Transitional provisions for Medical Devices

«The Transitional requirements were taken over from www.swissmedic.ch»

1. Legacy devices

The new Medical Devices Ordinance MepV of 26 May 2021 applies in principle to all products. Certain products that comply with the previous law and were CE marked in accordance with the old MepV or Directive 93/42/EEC or Directive 90/385/EEC may still be placed or made available on the market after the MepV comes into force if certain conditions are met.

This exception applies to the following products:

- Class I devices with a declaration of compliance prior to May 26, 2021, for which certification (i.e., inclusion of a designated body) will be required under the new regulation (e.g., reusable surgical instruments, devices classified in a higher class under the MDR); or
- Devices with a valid certificate ("EC certificate") under the previous regulation.

Provided that these products comply with the relevant directive and there are no significant changes to their design and purpose, they can be placed on the market after May 26, 2021 and until the certificates expire, but not later than May 26, 2024.

Until May 26, 2025, they may continue to be provided in the distribution chain.

2. Designation of a CH REP

For manufacturers domiciled in an EU/EEA state or with an authorized representative in an EU/EEA state, the following deadlines apply for the mandating of a Swiss authorized representative:
- Products with high risks (Class III, IIb implantable and AIMD): December 31, 2021
- Products with medium risks (Class IIb non-implantable, Class IIa): March 31, 2022
- Products with low risks (Class I): July 31, 2022
- Systems and treatment units: July 31, 2022.

EEA states are the member states of the EU, Iceland, Norway and Liechtenstein. However, the deadlines only apply to EU states, Norway and Iceland. Due to the customs treaty between Liechtenstein and Switzerland, a manufacturer in Liechtenstein is not obliged to appoint an authorized representative in Switzerland. For all other foreign manufacturers, the obligation to appoint a Swiss authorized representative applies from May 26, 2021. These provisions apply to both MDD and MDR products.

For all other foreign manufacturers, there is an obligation to designate a Swiss
Authorised Representative from 26 May 2021. These requirements apply to both MDD, and
also for MDR products.

3. Identification of the Manufacturer, the CH-REP and the Importer.

The manufacturer of the product must be defined and indicated on the label in all cases and without exception. For products from abroad, the information of the CH-REP and the importer must be indicated on the label according to the table below. Distributors have no obligation to indicate the address on the product or on a document accompanying the product. The information for economic operators (the manufacturer, the Swiss Authorized Representative and importer) includes the name and the address of the registered office.

4. Information indicated for CH-REP

Deadline: from 26.05.2021, if applicable, after the deadlines stated in chapter Naming a CH-REP.

Where must the information be indicated:

Until 31.07.2023, the information must be indicated either on the label or in a document accompanying the device.

After 31.07.2023, the information must be indicated on the label.

Deadline: from 26.05.2021, if applicable, after the deadlines stated in chapter Naming a CH-REP.

Where must the information be indicated: The information must be indicated on the label

Deadline: After expiry of the deadlines stated in chapter Designation a CH-REP.

Where must the information be indicated:

On the label or in the instructions for use or on a document accompanying the product.

Deadline: from 26.05.2021

Where must the information be indicated:

On the label or in the instructions for use.

5. Information indicated for Swiss importer

Deadline: from 26.05.2021

Where must the identifier of the importer be placed: On the product or on the packaging or on a document accompanying the product.

Deadline: From 26.05.2021

Where must the identifier of the importer be placed: On the product or on the packaging or on a document accompanying the product.

Deadline: from 31.07.2022

Where must the identifier of the importer be placed: On the product or on the packaging or on a document accompanying the product.

Deadline: from 31.07.2022

Where must the identifier of the importer be placed: On the product or on the packaging or on a document accompanying the product.

Links:

Contact form:

Do you have questions?

We will contact you if you send us a message.

Contact us by email at ar@ch-rep.com 

You will receive prompt feedback.

What is a medical device?