Medical Device Manufacturers, EU MDR compliance

Ensure EU MDR 2017/745 Compliance by September 26, 2024

September 26, 2024, is a critical deadline for life sciences companies selling medical devices in the European Union. By this date, medical device manufacturers must have collaborated with their notified bodies to secure extensions for their medical devices to comply with the EU 2017/745 Medical Device Regulation (MDR).

Overview of EU MDR 2017/745: What You Need to Know

The MDR 2017/745 was initially established to influence quality improvements in medical devices being sold in the EU to update previous regulations, to reflect technological progress since the 1990s, after quality concerns surfaced related to adverse consequences resulting from medical devices, examples being a metal hip replacement prosthesis and a breast implant scandal.

Essentially, the medical device regulation MDR 2017/745 (officially titled “Regulation (EU) 2017/745”) created device classifications whereby the regulatory requirements were increased commensurate with the level of risk the devices posed to patients, and established tighter controls on higher risk devices. Also, among very many other conditions, this MDR also required that the “manufacture and use of the devices occur under appropriate quality management systems.” This regulation meant that medical device manufacturers, with devices already approved for the EU and in the market, or CE-marked products close to market introduction, would need transition time to comply with MDR 2017/745.

Regulation (EU) 2023/607, which became effective on March 20, 2023, provided an extension of the transition periods for medical device manufacturers to meet the MDR 2017/745. It also addressed the potential unintended consequence that may result from manufacturers selling off legal and safe devices in the event the workload on the notified bodies made it difficult to impossible to complete the required conformity assessments for the device companies, by the original deadline dates established.

Regulation (EU) 2023/607 documentation cites, “Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024. It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, in particular when the complexity of those new requirements is taken into account.

Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union. (5) In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and to extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market. The extension should be of sufficient duration to give notified bodies the time needed to carry out the conformity assessments required of them. 

The extension aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.” 

Key Dates for EU MDR 2017/745: Implications for Medical Device Manufacturers

The transition extension deadlines are:

  • May 26, 2026 for Class II implantable custom-made devices
  • December 31, 2027 for Class III and Class IIb implantable devices
  • December 31, 2028 for other Class 11b devices, Class 11a devices, and unclassified devices

Why the September 26, 2024 Deadline Matters for EU Medical Device Compliance

Although extensions to comply with the new regulatory requirements for the devices in various classes are helpful for medical device manufacturers, September 26, 2024 is a crucial deadline for manufacturers to ensure they can obtain these extended transition periods. By this date, manufacturers must have submitted a signed agreement with a notified body for the extension to apply for the extension. In addition, there are conditions for manufacturers to qualify for the extension, that had to have been met by May 2024:

  • Continued compliance with MDD/AIMDD (regulations preceding the MDR 2017/745)
  • No significant changes in design or intended purpose
  • No unacceptable risk to health or safety
  • A formal application filed for an MDR conformity assessment to a notified body by May 26, 2024
  • Implementation of a quality management system compliant with Article 10(9) of the MDR by May 26, 2024

The ideal situation is that medical device manufacturers have met the above prerequisites by the corresponding deadlines, in order to do what’s needed next to obtain the transition extension. However, manufacturers with legacy devices that may have missed these deadlines are encouraged to move quickly to comply with the Regulation (EU) 2017/745 as soon as possible (if feasible and realistic), ascertain if their devices qualify for any exemptions, and/or at the very least, contact notified bodies as soon as possible to discuss their situations and identify any next steps available.

Assuming your quality management system is compliant and you have filed your MDR conformity assessment with the relevant notified body by the required deadlines above, the next section will provide you with additional ideas on how to prepare for the September 26, 2024 deadline.

Steps to Achieve EU MDR Compliance Before the Deadline

Companies selling medical devices in the EU should take the following actions now to achieve compliance by September 26, 2024.

  1. Assess Your Medical Device Portfolio

    • Identify which devices are considered “legacy” under the MDR.
    • Review the risk classification of each device to understand and identify applicable regulatory requirements.

  2. Develop a Transition Strategy

    • Create a timeline for transitioning all devices before their respective deadlines. For earlier transition deadlines, prioritize high-risk devices (Class III and Class IIb implantables).

  3. Ensure Your Quality Management System is MDR-Compliant

    • Implement or update your QMS to be MDR-compliant by May 26, 2024.
    • Conduct internal audits to verify compliance.

  4. Prepare Documentation

    • Review and update your technical documentation for all devices.
    • Ensure clinical evaluation reports are up-to-date and compliant with MDR requirements.

  5. Engage with the Relevant Notified Body and Obtain Your Written Agreement by September 26, 2024

    • Work towards securing a written agreement with a Notified Body by September 26, 2024.

  6. Align your Processes: Monitor Device Changes

    • If you haven’t already done so, implement a robust change management process to track any design or intended purpose changes.
    • Assess the impact of changes on MDR compliance.

  7. Stay Informed

    • Regularly check for updates from the European Commission.
    • Work with vendors like QAD who stay abreast of changes that impact medical device, biotechnology and pharmaceutical manufacturers.
    • QAD regularly updates their software process maps to align with regulatory changes to facilitate your speed-to-market.

  8. Train Employees

    • Conduct comprehensive training sessions on MDR requirements and company-specific procedures.
    • Ensure all relevant staff understand the new timelines and compliance requirements.

  9. Review Your Supply Chain

    • Assess the impact of extended transition periods on your supply chain.
    • Communicate with suppliers and distributors about the changes, and make sure they are prepared.
    • A robust Supplier Relationship Management (SRM) system can help you track supplier compliance and facilitate supplier onboarding.

  10. Prepare for Post-Market Surveillance

    • Enhance your post-market surveillance systems to meet MDR requirements.
    • Ensure your Enterprise Resource Planning (ERP) system has robust track and trace capabilities.
    • Implement processes for ongoing benefit-risk assessment and reporting.
Robyn Coward
Robyn Coward is the Life Sciences Director at QAD. With 21 years of experience in product commercialization, Robyn has spent the last 11 years focused on the global life sciences markets, particularly in the imaging, laboratory diagnostics, and healthcare IT segments. In her role, Robyn monitors and reports on the trends impacting QAD's life sciences customers. She is a member of several industry organizations including the Medical Device Contract Manufacturing Trends Group, Life Sciences Technology and Compliance Group, and the Healthcare Businesswomen's Association. Robyn also participates in various Biocom Institute activities, and enjoys residing in the San Francisco Bay area, one of the world's top hubs for biotechnology, pharmaceutical and medical device development and manufacturing, where she can see exciting and emerging healthcare innovations before they hit the market.

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