Medical devices and in-vitro
diagnostic medical devices that are in compliance with the requirements set out in the legislation are CE marked before being placed on the market. For Class I medical devices and general category IVDs, the manufacturer declares conformity with the legislation and CE marks the device / IVD (self-declaration of compliance).
For AIMD, class IIa, IIb and III devices, sterile devices, devices with a measuring function, self-test IVDs and for IVDs listed in Annex II of Directive 98/79/EC, in order to be CE marked, a manufacturer must submit an application to a designated notified body who then assesses the conformity of the device and issues the manufacturer with a CE certificate if the device meets all of the necessary requirements of the relevant legislation.
Notified bodies assess:
- All medium and high risks devices (class IIa, IIb and III) for conformity;
- Class I devices with a measuring or sterile function;
- All active implantable medical devices;
- In-vitro diagnostic medical devices according to the relevant legislation.
Notified bodies are designated by their national Designating Authority (in Ireland the HPRA) as competent to assess the conformity of particular device types which are identified by ‘scope codes’ such as MD 0204 - Non-active soft tissue implants, MD 0300 - Devices for wound care, MDS 7001 - Medical devices incorporating medicinal substances or MDS 7002 - Medical devices utilising tissues of animal origin. The scope codes for the existing Directives are set out on the European Commission’s NANDO website.
All notified bodies which are designated to assess medical devices are listed on the EU Commission’s NANDO website which can be referred to for an up-to-date listing. As part of the designation process, notified bodies listed on this website undergo a national designation assessment and an independent assessment by experts from EU authorities and the EU Commission.
A manufacturer may choose any notified body throughout Europe to assess their medical device provided that notified body has been designated to assess devices of that type as indicated by the scope code. Therefore a notified body CE certification allows for pan-European access of the certified medical device without a specific national authorisation by an authority like the HPRA. The notified body does not need to be based in the same European country as the manufacturer.
Applications for Designation
For applications for designation or applications for extension to the scope of designation for notified bodies under the existing Directives please contact HPRA at email@example.com
From 26 November 2017, existing notified bodies or other suitable organisations may submit applications to become designated under the new EU legislation on medical devices. Application for designation under MDR/IVDR New EU Regulations: Further Details on Designation of Notified Bodies
Ongoing Oversight of Notified Bodies based in Ireland
The HPRA conducts ongoing oversight of the designated notified bodies based in Ireland to ensure they are performing effectively and are retaining the necessary competence to undertake their designated activities. This oversight primarily consists of an annual plan for surveillance audit of the notified body premises (EU and/or non-EU) and observed audits of a designated notified body’s auditors conducting quality system assessments on site at a clients’ premises. The HPRA also conducts reviews and oversight assessments of notified body related matters by desk review on an ongoing basis. The HPRA will follow up as appropriate on questions received relating to notified bodies based in Ireland. Please send any queries to firstname.lastname@example.org