"the transitional provisions were adopted by www.swissmedic.ch »
Ensuring equivalence to (EU) 2017/745 Medical Device Regulation MDR 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).
Manufacturers domiciled outside Switzerland must have mandated a Swiss authorised representative (all transition periods have expired).
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.
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.
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.
Contact us by email at ar@ch-rep.com
You will receive prompt feedback.