News Category: Regulatory news
Medical devices must meet the requirements of EU regulations and bear a CE mark in order to be legally supplied to the market in Ireland. Certain medical devices, such as those implanted in patients, must be assessed by a conformity assessment body in Europe, known as a Notified Body (NB), before they can be legally supplied. The NB assesses if a device meets the EU regulations. If a device conforms, the NB issues a CE certificate to the manufacturer (see list of Notified Bodies) This allows the manufacturer to place the product on the market. Within the European medical devices legislative framework, the HPRA does not approve or certify medical devices for sale in Ireland or any other EU member state.
The HPRA's role is in relation to monitoring the safety of CE marked medical devices is activated once a medical device is placed and becomes available on the Irish market.
The HPRA understands at this point the 'compression springs' referred to in relation to orthopaedic surgery at CHI at Temple Street were not intended to be sold or supplied as medical devices.
The HPRA does have a role in the approval of clinical studies for investigational medical devices. However, this requires an application to be made to the HPRA by the clinician carrying out the study, which is then subject to a full benefit risk evaluation including assessment of the suitability of the medical device for implantation into the body from a technical and clinical perspective. The clinical study would also be subject to ethics approval by the National Research Ethics Committee, which operates outside the HPRA. The HPRA can confirm that no such application was made to it for the use of compression springs at CHI at Temple Street.
As the HPRA does not regulate clinical practice, the use of products not intended to be sold or supplied as medical devices by healthcare providers, as well as other areas of clinical practice, are matters of clinical governance and fall outside of the remit of the HPRA. However, the HPRA will as always work in partnership with others across the healthcare system as necessary to support any relevant review and outcomes.
To Note: As part of its remit, the HPRA supports the health service and clinicians seeking to conduct clinical studies with new or innovative devices through the provision of advice to ensure they meet regulatory requirements for medical devices. This includes direct engagement, dedicated meetings and lectures/education sessions to support innovators and ensure studies conducted in Ireland are done so in a safe manner to protect Irish patients.
At this point, the HPRA is not aware that any manufacturer or distributor has mis-represented products related to this matter as medical devices. If such information comes to light, the HPRA will follow up with the manufacturer or distributor accordingly.
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Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438