Dive Brief:

• The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages.
• EU Health Commissioner Stella Kyriakides seeks to pair the delay with “additional measures to address the structural problems” of MDR, including the need for targeted solutions to the problems facing rare disease devices.
• One critic of the Commission’s proposal said a key component of the proposal, a plan for extending the validity of existing devices, is a “sticking plaster solution,” using the British term for a Band-Aid.

Dive Insight:

A steady stream of warnings about the impact of MDR on medical device supply again has driven the EU to act. Officials changed the original timeline in response to the COVID-19 pandemic and allowed devices with valid certificates under the old directives to stay on the market until 2024. However, as the deadline has approached, worries that the EU lacks the capacity to process the backlog have intensified. 

Six new notified bodies have received MDR designation since June, creating a pool of 36 organizations that need to process around 23,000 certificates by May 2024 if all current devices are to stay on the market. The equation has led Kyriakides to accept that a delay is necessary.

“The transition to the new rules has been slower than we anticipated. The pandemic, shortages of raw materials caused by Russian war against Ukraine and low notified body capacity has put a strain on market readiness,” Kyriakides said. “We are facing a risk of shortages of life-saving medical devices for patients. This is a risk we cannot take.”

Noting factors that have “put a strain on market readiness,” Kyriakides outlined plans to delay the deadline for MDR certification to 2027 for high-risk devices and 2028 for medium and low-risk devices. EU authorities have yet to confirm whether the transitional period will be combined with an extension of the validity of certificates for existing devices issued after MDR adoption. 

"Delaying the Medical Devices Regulation without extending the validity of certificates under the directives is a sticking-plaster solution,” said Alison Dennis, a London-based international co-head of life sciences and healthcare at law firm Taylor Wessing. 

“Under current plans, outlined by the publication of MDCG 2022-18, medical devices with certificates that expire before they receive MDR approval have to go through a new derogation process. It is an administrative burden for both companies and competent authorities to have to make these applications," said Dennis. “Their time would be better spent on getting medical devices certified under the [existing] regulations.”

Dennis said it would be preferable for the new rules to provide for an automatic extension of existing certification. "Manufacturers are likely to have to ask and potentially ask repeatedly for extensions," she said.

Kyriakides is also proposing to remove the “sell-off” date that would have required some marketed medical devices to be discarded in May 2025. The plan is to have the amendment ready for review by EU politicians at the start of next year.

If passed into law early in 2023, the amendment will give the EU, manufacturers and notified bodies four to five years, depending on the risk classification of a device, to fix the problems that have forced officials to twice delay MDR. 

Kyriakides, the EU commissioner, also spoke about the Commission’s efforts to support solutions for rare diseases. 

“We should develop together solutions on orphan devices, to ensure patients with rare diseases continue to have access to those devices,” Kyriakides said. “We must also shape a regulatory environment that fosters innovation and ensures that notified bodies are enabled to focus on the key task at hand, patient safety and less bureaucracy.” 

Kyriakides’ focus on orphan devices is in line with the concerns raised by the Biomedical Alliance in Europe, which recently called for a special framework for orphan medical devices. The EU Health Commissioner also outlined plans for a pilot project that will “offer scientific advice from the expert panels on medical devices” to manufacturers of orphan and breakthrough devices and for more support for small and medium-size enterprises.

Update: Expands and clarifies comments by Alison Dennis.