Within the European Union, medical technologies are regulated by laws that are made to ensure the safety and performance of devices throughout their lifetime.
Over the next few years, the European medical technology sector will be transitioning from being regulated under the current medical device directives to two new regulations.
Within this article, we will be exploring these new regulations fully and what changes they will inflict.
What are EU 2017/745 and 2017/746 regulations?
The EU rules on the safety and performance of medical devices were originally created in the 1990s. However, in April 2017, the European Parliament and Council embraced regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory framework for pharmaceutical devices and in vitro diagnostic medical devices.
The new regulations aim to improve on the quality, safety, and performance of pharmaceutical devices placed on the EU market, with a more robust system of conformity assessment. The regulations have been implemented to achieve a higher level of protection when it comes to health of patients, as well as ensuring smoother functioning of the internal market for medical device products. While the Medical Devices Regulation came into force in May 2017, it only became applicable in 26th May 2021. The transition period provided for the regulation was originally intended to end on 26th May 2024, however this has now been extended.
Why have the deadlines of the new medical device regulations been extended?
The medical device regulations EU 2017/745 and 2017/746 were recently extended as many of those affected were struggling to reach the deadlines, which posed a risk of shortages if uncertified devices were to be removed from the market. It was also true that the overall capacity of conformity assessment bodies was considered to be insufficient to carry out necessary tasks. This meant that many manufacturers reported a lack of preparation to meet the requirements of the MDR by the end of the transition period.
As this could potentially be a threat to the availability of medical devices on the market in the EU and negatively impact innovation and business activity in the medical technology sector, the Commission has proposed a much longer transition period to adapt to the new rules. This will include revised deadlines based on the medical devices risk class.
In January 2022, the European Parliament and Council approved a staggered extension of its transition period. This extension was from 26th May 2025, for high-risk in vitro diagnostics, to 26th May 2027, for lower risk in vitro diagnostics. On top of this, there is a further extension to as far as 26th May 2028 for provisions involving pharmaceutical devices manufactured and used in health institutions.
The commission has also proposed to remove the ‘sell-off’ date currently established in the MDR, to ensure that medical devices that are deemed to be safe remain available to healthcare systems and patients in need.
Please note, that the proposal will not change any of the current safety and performance requirements for the Medical Devices Regulation. Instead, it will only amend transitional provisions to allow more time for manufacturers to adapt.
See the image below for an example of the new timeline.
Which products benefit from the extension?
For further clarification, the extension applies to a range of medical devices such as pacemakers and syringes that are currently already covered by the transition period. This means that the extension only applies to the ‘legacy devices’ like those that are covered by a certificate or declaration of conformity issues under Council Directives 90/385/EEC or 93/42/EEC before 26th May 2021.
In addition to this, the Commission have also introduced an introduction to the transition period until 26th May 2026 specifically for Class III custom-made implantable devices such as patient specific implants for bone reconstruction. It is expected that manufacturers of Class III custom-made implantable devices comply with all applicable regulation requirements since May 2021, but will now be given more time to acquire clarification of their quality management system.
What are the main benefits of EU 2017/745 and 2017/746 for patients?
Here are some additional benefits of the new regulations for patients:
- Better post-market surveillance: The new regulations require manufacturers to implement an extensive post-market surveillance system, which allows for the continuous monitoring of the safety and performance of medical devices once they are on the market. This will help to identify any issues or risks that may occur and allow for actions to be taken to ensure patient safety.
- Improved transparency for patients: The new regulations require manufacturers to provide more information to patients about the medical devices they are using, including information about the device's intended purpose, risks, and benefits. Patients will also have access to a public database that contains information about all medical devices on the market in the EU. This will help to empower patients to make more informed decisions when it comes to their healthcare.
- Stronger clinical evidence requirements: The new regulations call for manufacturers to provide stronger clinical evidence to support the safety and performance of their medical devices. This will help to ensure that only safe and effective devices are placed on the market, and that patients can maintain confidence in the devices they are using.
Overall, the new EU regulations for medical devices aim to ensure a high level of protection for patients while also promoting innovation and competitiveness for medical technology. By improving the safety and performance of medical devices, these regulations will help to improve patient lives and contribute to the sustainability of healthcare systems across the EU.
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