From 26th November 2017, a conformity assessment body can submit an application to the Health Products Regulatory Agency (HPRA), Ireland to be designated under the new regulations as a Notified Body in Ireland. Regulation (EU) 745/2017 on medical devices and regulation (EU) 746/2017 on in-vitro diagnostics (IVDs) are two new EU regulations which came into force back in May 2017.
Devices can continue to be certified and placed on the market according to the current directives until the date of full application of the new regulations; 26th May 2020 for medical devices and 26th May 2022 for IVDs. On a voluntary basis, manufacturers can instead certify their devices to the new regulations ahead of the date of full application.
The introduction of the new regulations has increased the requirements which must be accomplished before being designated as a Notified Body. Annex VII contains the new requirements and they are divided into four categories: organisational and general requirements; quality management requirements; resource requirements and process requirements.
Under the new regulations, the designation process is anticipated to take up to 18 months after which Notified Bodies can begin to certify devices to the new regulations. It is expected that the first medical device regulation (MDR) designated Notified Bodies will be able to begin assessing and certifying devices to the MDR by mid-2019.
Notified Bodies – designation timetable:
- 26th November 2017: 50 estimated applications for MDR and 25 for in-vitro diagnostics regulation (IVDR).
- December 2017 – January 2018: Initial assessment at national level.
- January 2018 onwards: Referrals to EU joint assessment.
- May 2019: Potential first designation proposals to Medical Device Coordination Group (MDCG).
- May 2020: Full application of MDR.
- May 2022: Full application of IVDR.
To read more about the new EU regulations on designation of Notified Bodies in Ireland, please click here.