Team Notified Body: New MDR Training Session Available for April 2024
2 February 2024
MDCG 2024-2: Process & Timing to Add, Amend, Obsolete New EMDN Codes
7 February 202426 May 2024 Deadline: Conditions
May 26, 2024, is a critical date for the MDR transition.
The MDR transition was not a blanket extension until December 2027-2028. Certain requirements have to be met.
For example, MDD/AIMDD legacy devices must have an application lodged with a Notified Body by 26 May 2024. If this does not occur, then the device ceases to be a legacy device and may no longer be placed on the market.
The next key deadline is 26 September 2024. By this date, you must have a signed agreement in place with the Notified Body.
This impacts more than just the EU. If you leveraged your CE Marking for registration/compliance in other markets, you may need to stop marketing there as well. For example:
Further, legacy devices must continue to comply with the MDD; meet the MDR’s market surveillance, post-market surveillance, vigilance, and registration requirements; and not present an unacceptable risk to the health or safety of patients, users, or other persons.
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What does it mean to “lodge an application”?
Below is a summary from the EU Commission’s Q&A document. Please review the Q&A document for the full overview.
A lodged application is not just an email to a Notified Body, requesting a proposal. It is a formal application, generally submitted after some initial correspondence/discussion with the Notified Body, and includes some level of technical documentation.
In principle, the application should include the items from the applicable conformity assessment route, e.g., MDR Annex IX, “Chapter I – Quality Management System” and “Chapter II – Assessment of the Technical Documentation”.
However, the EU Commission recognizes that the timeframe between lodging an application and being audited may be a very long time. Therefore, the application does not need to include all technical documentation for each device covered by the application.
At a minimum, the application should:
- Clearly identify the devices being transferred to the MDR.
- Allow the Notified Body to assess the classification and chosen conformity assessment procedure.
- Include a timeline for possible submission of the individual technical documentation.
- Include a plan, agreed upon by the Notified body and manufacturer, for submission of the relevant technical documentation needed for the conformity assessment activities.
- Include the documentation on the manufacturer’s Quality Management System (QMS).
- Per the Commission’s Q&A document, this is how manufacturers verify they have met the requirement to implement a QMS compliant to MDR, Article 10(9). This is also required by 26 May 2024.
Please check with your preferred Notified Body for their application requirements. The process may differ across Notified Bodies. For example, below are the processes for:
Further Reading
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