HPRA and Minister for Health welcome new regulations to improve medical device safety

News Category: Regulatory news

Date: 05/05/2017

Dublin: Friday, 5 May 2017: New EU Regulations for medical devices and in vitro diagnostics which will provide enhanced protection for patients and users have been welcomed by the Minister for Health, Simon Harris T.D. and by the Health Products Regulatory Authority (HPRA) today. The new Regulations, which have been in development since 2012, were published this morning in the Official Journal of the European Union and will come into effect at the end of May*. The enhanced legislation will strengthen and improve the regulatory system for medical devices throughout Europe and will help ensure that medical devices are safe and effective.

The new Regulations are intended to enable regulators to keep pace with significant levels of device innovation in the medtech sector while at the same time enhancing patient safety. This will help ensure that new medical device technologies, which provide patients and clinicians with new therapeutic and diagnostic options, are introduced to the market in a safe and timely manner. The current legislation which governs medical devices has been in place in Europe for over 25 years and regulates over half a million different products. It has been evident for some time that the regulatory system required updates and improvements to reflect the experience and knowledge gained during the intervening period and to cater for new and innovative technologies which continue to emerge. Under the new Regulations, a broader range of products, including products with a non-medical purpose such as dermal fillers, will be more tightly regulated resulting in further safety and performance requirements for medical devices. This will deliver greater protection for all those who use and benefit from these products including patients and healthcare professionals.

Speaking today Minister Harris noted the importance of the medtech industry in Ireland, stating that 18 of the top 25 medtech companies now have operations in Ireland, and employ 29,000 people in over 450 companies. “One of the reasons we have a thriving medical technology industry in Ireland is the country’s excellent reputation as a stable and effectively regulated environment”, the Minister said. He added that good regulation ensures a stable platform for medical technologies to be safely innovated and it paves the way for market access to be achieved in a timely manner.

“The new Regulations are crucial pieces of public health legislation designed to ensure that all medical devices and in vitro diagnostic medical devices placed on the European market are safe for patients and health professionals to use,” Minister Harris said.

Chief Executive of the HPRA, Ms Lorraine Nolan said, “These Regulations will have a fundamentally positive influence on the way products will be regulated both in Ireland and across Europe. This will result in greater regulatory oversight at every stage in the life cycle of a medical device which will hugely benefit and protect both patients and the wider healthcare community.

“Over the last five years, the HPRA has contributed significantly to the development of this legislation, working closely with the Department of Health, with the EU institutions, the Member States and other stakeholders. As the legislation comes into effect, the HPRA will continue to collaborate closely with the authorities of other Member States to ensure that it is implemented in a consistent and harmonised manner across Europe.”

The Minister concluded that the HPRA will continue to work to inform industry and other stakeholders about the requirements of the new Regulations over the coming months and years. He stated that Ireland played a prominent role in the negotiations of the new Regulations at EU level and contributed to the balanced outcome. The Minister thanked the HPRA for their work in this area. 

Under the new legislation, the most complex medical devices will be subject to increased levels of assessment before they are allowed on the market, with an additional review by independent European clinicians to be performed for certain high risk devices. Notified Bodies, who are responsible for the certification of devices across Europe, will be subject to increased and better defined requirements, and an increased level of oversight by regulatory authorities before being permitted to approve devices for the European market. Patients and health professionals will have greater access to information about medical devices available in Ireland with a particular focus on safety and performance data. Medical devices will also be subject to enhanced traceability provisions, including a unique device identifier, to assist in the ongoing monitoring of devices and the identification of devices in the event of a product recall.

The Regulations will impact devices in a range of healthcare environments. For example, they include enhanced provisions for medical devices used in home settings or directly by members of the public recognising the proliferation of available technologies in this area. This is to help to ensure that such devices are suitable and safe to use in a home environment. In addition, the new Regulation dealing specifically with in vitro diagnostics is intended to strengthen the safety standards for these devices by significantly increasing levels of regulatory oversight. In vitro diagnostics, which are commonly found in primary and community care settings, are used to perform tests on samples taken from the human body and range from blood and urine tests to sophisticated DNA technology. Finally, significant additional provisions are also included for clinical research involving medical devices to ensure that such trials are scientifically robust and that appropriate protections are in place for patients enrolled in the trials.

For further information on the HPRA’s role in the regulation of medical devices in Ireland, visit http://www.hpra.ie/homepage/medical-devices.

For those with queries on the implementation of the new legislation, email mdr-ivdrqueries@hpra.ie.


The Regulations were published today in the Official Journal of the European Union:

*Both Regulations are subject to transitional periods with full application of the Medical Devices Regulation after three years and full application of the In Vitro Diagnostic Regulation after five years.

See attached further information on the benefits the new regulations for general public.


Weber Shandwick
Siobhan Molloy / Rachel Galligan             (086) 817 5066 / (087) 791 9901            


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