Welcoming new red tape

01 September 2017

The Medical Devices Regulation 2017 is a response to the high-profile products litigation of recent years. It should be good news for insurers.

PIP breast implants. Metal-on-metal hips. Pelvic mesh. Implantable defibrillators. Pacemakers. The list goes on.


A number of high-profile cases in recent years have been brought on the basis that manufacturers had produced medical products that failed to meet acceptable levels of safety. It appeared that the current regulatory framework dating from the 1990s had failed. But in many cases, manufacturers found that they produced devices that performed well but the regulations themselves provided only limited protection against speculative claims that their products were defective.


In response to these issues, the European Union has scrapped the 1990s legislative framework and replaced it with a new regime.


On 25 May 2017, the new EU Regulation came into force and will take effect in 2020 after a transitional period. When Brexit occurs we do not expect the Government or Parliament to amend it in any material way. It ushers in change designed to bring the legal framework regulating medical devices into the 21st Century. For insurers worried about the litigation risk associated with medical products, some key points are:

  • Data. Manufacturers will now be required to obtain more data regarding the safe performance of their devices before they are put on the market. Once on the market, manufacturers will have greater obligations to carry out vigilance and track how their products perform. This means that manufacturers will be better equipped to deal with concerns over the safety of their products: either the products will be recalled more quickly than they are now; or manufacturers will be able to refer to more data to demonstrate that their products are safe.
  • Notified bodies.  Notified Bodies are entities with delegated authority from national regulators, tasked with auditing a manufacturer's quality system and technical documentation before a device can be CE marked and distributed. Notified Bodies will now shift from being industry partners and become more like policemen. This means manufacturers' products and processes will be subject to greater scrutiny before they get to the market. For insurers, this will provide greater assurance that products are safe.
  • Knowledge sharing.  Patients implanted with a device will be given an implant card. The European databank on medical devices (Eudamed) is being overhauled by the new regulations to allow wider access. Patients will be able to use their implant card to access information regarding the safety and performance of their implant. For manufacturers and insurers, it is good news that patients will have more information. The 'worried well' will be reassured; for those with genuine cause for concern, better information exchange can be used to resolve litigation at an earlier stage than it is now.
These are just some of the key provisions in a Regulation that will do much to tackle the problems faced by a sector grappling with outdated laws. Look out for more comment from us on the new Regulation as we head towards 2020.

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