Transitional Provisions In Vitro Diagnostics PRODUCTS

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

1. Legacy devices, in vitro diagnostics products

The new In Vitro Diagnostics Regulation IvDO of 04 May 2022 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 98/43 EEC may still be placed on the market or made available on the market after the IvDO comes into force if certain conditions are met.

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, 2022 and until the certificates expire, but not later than May 26, 2025.

Until May 26, 2026, 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:
- High-risk products (Class D): December 31, 2022
- Medium-risk products (Class B and C): March 31, 2023
- Low-risk products (Class A): July 31, 2023

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

For all other foreign manufacturers, there is an obligation to designate a Swiss
Authorized Representative as of May 26, 2022. These provisions apply to both IVD and
also for IVDR 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. In the case of products from abroad, the Swiss authorized representative and the Swiss importer must be indicated in accordance with the table below. Distributors have no obligation to indicate the address on the product or on a document accompanying the product. The indication of the economic operator includes the name and address of the registered office.

4. Information indicated for CH-REP

Klasse A (nicht für Eigenanwendung)

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class B

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class C

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class D

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Self-application

According to the defined transition periods (on the product packaging).

5. Information indicated for Swiss importer

Klasse A (nicht für Eigenanwendung)

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class B

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class C

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Class D

Be affixed to a document accompanying the product (delivery bill, pro forma invoice) by March 31, 2025.

Self-application

According to the defined transition periods (on the product packaging).

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