The EU Health Commissioner has proposed delaying the MDR to prevent shortages of medical equipment.

Dive Brief:

• They have a European Union health commissioner. proposed that Delaying the implementation of the Medical Device Regulation (MDR) by three to four years to prevent product shortages.
• European Union Health Commissioner Stella Kyriakides He wants to combine the delay with “additional measures to address the structural problems” of the MDR, including the need for solutions that target the problems faced by rare disease devices.
• Regarding the extension, one critic called it a “sticky plaster solution”. Using the British word for band-aid.

Dive Insight:

Continued warnings about the impact of MDR on the supply of medical equipment have prompted the EU to take action. Officials have changed the original timeline in response to the Covid-19 pandemic, allowing devices with valid certification to remain on the market until 2024 under the old guidelines. However, he is concerned that the EU will not be able to carry out this process as the deadline approaches. Back story They got worse.

Since June, six new recognized bodies have received the MDR designation, creating a group of 36 organizations that will need to carry out 23,000 certifications by May 2024 if all devices are to remain on the market. The equation led Kyriakides to admit that delay was necessary.

“The transition to the new regulations is slower than we expected. The epidemic, the shortage of raw materials caused by the war in Ukraine in Russia and the low capacity of the notified body have put pressure on market readiness,” Kyriakides said. This is a risk we cannot take.

Citing factors that “put pressure on market readiness.” Kyriakides He outlined plans to delay the deadline. MDR Certification until 2027 for high risk equipment and 2028 for medium and low risk equipment.

As well as extending the validity of regulatory certificates, Kyriakides proposed removing the May 2025 “sell by” date that would have forced certain marketed medical devices to be withdrawn. The plan is for the reform to be ready for review by EU politicians. Early next year.

In the year If passed into law in early 2023, the amendment will give the EU, manufacturers and notified bodies four to five years, depending on the device’s risk classification, to correct the problems that forced authorities to delay the MDR twice.

The decision was made by London-based co-head of global life sciences and healthcare at Taylor Wessing, lawyer Alison Dennis said: “A. Adhesive-plaster solution. “It creates an administrative burden for both companies and competent authorities to make these applications,” she said in an emailed comment, adding that “their time would be better spent obtaining medical device certification.” [existing] Regulation.”

It is recommended that Dennis provide an automatic extension of the current certificate to the new regulations. “MProducers can ask for extensions and ask again and again,” she said.

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

“To ensure that patients with rare diseases continue to have access to these devices, we must jointly develop solutions to orphan devices.” Kyriakides he said. “We need to create a regulatory environment that encourages more innovation and allows recognized entities to focus on the key task at hand, patient safety, and less bureaucracy.”

Kyriakides’ focus on orphan devices echoes concerns raised by the European Biomedical Alliance. It is called Special framework for orphan medical devices. The EU Health Commissioner has also planned a pilot project that will provide additional support to manufacturers of orphan and hatchery equipment and small and medium-sized enterprises.