In March 2023, EU 2023/607 was published to amend the Regulation to extend the transitional provision therein. The main purpose of the extension is to allow Notified Bodies to have more time for reviewing legacy devices and issuing CE-Certificates within the EU MDR framework.
This change also allows for additional time to submit MDR applications for certain device classifications, provided manufacturers meet a defined set of conditions that are required to qualify for the extension.
Let’s recap the extension times and transition deadlines for different types of legacy devices. Depending on the different risk classes of devices, the following new transition periods apply.
Transition Deadline > Affected Devices
- 26 May 2026 > Custom-made implantable devices in class III
- 31 December 2027 > Higher-risk devices This includes Class III devices and Class IIb implantable devices, excluding sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors
- 31 December 2028 > Medium and lower risk devices This includes other class IIb products, class IIa products and products of classes ls, lm, lr.
- No extension > Class I devices (other than ls, lm, lr)
The sell-off period for existing products remains in effect as previously specified in the Medical Devices Regulation.
Let’s also not forget that the required date for compliance with the EU MDR is 26 May 2024, regardless of the extended transition period for certain legacy devices. These new transition dates should, therefore, not be viewed as “get out of jail free cards”. The extended transition time comes with conditions which need to be fulfilled by 26 May 2024.
Two great resources to examine are the Notified Body position papers and the “TEAM-NB Position Paper: New MDR Transition Timelines and Notified Body Capacity”. These discuss the transition deadlines provide observations and suggestions for manufacturers around successfully meeting regulatory requirements that can help manufacturers maintain continuity in supplying devices to patients who need them.
“Many manufacturers are not applying for MDR certification in time and a lot of the received applications contain incomplete MDR technical documentation”. – TEAM-NB Position Paper: New MDR Transition Timelines and Notified Body Capacity
There are typically 4 tasks you need to complete, if not more if requested by your Notified Body:
- Apply with your Notified Body for the new transition time.
- Complete a set of technical documents for all representative products, including all relevant objective evidence.
- Agree with your Notified Body on an MDR audit date. (your QMS needs to be in compliance with the MDR)
- Complete the General Safety and Performance requirements (GSPR) to demonstrate compliance and declare the safety of your device.
It is late, but perhaps not too late. As an MDR consultant, I often see manufacturers either in jeopardy of missing the required compliance date of 26 May 2024, or in some cases, they are ignoring it altogether. My recommendation is to put an emphasis on the transition PROGRAM. That is, construct and execute a plan for going about meeting the new requirements, taking guidance from informed sources like those cited in this article. Keep in mind that your QMS must be in compliance with the MDR. Noncompliance with the amended regulation means you will not be able to sell your legacy device after 26 May 2024.
MEDVACON Life Sciences LLC can assist you with your MDR, an extension, or integral activities within your Quality System, including:
Gap Analysis
Internal Audits
GSPR development
Risk Management
DHF remediation
