative, we assume the following tasks, among others:
As a strategic partner, qtec ensures that manufacturers based outside the EU can start or continue marketing medical devices in the EU, considering the currently applicable requirements under the MDR.
Anforderungen an Schweizer Medizinproduktehersteller für den EU-Markt