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EU-Turkey customs union agreement under MDR and IVDR is now official

On the 13thApril 2022 the European Commission released a note that provides important updates in the field of medical devices and in vitro-diagnostic medical devices.

This note announces the renewal of the Customs Union joint agreement between Europe and Turkey also under Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

On the 26thMay 2021 the Commission had already release a note addressed to the medical Device Coordination Group (MDCG) confirming the conclusion of the agreement with Turkey for MDR and anticipating an oncoming agreement on the same basis also for IVDR.

With the note released in these days both agreements are now official, with an important regulatory impact for both medical devices and in-vitro diagnostic medical devices.

The customs union agreement in the field of medical devices

Turkey, in the context of a customs union with EU, had already autonomously comform to the provisions of the three devices in the field of medical devices, meaning the Dir. 93/42/EEC, Dir. 98/79/EC and Dir. 90/385/EC.

The ЕС-Turkey Association Council formally acknowledged it through the Decisions n°1/95, 2/97 and 1/2006, basically implementing the last step to achieve the Customs union.

Furthermore, with the declarations of the Joint EU-Turkey Customs Union Committee of 21st May and 13th September 2021, it has been made clear that what was established with the Decision 1/2006 should also apply to products compliant to MDR or IVDR.

The effects of the agreement

What was the agreement implying and what does it imply today regulatory wise?

Looking at a label of a medical devices with turkish legal manufacturer, we can see how most of the times no european authorized representative appears.

This is due to the fact that the turkish manufacturers have no legal obligation to designate an EU-based authorized representative. The basis for this facilitation have been laid down through art. 9 of the Decision 1/95:

“When Turkey has put into force the provisions of the Community instrument or instruments necessary for the elimination of technical barriers to trade in a particular product, trade in that product between the Parties shall take place in accordance with the conditions laid down by those instruments”

Those instruments are listed in the Annex II of the Decision 2/97 and the medical devices directives are in fact mentioned. Today MDR and IVDR do appear among those instruments, since they have been included in the decision 1/2006 in the course of 2021.

In addition, Annex I of Decision 2/97 indicates that the territorial references must be interpreted as follows:

“Whenever the instruments referred to contain references to the territory of the ‘Community` or of ‘the common market` the references shall for the purposes of Decision No 1/95 be understood to include the territory of the Turkish Republic.”

Since Turkey is considered part of the single market, it is possible for an extra-EU manufacturer to choose whether to designate an authorized representative in Europe or Turkey, as specified in Decision 1/2006.

In addition, Turkey is entitled to designate Notified Bodies under the MDR and IVDR. Turkish Notified Bodies have to meet the same requirements as European NBs and can act in the same way. A device duly certified by a Turkish NB can therefore circulate freely in Europe.

Similar benefits apply when marketing a medical device in Turkey: the certificates of conformity duly issued by European NBs are in fact fully recognized.

Written by: Riccardo Del Signore

Foto di Roberto Gomez da Pixabay