On 5 April 2017, the European Parliament and the European Council adopted the new EU Medical Devices Regulation EU 2017/745. The directive, which is also known as the “Medical Device Regulation” (MDR), was published in the EU Official Gazette on 5th of May 2017 and entered force 20 days later – on 26/05/2017. Since it is a regulation, it is not necessary for individual Member States to adopt appropriate national laws. It has immediate legal force and will become binding for the whole EU.
This includes a transitional period of 3 years. As of 26 May 2020, the provisions contained in the Regulation will therefore have to be implemented in a binding manner.
The 175-page set of rules is available for download on the EU website .
Regulation EU 2017/745
We have reported in our blog about the upcoming new regulation 5 years ago . In a similar form, it has been binding for the USA for some time. All manufacturers of medical devices exporting to the USA are therefore already familiar with the topic.
UDI: Clear identification
Part of the new MDRs are also new requirements regarding the unambiguous identification of medical devices – the “Unique Device Identification” (UDI). It is regulated by Article 27 (“System of Unique Product Identification”) and Annex VI to the Regulation. Labelling must be on product and packaging and should enable the clear identification and traceability of products. Security-relevant measures are to be facilitated and counterfeiting is to be countered.
Article 27.4 provides: (4) The UDI bearers shall be marked on the label of the product and on all higher packaging levels. ”
The date for this new marking under Article 27.4 results from the classification of the product and is described in Article 123 (“Entry into force and date of application”). Class II implantable products and products are subject to 26 May 2021, Class IIa and Class IIb products are May 26, 2023, Class I products are May 26, 2025.
Incidentally, the MDR also contains new rules for the classification of products (Annex VIII).
Also for reusable products a permanent, clear UDI-marking on the product is prescribed, so that cleaning, disinfection, sterilization or preparation can be tracked.
For those reusable products in which the UDI carrier is to be placed on the product itself,
Article 27.4 shall be applied two years after the above date for the respective product class.
The UDI consists of two components:
The UDI product identifier “UDI Device Identifier” (UDI-DI) uniquely identifies the manufacturer and product. The UDI production identifier “UDI-Production Identifier” (UDI-PI) shows the production unit of the product – ie depending on the product lot identification, serial number, minimum durability date, date of manufacture.
Database EUDAMED
At the same time, the regulation stipulates that the UDI-DI must be placed by the manufacturers in an EU-uniform database called EUDAMED. This database then contains all relevant general and specific information on the manufacturer and product.
The setting in the database becomes therefore earlier binding than the application of the clear marking on product and packaging. Per experience, manufacturers will, in their own interest, begin with the application before the obligation occurs, to allow a clear assignment. In our estimation, one or other manufacturer will then also use the extended possibilities of modern marking systems that are necessary anyway. For the purpose of quality assurance, traceability and anti-counterfeiting protection, many will probably envisage a serialization of their own products, which will become binding in the pharmaceutical industry from 2019 onwards .
The Federal Ministry of Health has recognized the extraordinary challenges that will arise in the implementation of the directive throughout the industry. It has therefore initiated a “National Working Group on the Implementation” of the MDR – abbreviated as NAKI.
It is to be expected that this work group will soon be able to help with the implementation of the Council.
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