Click now to listen to RCA’s Director of Regulatory Affairs, Jordan Elder, in this RCA Radio audio update about Medical Device Regulation, or MDR:
The European Parliament voted for a timeline extension in 2023 to MDR regulation, including an extended timeline for medical device regulatory submission. The 537-3 vote by members of the official body provides a final approval to extend MDR deadlines for compliance. Included in the legislation is revisions to regulatory submission rules for certifying medical devices. Additionally, the timeline includes new dates for both Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
European officials extended the MDR regulation to include legacy devices with existing certificates under the MDD to stay on the market until 2024. Industry executives have suspected for some time that the EU MDR backlog of submissions would lead to a slower process of legal regulation. Equally important, many EU health ministers voiced their opinion during a December 2022 session medical device shortages would occur without a MDR timeline extension.
Manufacturers now have until 2027 or 2028 to have medical devices certified and approved under MDR guidelines & regulation law. The timeline includes new dates for both high-risk medical device products and low risk medical devices. 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 Class III and IIb;
- 31 December 2028 for Class IIa and I.
- 26 May 2026 for Class III implantable custom-made devices
The original “sell-off’ date requirement that was required under the MDR has been removed
Need help with your MDR or IVDR transition? Talk to our Experts →
Meanwhile, the EU Commission has previously recommended the IVDR application date be extended due to the EU notified body bottleneck.
- General EU MDR Class 1 Low-risk devices that are non-measuring, non-sterile, non-reusable, non-surgical, and that do not require review from a notified body will still go into effect in 2022.
- Non-sterile Class A and B Devices (low risk) – May 26, 2022
- Class D (Highest Risk) – May 26, 2025
- Class C (Medium Risk) – May 26, 2026
- Sterile Class A and B Devices (low risk) – May 26, 2027
Life science media outlets have reported extensively on the change since it was proposed at the meeting.
Stella Kyriakides, the European health commissioner, first proposed postponing the current MDR deadline dates during the EPSCO council meeting in Brussels. The health commissioner projected around 23,000 devices and 1,500 IVDs are currently approved and certified under MDD, but have not yet transitioned to the new MDR regulation. These medical devices are likely to expire in 2024 and 2025,
“The transition to the new rules has been slower than we anticipated,” said Kyriakides. “The pandemic, shortages of raw materials caused by the Russian invasion against Ukraine and low notified body capacity has put a strain on market readiness.”
Medical Device Manufacturers
Additionally, many unique viewpoints have emerged about the current landscape and the impact of recertification.
“If the three-year deadline is truly unattainable, these extensions could prevent devices that are perfectly safe for use from being taken off the market because they were unable to get recertified in time,” said Alexandra Murdoch, a medical analyst at GlobalData.
Murdoch added both medical device manufacturers and suppliers must now deliver MDR regulatory documentation for market approval, including data about materials used in medical device manufacturing.
Medical Device Safety
Both Pinto & Rocha have documented the MDR proposal concerns that “only medical devices considered safe will benefit from the extension”. This includes medical device manufacturers that have begun the process of submission and certification under the MDR.
Further, the Commission has recognized the ongoing need for patient safety and proposed a 2023 pilot project for medical device manufacturers. For example, expert panels to advise manufacturers with qualified scientific advice about devices that help treat rare diseases.
Medical Device Shortage
Ireland’s minister of health, Stephen Donnelly, supported the change based on COVID-19 procurement and preventing future medical device shortage scenarios.
“Participation in the EU COVID-19 vaccine strategy has allowed us to conduct the largest immunization program in our country’s history, saving countless lives and enabling the resumption of normal social and economic life.” said Donnelly.
“This measure needs to be adopted and take effect without delay to ensure that the devices our citizens and health systems rely on remain available.”
By contrast, it is still unknown how different types of EU legislation will regulate connected medical devices. There is concern across the industry about which legislation may take precedence and the level of postmarket surveillance data needed.
The European Commission (EC) published a proposal for a Cyber Resilience Act (“CRA”) to strengthen cybersecurity across medical device interoperability. Both Wright & Wenzel have documented this legislation does not consider MDR to impose as many obligations on medical device manufacturers. Further, the commentary suggests the EC may not require as much documentation about unknown vulnerabilities are not present for medical devices.
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- 21 CFR 210
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About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
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About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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