Long awaited strengthening of Medical Device Regulations will hopefully protect patients
Posted in [Blog] on Wednesday, March 10th, 2021
Adequate regulation and legislative safeguards for medical devices has been lacking in Ireland for a number of years. Compared with medicines, investigations revealed that medical devices, were often inadequately tested, which resulted in unsafe products which were then inserted in a patient’s body.
In Cantillons, we continue to act on behalf of people injured by recalled medical devices including DePuy ASR hip devices, spinal rods, Oculentis intraocular lenses, vaginal mesh products, breast implants and others. A number of these cases have already been successfully resolved achieving compensation for the injured victims.
Thankfully, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were launched in 2017. The Regulations will finally take full effect from 26 May 2021 and 26 May 2022, respectively. They represented a long-awaited strengthening of the European regulatory system for the medical device industry. The multi-million Euro business of Medical devices include products such as contact lenses, plasters, pacemakers, PPE equipment, x-ray scanners and prosthetic limbs etc. In vitro diagnostic medical devices include reagents for laboratory tests and diabetic test strips etc.
These Regulations apply directly across the EU and do not require additional specific National legislation. They represent significant reform and a long overdue overhaul of the outdated existing regulations. Due to the extensive changes, obligations and far-reaching effects, a transition period providing for staged introduction of the Regulations was allowed in order to enable manufacturers, Notified Bodies and authorities to comply.
In short, the European Commission believe that the Regulations will modernise and improve the current system of medical device production, certification and trade. The aim and hope is that they will standardise regulation across the EU, tighten safety and thereby avoid any further medical device controversies which have caused such lasting damage to victims to date.
The main aims include:
- Strengthening the regulatory system
- Accounting for technological and scientific progress
- Improving transparency and traceability regulatory system
- Improving performance of Notified Bodies for medical devices
- Mandate clearer requirements for clinical data on medical devices and its assessment
- Mandate more specific product requirements
- Improving pre-market assessment of high-risk devices
- Providing enhanced provisions for market surveillance
- Improving governance, coordination and cooperation
The interplay between these Regulations and existing Defective Product legislation is that the Regulations set the more stringent standard by which a medical or in vitro device will be found to be defective. How it plays out in practice remains to be seen.
Specifically, the new rules will:
- Impose tighter controls on high-risk devices including for example requiring a pool of experts at EU level to be consulted before a device can be placed on the market.
- Require a mandatory unique device identifier for every product so that it can be found in the new European database of medical devices, allowing for more efficient recalls where required.
- Require re-certification of existing products and compliance with the General Safety and Performance Requirements.
- Require updates to technological documentation, clinical data and labelling.
- Have a Notified Body for each relevant device.
Manufacturers will be required to have measures in place to provide sufficient financial coverage in respect of potential liability, with the goal of protecting patients in the event of manufacturer bankruptcy. This is thought to be in response to the PIP breast implant saga where many injured Plaintiffs were unable to recover damages, as the manufacturers had insufficient liability cover.
In addition to a manufacturer/supplier, the Notified Body can now be held liable, providing Plaintiffs with a further avenue of redress.
Time will tell if these Regulations are enough to guarantee patient protection.
Conntact us at Cantillons Solicitors at +353 (0)21 -4275673 or firstname.lastname@example.org if you would like more information.
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