Dáil Éireann Debate, Wednesday - 12 December 2018
193. Deputy Thomas P. Broughan asked the Minister for Health if he will order a review of the regulation of the medical devices sector following the recent international investigation by journalists; and if he will make a statement on the matter. [52480/18]
View answerConcerns around the safety and certification of various medical devices have been raised by “The Implant Files”, an article published in the Irish Times on 26 November 2018.
Medical devices in Europe are currently regulated by legislation which is in place since the early 1990s. Under this system of regulation, devices are assessed and certified by a notified body. These notified bodies (in Ireland the National Standards Authority of Ireland, NSAI) are designated and overseen at each national level by the regulatory authority, in Ireland the Health Products Regulatory Authority (HPRA). The HPRA’s primary roles in relation to medical devices are the market surveillance/vigilance of medical devices once they are on the market and the designation and the designation and oversight of the notified body.
Negotiations on new EU-wide regulations of medical devices and in vitro diagnostic medical devices were formally agreed for implementation by the EU Parliament and Council in May 2017. The new regulations will be implemented in 2020 and 2022 respectively.
The new Regulations represent a significant development and enhancement of the existing legislation; they build on existing principles to strengthen the regulatory framework, make it more effective and more harmonised in its implementation. These Regulations ultimately provide a secure, consistent regulatory framework which will enhance public health in Ireland and across the EU as a whole, by ensuring that medical devices available on the market are safe, perform and afford benefits to patients and to healthcare systems.
Furthermore, in 2013 the Commission launched a joint action plan (referred to as the Dalli Action Plan). The Plan contains concerted actions to: improve the functioning of the notified bodies system and their oversight within the EU; enhance market surveillance activities; and to improve coordination, communication and transparency. Since then enhanced oversight of notified bodies has been achieved through joint assessment of these notified bodies by Member States and the Commission. Joint assessments have contributed to an improved and harmonised regulatory oversight of notified bodies across Europe.
While it is acknowledged that there are risks associated with any medical intervention, the potential benefits of medical devices for many patients, often with critical or long-term illness, means they will continue to play a vital and necessary role in the wider health service.
