Each year, Health Products Regulatory Authority (HPRA) publishes the annual report outlining its activities in the area of public and animals’ health. The Irish agency’s new report was published on November 20, 2021, and summarises last year’s programs development to regulate health products and the safety of cosmetics.
Medical Devices
As the national competent authority for medical devices, the HPRA carries out a range of registration, surveillance, monitoring, and compliance activities. (HPRA, 2021)
HPRA’s 2020 activities primarily focused on timely and effective implementation of Medical Device Regulation (2017/745) at the national and EU levels. The agency’s plans and strategy also covered designation and oversight of Notified Bodies in Ireland under MDR and continues support for the EU in this area.
HPRA emphasizes market surveillance, focusing on proactive actions to ensure safety and quality on the market. In 2020 there were recorded 1.120 market surveillance cases undertaken regarding medical devices and the receipt and assessment of 1,668 medical device vigilance reports.
As a consequence of Brexit, the number of registered economic actors and devices significantly increased. Manufacturers of specific medical devices and in-vitro diagnostics (IVDs) registered in Ireland or local Authorized representatives must register with the HPRA. In 2020, the HPRA registered 183 new medical device economic operators and a total of 20,757 medical devices.
Cosmetics
HPRA regulates the manufacture, sale, and supply of cosmetic products in Ireland. As in the case of medical devices, the agency largely engages in proactive and reactive market surveillance. In 2020 HPRA noted 300 reactive surveillance cases initiated for cosmetic products. The agency identified non-compliance for three distributors and requested to implement corrective actions as part of proactive surveillance. Its actions involved initiating a review of the Product Information File (PIF) to ensure compliance with the Cosmetics Regulation.
The reactive market surveillance activities include investigating quality-related complaints, reports of adverse events relating to the use of cosmetics, and serious risk alerts received from other countries.
The HPRA’s actions are not limited to medical devices and cosmetics. The agency constantly engages on the EU level to ensure market compliance in different regulatory programs.
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Kamila Swiatek
Regulatory Affairs Department
21.01.2022
References:
HPRA (2021). HPRA publishes 2020 Annual Report. Retrieved on 21.01.2022 from http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/hpra-publishes-2020-annual-report&id=6e941026-9782-6eee-9b55-ff00008c97d0