The essentials of registration under new European Union Medical Device Regulation (EU MDR) are very similar to those under the current Medical Device Directive (MDD). Namely, those placing medical devices on the European market have to register, as do the Authorised Representatives of non-European Manufacturers, and provide the details of the devices they are placing on the European market. In a nutshell, the changes in the new EU MDR primarily involve an extension of the scope of those who have to register, now applicable also to importers of medical devices, and the amount of data to be provided about each device, which has expanded considerably.
The current MDD’s single Article on registration, Article 14, is replaced by several Articles in the EU IVDR. Primarily; the new Article 29 “Registration of devices”, the new Article 30 “Electronic system for registration of economic operators”, and the new Article 31 “Registration of manufacturers, authorised representatives and importers”. In practice, the steps involved in registering are in reverse order to the Articles: Economic operators must first apply (new Article 31) and be issued with a “single registration number” (SRN). They can then register their devices using this new SRN (new Article 29). This new SRN is not only a prerequisite to being able to register devices in the database, it is also prerequisite to being able to submit an application for assessment to a Notified Body.
According to the new Article 31, the economic operators who are required to register according to the new EU IVDR are Manufacturers and their Authorised Representatives, the same as under the current MDD, now joined by Importers of medical devices. Additionally, the new Article 30 allows EU Member States to establish local registration schemes for distributors of medical devices within their national territories. Once more is known about Distributor registration this page will be updated.
The information required to register an Economic operator (new Article 31) is specified in Section 1 of Part A of Annex VI; the type of economic operator, their name and address and details of contact persons. Again, this is really no different to the current IVDD. In contrast, the information required to register a medical device (new Article 29) has changed beyond recognition compared to the current MDD. The new information requirements, which are listed in Part A (2) and Part B of Annex VI, are considerable. More than 30 elements of data will be required in the database for each medical device, including the new UDI-DI (Device Identifier).
Additionally, according to the new Article 30, within two weeks of placing a device on the market, Importers must perform a compliance check on their suppliers. Importers must verify the information in the registration database is correct and inform the Manufacturer or Authorised Representative if any information is incorrect.
Once more is known about the practicalities of registration process and the availability of the registration database, this page will be updated.