Transitional provisions for Medical Devices

"the transitional provisions were adopted by www.swissmedic.ch »

1. Legacy devices

Ensuring equivalence to (EU) 2017/745 Medical Device Regulation MDR in Switzerland

During the transitional phase, until the Medical Devices Ordinance (MDO) has been adapted, Swissmedic is already implementing enforcement in accordance with the EU amendment so as not to jeopardise the supply of medical devices in Switzerland.

In the EU, both an amendment to the (EU) 2017/745 MDR regarding the transitional periods for certificates and an amendment to the (EU) 2017/745 MDR regarding the discontinuation of the periods for placing in service and making available on the market were published on 20 March 2023. Thus, in view of the shortages of notified bodies, the EU has implemented, among other things, an extension of the validity of existing certificates until 2027/2028 (period depending on the classification) under certain conditions and the abolition of the deadlines for placing in service and making available on the market ((EU) 2017/745 MDR).

2. Designation of a CH REP

Manufacturers domiciled outside Switzerland must have mandated a Swiss authorised representative (all transition periods have expired).

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

The manufacturer of the product must be defined and indicated on the labelling in all cases and without exception. In the case of products from abroad, the CH-REP and the importer must be indicated in accordance with the following table. Distributors have no obligation to indicate the address on the product or on a document accompanying the product. The indication of economic operators includes the name and address of the registered place of business.

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: ab sofort (sämtliche Übergangsfristen sind abgelaufen).

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

Deadline: ab sofort (sämtliche Übergangsfristen sind abgelaufen).

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. Indication of the 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.

6. Unique Device Identification UDI

  • for medical devices according to MDR class I: from 26 May 2025
  • for medical devices according to MDR class IIa and IIb: as of 26 May 2023
  • for medical devices according to MDR class III and implants: Transition period expired since May 2021

  • Medical devices according to MDD can still be placed on the market without UDI.

    Medical devices in accordance with the MDR that were placed on the market in Switzerland before the end of the transition period can be made available on the market without a UDI.

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    Contact us by email at ar@ch-rep.com 

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    What is a medical device?