Switzerland Market Situation

• As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA)
• No barrier-free access to the EU internal market
• Swiss has been downgraded to the third country
• Swiss manufacturers have stricter requirements when exporting their medical devices to the EU.
• The Swiss MedTech industry will have:

1. The administrative cost of CHF 114 million initially
2. CHF 75 million annually
3. Cost represents 2% and 1.4% of total export volume (CHF 5.2 billion) to the
   EU

Switzerland Market Situation – Downside

• Non-EU manufacturers will not want to have an HQ based in Switzerland
• Swiss Start ups will move to the EU going forward for ease of trade
• Swiss has lost the advantage of an Economically important branch of industry with 63,000 employees and 1400 companies.

Switzerland- Medical Device Regulations

Medical devices are regulated by: the Swiss Agency for Therapeutic Product

Manufacturers Outside Swiss

• After 26 May 2021, foreign manufacturers must appoint a Swiss authorised representative in order to sell their devices in the market.
• An agreement between the manufacturer and the AR is needed.
• Who is a Swiss AR

– Proxy to the foreign manufacturer

– Responsible for product safety

– Liable for product defects

– contact person for Swiss authorities

– can be a legal entity or a natural person

– must have access to PRRC

Roles of Swiss AR’s PRRC

• Same as the role of PRRC for pharmaceutical products
• It is mandatory for an AR to appoint PPRC or delegate this to an external service provider
• Assumes a central role in PMS surveillance and in the control of medical devices
• He/she is personally responsible for the compliance with the duties incumbent on the AR and can be held criminally liable for the violation

Liability of a Swiss AR

• According to the swiss Product Liability Act, the manufacturer is responsible for any product defects.
• Swiss Ordinance on medical devices extends liability to Swiss AR
• AR is jointly and legally liable for any product defects.
• Liability of an AR cannot be waived by contract.
• AR and the manufacturer are obliged to take liability insurance with sufficient coverage.
• The manufacturer, however, may undertake to pay the insurance costs for the authorized representative.
• AR should do due diligence before signing the agreement with the manufacturer.

Manufacturer Responsibilities

• The centre of the responsibilities is defined by law.
• Prove and document conformity of his product, including correct classification.
• The introduction and maintenance of a QMS system is his responsibilities.
• AR is dependent on the manufacturer to fulfil its obligations.
• The manufacturer must be contractually obliged to guarantee the authorized representative full compliance with his legal duties.
• Legal duties include- CE mark, UDI, IFU, and Translation into Swiss languages.
• Manufacturers must supply the AR with extensive documentation.
• The manufacturer is obliged to retain the technical documentation, declaration, and certificate of conformity, including amendments and supplements for 10-15 yrs.
• AR to keep commercial records for 10 yrs.

Notifications

• Class I
• Custom made devices
• Systems and procedure packs
• Devitalised human tissue
• Repacked or relabeled medical devices
• Medical devices manufactured and used in health institutions in the Swiss
• IVD and self-testing IVDs, other IVDs
• IVD manufactured in house

UDI- CHRN

• The Swiss Single Registration Number (CHRN): Unique identification number
• Swissmedic assigns CHRN to Swiss manufacturers, authorized representatives and importers
• Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland.
• Registration with Swissmedic is necessary for CHRN
• Economic operators must register within three months of placing their first product on the Swiss market.

Update for Manufacturers in EU & Swiss

• Registration and notification obligations do not run via EUDAMED but via Swissmedic.
• Economic operators who have already placed products on the market before 26 May 2021 in accordance with the MDR and IVDR must complete their registration by 26 November 2021.
• Access to the technical documentation may be provided either by keeping a copy available at the authorised representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days.
• The validated Summary of Safety and Clinical Performance (SSCP) is not uploaded by the Notified Body in EUDAMED but published by the manufacturer, for example on its website.

For manufacturers outside Switzerland:

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.

How we assist you with this process?

• Act as your Swiss Authorised Representative
• MedDO Compliance
• Swissmedic Registrations & Notification
• Product Information Translations
• MedDO Gap Analysis