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April 19, 2020
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Healthy & Safety: Medical Devices Regulation

Particularly during these challenging times, medical devices will continue to make an essential contribution to healthcare worldwide. From plasters to scanners, dentures and diagnostic devices, medical devices are crucial in diagnosing, preventing, monitoring and treating illness and disabilities. With public health and safety at risk from the coronavirus outbreak, the industry remains more important than ever.

On 3 April 2020 the European Commission adopted a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. The ultimate goal is for the European Parliament and Council to adopt the proposoal by the end of May 2020 to take the pressure off national authorities, notified bodies, importers, distributors, manufacturers and other stakeholders in order to allow time to focus on the urgent priorities emerging from othe coronavirus disease.

EU law ensures the safety, sufficiency and effectiveness of medical devices, therefore in order to keep updated with scientific and technological advances, 2 new EU regulations are replacing 3 existing directives in the next few years. This is expected to enhance the quality of medical devices on the EU market in the interest of everyone, through the establishment of a modern, robust legislative framework to ensure better protection of public health and security, which will boost confidence in our medical devices industry.

Currently there are three directives on medical devices, namely, Directive on Active Implantable Medical Devices (AIMDD) (1990), Directive on Medical Devices (MDD) (1993), and Directive on in vitro Diagnostic Medical Devices (IVDMD) (1998).

On 5 April 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives.

Medical devices are expected to be safe and have the latest progress in scientific and technological advances. Given that the EU’s latest rules were established in the 1990s, certain discrepancies have existed in their interpretation. Hence, To reflect progress over the last 20 years, the EU has revised the legal framework, with 2 new regulations – one on medical devices and the other on in vitro diagnostic medical devices, which were adopted by the Council and the Parliament, and entered into force in May 2017, as aforesaid.

You can read the full press release from the EU Commission here.

Some of the important improvements of the new rules include stricter ex-ante control for high-risk devices, reinforcement of the criteria for designation and processes for oversight of notified bodies, inclusion of certain aesthetic devices, a new risk classification system for in vitro diagnostic medical devices, improved transparency, introduction of an ‘implant card’, reinforcement of the rules on clinical evidence, strengthening of post-market surveillance and improved coordination mechanisms.

The new regulations will ensure, amongst other things, a consistently high level of health and safety protection for EU citizens using these products, the free and fair trade of the products throughout the EU, and that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years. It remains to be seen however how national authorities will cooperate and implement them as appropriate.

As a result, all relevant stakeholders ranging from manufacturer to user, will have to comply with the new regulations. Therefore, it is important to increase awareness of the changes and start preparing for the implementation of the new regulations as soon as possible.

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