Medical Devices Regulation on the horizon
The EU Regulation on Medical Devices 2017/745 (the MDR) had been due to become fully applicable on 26 May 2020.
However, its implementation has been delayed by the EU until 26 May 2021. The MDR replaces Medical Device Directive 93/42/EEC. To cater for Brexit, the UK is expected to transpose the key elements of the MDR into UK legislation. Medical device manufacturers will need to prepare to comply with a greater regulatory burden designed to improve product safety.
Why does it matter?
The MDR was drafted in the aftermath of high-profile litigation concerning medical devices, such as the PIP breast implant litigation and metal-on-metal hips litigation. The new law recognises that the previous regulatory regime had struggled to keep up with technological developments over the past 25 years. The MDR is intended to improve the traceability features and safety management of medical devices for sale in the EU.
It is hoped that in return for incurring the expense of compliance with the MDR, manufacturers will be able to take advantage of a reduced risk of litigation from patients or consumers. Manufacturers should reap the benefit of a new regulatory regime that intended to make medical devices safer.
New rules under the MDR include:
- An expanded definition of medical devices, to include aesthetic products.
- A restriction on manufacturers’ ability to “self-certify” that their products comply with regulatory standards.
- New rules for determining risk classification.
- Requirements for manufacturers to have in place sufficient financial cover for potential liability.
- Obligations on manufacturers of apps, including requirements in respect of security measures.
- Greater oversight of Notified Bodies (the organisations designated by EU regulators to assess conformity of products before they are placed on the market).
- A requirement for manufacturers to use unique identification codes to improve the identification and traceability of devices once they are in the market.
- Obligations on other entities in the supply chain, including importers and distributors, to cooperate with manufacturers over tracing of devices.
What actions should you take?
- Assess whether your products are covered by the expanded definition of a medical device.
- Be prepared to gather information from postmarket experience with your devices, to update technical documentation and cooperate with regulators charged with overseeing market vigilance activity.
- Consider investing in technology to enable the tracing of products and packaging once they are in the market place.
- Consider whether apps relating to fitness and health issues fall within the scope of the MDR.
- Review your financial provisions to ensure you have cover for potential liability for defective products, which may be in the form of insurance.
- Engage with your distribution chains to ensure other parties comply with their obligations to track and recall products.
This summary forms part of our annual Regulatory Radar – an overview of the key regulatory changes you need to have on your radar, from Medical Devices Regulation to post-Brexit data transfers.
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