A Guide to Grace Periods and PSURs under MDR

In our MDR article series, we’ve briefly touched on the concept of a grace period. This is a transition period of three years for manufacturers to comply with the MDR.

• State of the Art and MDR Compliance: What Manufacturers Must Know
• Counting down to Medical Device Regulation (MDR)

Here we look at whether this requirement has been changed or modified under the Medical Device Regulation (MDR) and the specifics around Periodic Safety Update Reports (PSURs). 

MDR and Grace Periods

Manufacturers must ensure they meet certain requirements to take advantage of the extension of the MDR transitional period. This includes that they must have filed a formal application with a Notified Body and that they already have an MDR-compliant Quality Management System in place, as the deadline for this was May 26, 2024. 

As of now, the transition periods for different device classes transitioning to the EU MDR are defined as follows:

• 26 May 2026 for Class III implantable custom-made devices
• 31 December 2027 for Class III and implantable Class IIb devices
• 31 December 2028 for non-implantable Class IIb and lower-risk devices
• 31 December 2028 for Class I devices that are categorized as a higher class under the MDR

Important deadline on September 26, 2024, in accordance with EU MDR 2017/745.
 

​What happens on this date:​
• Last day for manufacturers to sign a written agreement with a notified body to benefit from extended transitional periods
• Marks the end of the possibility to continue placing Legacy certified devices on the market (unless meeting conditions for extended transitional periods)
• Devices not compliant with MDR and not meeting conditions for extended periods must be withdrawn from the market. 

For general inquiries related to MDR Certification Services and to support on your journey towards the MDR transition, reach out to our team of experts at Intertek Medical Notified Body. 

PSURs under MDR

A PSUR is a comprehensive document that provides an ongoing assessment of the risk-benefit balance of a medical device. It should include safety data, an analysis of that data as well as any proposed actions based on the findings. Under MDR, the submission of PSURs is mandated to ensure that any emerging risks are identified and mitigated promptly. 

Looking at Article 86, Point 3 of the MDR, which states, "For devices other than those referred to in paragraph 2, manufacturers shall make available to the notified body involved in the conformity assessment and, upon request, to competent authorities." From this there still may be a question around whether manufacturers must provide PSURs even for products classified as Class I? 

In our opinion, they do not have to supply these as they are not mandatory for products designated as Class I. However, manufacturers of class I devices do not have to prepare a PSUR; instead, they should prepare a Post-Market Surveillance Report (PMSR) as detailed in Article 85. 

As the regulatory landscape continues to evolve, it's crucial for manufacturers to stay abreast of the latest developments and seek expert guidance when navigating the complexities of MDR compliance. 

In the next in our MDR blog series, we look deeper into the nuances of PSURs to ensure you are able to navigate this aspect of regulatory compliance seamlessly. 

And don't forget to stay tuned for our upcoming installment, where we'll explore the critical topic of Cyber-security Requirements, providing you with essential insights to navigate this aspect of regulatory compliance with confidence. 

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