EU Guide: Medical Device Accessories under the MDR/IVDR
14 May 2024
EU Commission Survey: Notified Body Update on MDR/IVDR Certifications & Applications
17 May 2024The MDCG published the presentations from the MDCG “Extraordinary” meeting that occurred on 24 April 2024: HERE
Team Notified Body published results from their annual sector survey: HERE
MDCG Meeting Presentations
Results from recent surveys were published in the Redacted Update on the study on monitoring availability of medical devices.
If you have been following the Commission’s Notified Body capacity and MDR/IVDR surveys, you may be familiar with the first part of the presentation. However, it also includes data from the industry survey to manufacturers and authorized representatives.
- All the high-level results of the Manufacturer/Authorized Representative survey (slides 12-30)
- Self-reported average Notified Body costs under the MDR/IVDR (slides 27-28)
- Self-reported intent to discontinue medical devices in Europe (slides 29-30)
Slide 33 also notes a pilot survey to health service providers is planned May/June 2024.
Also published was the Competent Authority Task Force’s presentation on device shortages.
The presentation discusses the new proposal to require manufacturers to provide advance notice, if they expect any interruption to the supply of critical devices. In particular, Competent Authority actions related to it, including:
- Developing templates and a harmonized process
- Reaching a “clear and common understanding” of:
- “interruption of supply of a device”
- “reasonably foreseeable”
- “serious harm or risk of serious harm to patients or public health”
- Identify clear, understandable criteria that is able to characterize risk situations
- Have a central IT system “for easy input and sharing” of information
Per slide 6, some preliminary steps are targeted for completion before end of May 2024.
Team Notified Body Annual Survey
Team Notified Body (“Team NB”) published the results of its annual sector survey. This is an internal survey organized by Team NB, for Team NB members.
Below are some highlights from the survey:
- It shows the growth from only 18 Notified Bodies designated to the MDR in 2020, to 42 designated in 2023.
- The survey also provides how many ISO 13485 and MDSAP certificates have been issued, noting a 6% increase in issuance of ISO 13485 certificates.
- Growth in the number of Notified Body resources. However, “some of the technical resources have a lack of work following the request of some manufacturers to put their application on hold or delay responses”.
- The pre-audit completeness check shows 75% of the manufacturer’s technical documentation is missing half of the necessary information and therefore cannot start the assessment process.
To combat the last bullet point, Team NB recommends manufacturers refer to their Technical Documentation Best Practice guidance documents for MDR applications and IVDR applications.
Further Reading
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