The Mutual Recognition Agreement (MRA) had been a pivotal instrument in fostering bilateral trade between Switzerland and the European Union (EU), effectively circumventing technical trade barriers. Unfortunately, this arrangement came to an end on May 26, 2021. Coinciding with this shift, Switzerland implemented significant changes to its medical device regulations. The revised Swissmedic Medical Device Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices (IVDO) were enacted on May 26, 2021, and May 26, 2022, respectively.
Under the newly established regulations, Article 51 of the Medical Device Ordinance (MedDO) and Article 44 of the In Vitro Diagnostic Devices (IVDO) mandate that foreign manufacturers located outside Switzerland, without a local business presence, must appoint a Swiss Authorized Representative (CH-REP) to facilitate medical device registration and market entry in Switzerland. This applies across all classes of medical devices, including active implantable medical devices and in-vitro diagnostic devices. The Swiss Authorized Representative takes on the responsibilities outlined in the MedDO and IVDO, ensuring compliance on behalf of the foreign manufacturer. Due to an active customs treaty between Liechtenstein and Switzerland, there is no requirement for Liechtenstein to appoint a Swiss Authorized Representative.
Any entity, individual, or organization with a registered office within Switzerland is eligible to act as a Swiss agent for foreign manufacturers. A formal written mandate must be established between the Swiss Authorized Representative and the manufacturer. This representative must then register with Swissmedic and obtain a Swiss Identification Number (CHRN).
Foreign manufacturers have the option to designate several Swiss Authorized Representatives for their array of devices. However, it's important to note that only one Swiss Authorized Representative is permissible for all devices within the same generic device group. Conversely, for distinct generic groups, the appointment of multiple Swiss Authorized Representatives is permissible.
In scenarios where a company assumes the roles of both an importer and a Swiss Authorized Representative, it becomes liable to fulfill the responsibilities of both positions. Consequently, the company must formally register as both an importer and a Swiss Authorized Representative, ultimately obtaining two Swiss Single Registration Numbers (CHRN).
Additionally, a Person Responsible for Regulatory Compliance (PRRC) within the Swiss Authorized Representative's organization is a requirement. The agent must uphold key responsibilities, including device registration, conformity verification, responding to Swissmedic inquiries, and conducting Post-Marketing Surveillance (PMS).
The Swiss Product Liability Act dictates that the Swiss Authorized Representative, alongside the manufacturer, shares legal liability for defective products. Both parties are required to maintain sufficient liability insurance coverage, and the liability of a Swiss Authorized Representative cannot be waived through contractual agreements.
Product labeling must include details of the Swiss Authorized Representative, particularly the name, registered address, and email address. While it is not obligatory to include this information in Instructions for Use (IFU) or other documents, the product packaging must bear the Swiss Authorized Representative's information along with the designated symbol.
Companies have the flexibility to change their Swiss Authorized Representative at their discretion, with the responsibility of notifying Swissmedic about the termination of services.
For in-depth guidance on the roles and responsibilities of the Swiss Authorized Representative, comprehensive information is available on the Swissmedic website. The key responsibilities include –
Represent the foreign manufacturer and comply with the MedDO/IVDO regulations for device registration.
Validate the declaration of conformity and technical documentation.
Confirm if the manufacturer has conducted the necessary conformity assessment procedures.
Maintain copies of Declarations of Conformity and certificates for a decade, and 15 years for implantable devices, after the last device enters the market.
Ensure the manufacturer complies with device registration obligations.
Preserve copies of technical documentation, declarations of conformity, certificates, as well as any amendments or supplements.
Furnish Swissmedic with essential information and documentation upon their request to demonstrate device conformity.
Transmit Swissmedic's requests for samples or device access and facilitate their acquisition.
Collaborate with Swissmedic on preventive, corrective, or Field Safety Corrective Actions (FSCA).
Promptly notify the manufacturer of any complaints and market reports.
Access technical documentation or contractually arrange for the manufacturer to submit it directly to Swissmedic within seven (07) days upon request.
Take responsibility for ensuring reports are submitted to Swissmedic.
Maintain records containing data on post-market surveillance, complaint registrations, non-conforming devices, recalls, and withdrawals, known as the "Complaints List."
While there is no strict mandate, Swissmedic anticipates Swiss Authorized Representatives to undertake Post-Marketing Surveillance activities and share the manufacturer's responsibilities. This requirement raises the need for established processes, implying that organizations serving as Swiss Authorized Representatives should possess a basic Quality Management System.
The introduction of mandatory Swiss Authorized Representatives ensures compliance and facilitates smooth medical device registration processes. In the world of medical devices and regulatory compliance, having a Swiss Authorized Agent by your side is more than just a requirement – it's a strategic advantage. Their expertise, local knowledge, and ability to navigate the intricate landscape of Swissmedic regulations can make all the difference between a successful market entry.
So, if you're looking to tap into the Swiss market or have existing operations that need seamless compliance management, don't hesitate. Make the smart move and partner with a Artixio today.
Ready to explore the benefits of partnering with a Swiss Authorized Agent? Contact us now to learn how our team of experts can simplify the complex regulatory landscape, facilitate your market access, and ensure compliance with Swissmedic regulations.
Take the first step towards successful market entry by getting in touch with us today!