The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial in ensuring patient safety and granting access to markets.
As the industry adapts to significant regulatory changes, recent extensions to MDR deadlines bring both relief and unforeseen challenges. It is essential to understand the urgent need for action, as the consequences extend beyond individual manufacturers and affect the entire system.
This article aims to shed light on the potential risks to market access if the current deadlines are not met. We also examine the main reasons for delays. Not only manufacturers but also Notified bodies, who play a crucial role in this regulatory framework, are encouraged to simplify procedures and provide essential guidance.
MDR Deadline Extension: False Sense of Security Causing Delays
The MDR became applicable on 26 May 2021 and entered into application gradually. However, the transition from the former directives to the MDR and IVDR was much slower than expected, resulting in impending shortages of medical devices in the EU.
An amending regulation (EU) 2023/607 was published in March 2023, extending the transition periods for the MDR with the new “translational” provisions for MDR. Manufacturers are given more time to bring their products into compliance with the MDR. However, to benefit from this deadline extension, manufacturers must submit their MDR application as soon as possible.
According to Article 120 (3c) of MDR, manufacturers must apply by May 26, 2024, to benefit from the extended transitional period, with September 26, 2024, as the deadline to sign a written agreement and transfer appropriate surveillance to an MDR Notified Body. Certification processes must be finalized in 2027 or 2028 depending on the classification of the device.
This approach ensures that manufacturers work towards meeting the requirements of the new regulation and gives Notified Bodies insight into the availability of technical documentation, allowing them to plan accordingly.
The downside is that this extension has created a sense of security and even led to a delay in the MDR process for some manufacturers. In this way, notified bodies face another bottleneck for the upcoming deadlines. With an expected increase in applications as May 2024 is approaching, Notified Bodies, operating on a first-in-first-out basis, cannot guarantee that applications made last minute will be reviewed in time to ensure a contract is in place before September 2024.
Manufacturers must also keep in mind that to make use of the transition timelines, there are several conditions they have to fulfill:
- Only those devices that are transitioning to the MDR benefit from the longer transition timelines.
- No significant changes in the design or intended purpose of the devices are allowed.
- Devices may not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.
- A quality management system according to Article 10 (9) must be put in place no later than 26 May 2024.
If a manufacturer has not signed a contract with a Notified Body by September 2024, they put their own certification at risk.
Monitoring Device Availability in the EU Market
Regulators are concerned about the lack of visibility on which devices are (or will be) submitted to Notified Bodies and which devices will no longer be available on the European market, possibly resulting in shortages for certain applications.
The EU Commission therefore launched a 36-month study in December 2022 to support the monitoring of the availability of medical devices (including in vitro diagnostics) on the EU market. All manufacturers and authorized representatives are invited to respond to the survey to gain visibility in the future availability of medical devices in the European Market.
MDCG and Team-NB Call for Timely Compliance
Limited Progress in Terms of Submissions and Certificates
In November 2023, the Medical Device Coordination Group (MDCG), which is an expert group representing competent authorities of the EU countries, updated its position paper to call manufacturers and Notified Bodies for timely compliance with MDR and IVDR requirements.
This call follows from a Notified Bodies survey last updated in June 2023 that shows limited progress in terms of applications submitted and certificates issued both under MDR and IVDR. The issue is not new and was already addressed by Team-NB (The European Association for Medical Devices of Notified Bodies) in their position paper of August 2023.
Typical Causes for Delays and a Call to Avoid Them
Both MDCG and Team-NB acknowledge the efforts of manufacturers but urge them to strengthen their efforts to transition as soon as possible and not to delay submissions further. Both organizations revealed once more in their surveys that important causes of delay are due to incomplete applications and lack of complete technical documentation submission.
Problems identified by economic operators are the lengthy procedure with increased cost and lack or insufficient number of qualified staff needed to enforce all the requirements.
Notified Bodies to Streamline Procedures and Provide Guidance
MDCG calls not only on the manufacturers but also on the Notified Bodies to take action. They suggest Notified Bodies streamline their procedures and improve their activities in terms of transparency, timelines, predictability, and consistency. Notified Bodies need to provide manufacturers with regulatory guidance and technical information on how to apply for the conformity assessment procedure.
Next Steps: Urgent Actions to Ensure Timely Compliance
1. Accelerate MDR Application Submissions
As a manufacturer, you must act quickly to submit your MDR applications before the crucial deadline of May 26, 2024. Submitting applications early is paramount, as the first-in-first-out basis may pose challenges for last-minute submissions. The extended transition period is conditional on a rapid start to the compliance process, ensuring a smooth transition and avoiding unnecessary delays.
2. Adhere to Transition Timelines and Requirements
Manufacturers transitioning to the MDR must carefully consider the conditions, such as refraining from significant design changes and implementing a quality management system by May 26, 2024. Failure to meet these criteria will jeopardize eligibility for longer transition timelines.
3. Participate in EU Commission’s Device Availability Study
To address concerns about device visibility and potential shortages in the European market, all manufacturers and authorized representatives are strongly encouraged to participate in the EU Commission’s 36-month study. Responding to the survey will contribute to gaining crucial visibility into the future availability of medical devices.
4. Address Causes of Delays
Acknowledging the challenges highlighted by MDCG and Team-NB, manufacturers should address common causes of delays, including incomplete applications and insufficient technical documentation. Strengthening efforts to overcome these obstacles is crucial for a streamlined compliance process.
Economic operators facing challenges due to lengthy procedures and lack of qualified staff can seek support from experienced teams, such as QbD. Enlisting specialized assistance can expedite application requests and ensure comprehensive technical documentation submissions.
Need help to gain timely MDR/IVDR compliance?
QbD Group can help you get started and ensure you meet all the requirements needed to take advantage of the transition timelines. We can help you set up your Quality Management System according to ISO 13485 and MDR. We can work with you to define a strategy to comply with regulations for European and other global markets.
QbD Regulatory can help you set up your technical documentation. We can help you select a Notified Body and act as a contact for Notified Body, Competent Authority, and so on. QbD can provide on-demand external support to expand your internal capabilities whenever you need it.
Don’t hesitate to contact us for help, whether it’s coaching your team, reviewing or fully writing your technical documentation, or assisting with your contacts with Notified Bodies.