EU Medical Device Regulation

//EU Medical Device Regulation

May 2017: Publication of Regulations in Official Journal of European Union and entry into force

May 2020: Full application of MDR at 3 years (after entry into force)

May 2022: Full application of IVDR at 5 years (after entry into force)

Scope:

Apply to all medical devices placed on the market except custom-made devices

Approach:

Substantially based on internationally recognised principles and guidance but there are some specific EU aspects, namely:

  • The UDI database is part of a more comprehensive medical device database (EUDAMED). UDI is the access key to device-related information in EUDAMED.
  • Introduction of an additional unique identifier having an administrative purpose – the Basic UDIDI (it does not appear on any trade item).
  • EU specific UDI data elements, such as the Single Registration Number identifying the manufacturers/AR (generated by EUDAMED), the future EU medical device nomenclature.

Main UDI-related obligations introduced:

For manufacturers:

  • To assign a UDI to the device and – if applicable – to all higher levels of packaging a UDI before the device is placed on the market.
  • To place a UDI carrier on the label of the device and on all higher levels of packaging.
  • To ensure that certain defined information is correctly submitted and transferred to the UDI database.

For all economic operators:

  • To store the UDI (preferably by electronic means) of all Class III implantable devices – secondary legislation might expand the scope of this provision.

Main deadlines :

Submission of UDI core data elements to the database:

  • By 25 November 2021 for MD and 25 November 2021 for IVDs (unless EUDAMED is not functional by that date)
  • As from 26 May 2020, the full registration of devices remains a pre-condition for the possible registration of their relevant serious incident in EUDAMED-
  • “Legacy devices” placed on the market after the general dates of application of MDR to be registered in Eudamed without a (Basic) UDI-DI.

Placement of the UDI carrier:

– Implantable devices and Class III devices (and Class D IVDs): 1 year after the date of application.

– Class IIa and Class IIb devices (Class C and B IVDs): 3 years after the date of application;

– Class I devices (Class A IVDs): 5 years after the date of application;

– Reusable devices that shall bear the UDI Carrier on the device itself: 2 years after the date applicable for its respective class of devices.

Contact us to know how Verifarma can help you to comply with MDR and UDI compliance: info@verifarma.com

2019-05-20T10:33:59+00:00 May 20th, 2019|Categories: Uncategorized|