Published on:
27. May 2021

MDR-News: Validity of certificates / Market approach in Switzerland and Turkey

As of today (2021-05-26), Regulation (EU) 2017/745 on medical devices (MDR) represents the applicable legal framework for medical devices. This is supplemented by national laws (e.g. in Germany the MPDG or in Austria the MPG 2021). However, Directive 93/42/EEC (

MDD) is no longer applicable and has been superseded by the MDR (see news article dated May 18, 2021).

mdc has already been designated as a Notified Body according to MDR since 2020-04-25; thus we can continue to offer our customers the necessary certification for market access for medical devices!

Certificates according to Directive 93/42/EEC remain valid – for the period of validity indicated on the certificate! In this context, we would like to remind you that for placing medical devices of class III on the market, both a valid certificate on the quality assurance system (e.g. according to Annex II, without Section 4 MDD) and a valid certificate on the product design (e.g. according to Annex II, Section 4 MDD) are required. A certificate according to MDR (e.g. about the quality management system according to Annex IX, chapter II MDR) is not a sufficient substitute.

For the maintenance of MDD certificates under the MDR we refer to the news article of 08.03.2021.

Market Approach:

According to the latest information the customs agreements with Turkey could be adjusted in due time. This means that Turkish manufacturers can also continue to participate in the European market.

Due to the start of validity, some trade agreements between the EU and other states lose their validity. For example, the Mutual Recognition Agreement with Switzerland has not been extended, and Switzerland is considered a third country. This means that Swiss manufacturers need a European authorized representative, and must also indicate this on the labeling. Likewise, EU manufacturers must indicate a Swiss authorized representative based in Switzerland for export to Switzerland.
However, no transition periods have been defined, so these requirements apply to all products that are placed on the market for the first time after DOA (i.e. 26.05.2021, 0:00).

Already at the beginning of 2021, the United Kingdom has left the European Union, with far-reaching consequences for the market access of British manufacturers in the EU (necessity of a European Authorized Representative) as well as with consequences for EU manufacturers for the British market access (UKCA marking, at the latest from 30.06.2023), see also our news article from 28.01.2021.