Test house shortage delays medical device approvals
Medical device makers are not ready for new European regulations and a shortage of test house capacity is forcing a delay in the implementation.
The European Parliament and the Council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 in April 2017 to reinforce the regulatory framework for medical devices and in vitro diagnostic medical devices. This aimed to provide a higher level of protection of health for patients and users and to ensure the smooth functioning of the internal market for medical device products.
The regulations entered into force in May 2017 and became applicable on 26 May 2021 with a transition period that ends on 26 May 2024. An additional ‘sell-off’ provision allows for the further making available until May 2025 of medical devices which are placed on the market before or during the transition period and which are still in the supply chain when the transition period has ended.
There are more than 500,000 types of medical devices on the market, ranging from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements.
The improvements include stricter control for high-risk devices via a new pre-market scrutiny mechanism with a pool of experts at EU level and improved test house and certification capacity.
It also now includes certain aesthetic devices that present the same characteristics and risk profile as analogous medical devices under the scope of the regulation, such as smart watches with health monitoring, a new comprehensive EU database on medical devices (EUDAMED) and a traceability system based on a unique device identifier (UDI).
However this is all being held back by a lack of test house capacity. The Medical Devices Regulation has significantly tightened the requirements to be met by notified bodies. This has also an impact on the length of the designation process.
So far, only 36 notified bodies have been designated under the Medical Devices Regulation. 26 applications for designation as a notified body are pending.
“Despite important progress made in the implementation of the Regulation, the overall capacity of notified bodies remains limited for ensuring a successful transition to the new regulatory framework,” said the European Commission. “In addition, many manufacturers are not sufficiently prepared to meet the robust requirements of the Medical Devices Regulation by the end of the current transition period. This threatens the availability of medical devices on the EU market. Without any legislative action, there is a risk of significant disruption in the supply of various medical devices on the market, affecting healthcare systems and their ability to provide care to European patients.”
For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices.
The proposal also introduces a transition period until 26 May 2026 also for implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body.
The ‘sell off’ date is also being removed, to reduce the risk of shortages and prevent waste.
The EU4Health Programme is also adding targeted action to support the capacity of test houses with a specific focus on SMEs and a survey of key actors operating on the market namely notified bodies and manufacturers, including SMEs.
The Commission is also planning to make use of the Enterprise Europe Network to raise awareness on regulatory requirements and provide targeted support to SMEs active in the medical devices sector.
health.ec.europa.eu/medical-devices-sector/new-regulations_en
