The European Medical Device Regulation (MDR) has brought significant changes to the medical device industry, and it's important for medical device companies to stay informed and compliant. In this article, we'll answer some common questions about the MDR to help you better understand the regulation and its impact.

What are the benefits for patients?

The medical device market has over 500,000 types of devices, ranging from simple contact lenses to complex implants. Most people will need to use a medical device at some point in their lives.

The new Regulation focuses on patient-centered healthcare, prioritizing transparency, patient information, and choice. Patients can benefit from innovative, high-performing devices and new therapies. The improvements include:

• Stricter ex-ante control for high-risk devices through a new pre-market scrutiny mechanism with a pool of experts at EU level.
• Reinforcement of criteria for the designation and oversight of Notified Bodies (independent third-party conformity assessment bodies).
• Inclusion of certain aesthetic devices with similar characteristics and risk profiles as medical devices under the regulation's scope.
• Improved transparency through the EU database on medical devices (EUDAMED).
• A traceability system based on a unique device identifier (UDI).
• Introduction of an "implant card" containing information for patients with implanted medical devices.
• Reinforcement of rules on clinical evidence, including a coordinated EU-wide procedure for authorizing multi-center clinical investigations.
• Strengthening of post-market surveillance requirements for manufacturers.
• Improved coordination mechanisms between EU countries on vigilance and market surveillance.
• A robust financial compensation mechanism to ensure patients are compensated for damage caused by defective devices.

Why extend the transition period for the Medical Devices Regulation?

The European Commission is proposing an extension of the transition period for the Medical Devices Regulation due to limited capacity of notified bodies and insufficient preparation by manufacturers to meet the robust requirements of the new regulatory framework. This poses a risk of significant disruption in the supply of medical devices on the EU market, potentially affecting healthcare systems and their ability to provide care to patients.

Which transition periods will apply?

The proposed extension of transition periods will vary depending on the risk level of the medical device. Higher risk devices such as implants will have a shorter transition period until December 2027, while medium and lower risk devices like syringes or reusable surgical instruments will have longer periods until December 2028.

Is the entire Medical Devices Regulation postponed?

No, the Regulation has been in effect since May 2021 and remains applicable. However, the proposed amendment only affects the transitional provisions, allowing manufacturers and notified bodies more time to transition to the new regulatory framework, subject to specific conditions. No changes are made to the requirements of the Regulation itself.

What products will benefit from the extension and what are the conditions?

The conditional extension applies to legacy devices covered by certificates or declarations of conformity issued before May 26, 2021, subject to several conditions to ensure device safety. The extension also applies to class III custom-made implantable devices, which were not previously covered, with a transition period until May 26, 2026, if the manufacturer has submitted an application before May 26, 2024, resulting in a contract with a notified body before September 26, 2024.

Will the extended transition periods compromise patient safety?

No, the extended transition periods will only apply to devices that are safe and for which manufacturers have already taken steps to transition to the Medical Devices Regulation. The goal of the proposed amendment is to ensure patients' access to medical devices while transitioning to the new framework. The slower transition has been caused by the COVID-19 pandemic, global supply chain disruptions, and limited capacities of conformity assessment bodies.

The Commission proposes to delete the 'sell-off' date - doesn't this allow low quality devices to remain on the market for a very long time?

The 'sell-off' date is the final date by which devices that are already on the market but not yet with the end user must be withdrawn. Removing this date will decrease the risk of shortages and prevent safe medical devices from being needlessly discarded, which will have a positive effect on both patient safety and the environment.

Only devices that complied with the previous legislative requirements, i.e., the EU medical devices directives, will benefit from this provision, as their safety was evaluated when they were initially placed on the market. This provision, along with the cumulative conditions for the extension of the transition period, will ensure that after May 26, 2024, only medical devices for which the manufacturer has submitted an application for conformity assessment to meet the requirements of the new system may be placed on the market. Once the conformity assessment is completed, the manufacturer will be interested in selling their newly approved devices.

Furthermore, devices with a limited shelf-life cannot be sold after their shelf-life has expired. The current Regulations' safeguards, such as market surveillance activities and the reporting and analysis of serious incidents (vigilance), will also apply to those devices to protect patients and users.

Secure Your MDR Certification with Medasia's Future-Proof Products

The European Medical Device Regulation (MDR) is constantly evolving, with new guidelines emphasizing greater standardization, stricter post-market surveillance requirements, process-oriented risk management, and a lifecycle approach to device management. To ensure compliance throughout the entire product lifecycle, you need a future-proof solution.

With Medasia, you can confidently bring safe and effective medical devices to market while staying up to date with the latest MDR guidelines. Don't risk non-compliance – secure your MDR certification today with Medasia's future-proof homecare products.

PS: If you want my team to OEM your own MDR products, please contact insights@medasiagroup.com

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