Europe Medical Device Registration

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Device Classification

Classification of the device is the very first step in determining the regulatory pathway for the given product. There are about 22 implementing rules for medical devices and are classified as –

ClassRisk
Class ILow
Class IIaModerate
Class IIbModerate to High
Class IIIHigh

Similarly, for IVD, about 7 rules are implemented while classifying into the following four categories

ClassRisk
Class ALow
Class BModerate
Class CModerate to High
Class DHigh

Given the specialized instructions in place for different classes, identifying the right class of device is crucial in determining the Regulatory pathway.

European Authorised Representative (EAR)

Any foreign manufacturer intending to launch their devices in the EU region is obligated to appoint a European Authorised Representative (EAR) in accordance with Article 11 of the EU MDR and IVDR.

Medical Device Registration

In order to market the medical devices in the EU geography, obtaining CE marking is mandatory. Manufacturers are required to identify and appoint notified, go under the conformity assessment, and issue CE certification.

Decoding Regulatory information pertaining to device registration or notification via an online registration system can prove challenging without an expert’s assistance.

Process flow

Post-approval Device Lifecycle Management

The European medical devices regulations highlight now on the importance of post-market requirements. The manufacturer is required to be equipped with a surveillance management system. A periodic information is to be provided for the device.

Freyr can support you in building post-market surveillance (PMS) plan, the post-market surveillance report (PMSR), periodic safety update report (PSUR), and post-market clinical follow-up (PMCF)/ post-market performance follow-up (PMPF).

Freyr supports also includes activities such as –

  • Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between Notified body and the manufacturer

Europe Medical Device Registration

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