Switzerland Medical Device Regulations

Switzerland Medical Device Regulations

by | Jun 10, 2021 | Regulation, Swiss AR

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
Switzerland Authorised Representative

Switzerland Authorised Representative

by | May 24, 2021 | Regulation, Swiss AR

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

Switzerland Medical Device Regulations - omcmedical.com

Manufacturer Responsibility

  • Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance.
  • Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR.
  • Keep technical documentation, declaration of conformity & any other certificates updated.
  • At the request of a competent authority, the manufacturer should submit the technical documentation as per List Annexes II and III EU-MDR.
  • Manufacturers must have at least one person in their organisation responsible for compliance with the regulations.
  • A manufacturer based outside Switzerland must appoint an authorised representative.
  • EUDAMED Registration, UDI

Mutual Recognition Agreement (MRA) between EU and Switzerland: Possible situations

  • MRA updated before 26th May 2021

Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still need to appoint EU AR or Swiss AR.

  • MRA updated after 26th May 2021

This situation will require manufacturers from the EU and outside of the EU to appoint a Swiss AR. Between 26th May 2021 and the MRA update, Switzerland will be considered a third country for the EU during the transition period. MedDo will need to get updated suitable to the situation. Depending on the MRA status between the EU and Switzerland and the manufacturer’s location, the manufacturer has to decide if they should appoint a Swiss AR.

Switzerland Authorised Representative

  • A Swiss authorized representative(Swiss AR) is a legal person appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market.
  • A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory.
  • The manufacturer can appoint only a single Authorised representative in Switzerland.
  • According to the Swiss ordinance on medical devices, the authorized representative is responsible for any product defects. AR is jointly and severally liable for product defects with the manufacturer.

Role of Authorised Representative

  • Verify that the declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for the period.
  • Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
  • In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the member state concerned.
  • Forward to the manufacturer any request by a competent authority of the member state in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
  • Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
  • Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation.

Registration in EUDAMED

  • Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement.
  • The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.
  • Register at here: https://webgate.ec.europa.eu/eudamed/landing-page#/
  • EUDAMED is structured around 6 interconnected electronic systems and a public website:

❑ Actors registration (Economic Operators)
❑ UDI/Devices registration
❑ Notified Bodies and Certificates
❑ Clinical Investigations and performance studies
❑ Vigilance and post-market surveillance
❑ Market Surveillance

Information in EUDAMED

Depending on the applicable directive, Eudamed2 contains data
a) On registration of manufacturers, authorised representatives, and devices
b) Declaration of conformity
c) Justification of the classification according to annex IX
d) A copy of the ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended,
withdrawn, or refused
f) Obtained in accordance with the Medical DeviceVigilance System
g) Information on clinical investigations

Product Information

  • The product information includes the labelling and the instructions for use.
  • Must be written in the three official languages German, French, and Italian.
  • Users are provided with additional information on request to be submitted in one of the official languages.
  • The notice for products exclusively for demonstration and exhibition purposes should be present.
  • Misleading or contradicting information about the intended use, safety and performance of a product is prohibited.

The latest update for Manufacturers in the EU & Swiss

EU Manufacturer exporting to Swiss: Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements

Timeline to appoint Swiss AR:

Manufacturers in EU & Swiss - omcmedical.com

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.

These requirements are subject to change depending on the MRA between the EU and Switzerland.

How we assist you with this process?

  • Act as your Swiss Authorised Representative
  • MedDO compliance
  • EUDAMED registration
  • Product information translations in German, French, Italian language
  • EU MDR, IVDR gap analysis