EU Guide: Importer Requirements under the MDR/IVDR
November 20, 2023
Team Notified Body: New IVDR Training Session
November 30, 2023Team Notified Body (NB) published a press release regarding their first MDR training for manufacturers, which occurred on 7 November 2023. It is available: HERE
The EU Competent Authority for Medical Devices (CAMD) met on 19-20 September 2023 and released a statement. It is available: HERE
Team NB Press Release
The training is organized and given by Team NB experts. The training topic was guidance on preparing technical documentation submissions: Team NB Best Practice Guide on MDR Technical Documentation
Attendee Breakdown
The training was fully booked: 79 attendees from 50 different organizations. The majority of attendees were SMEs.
MDR Transition Progress
Of the large manufacturers who attended the training, 100% have submitted at least one technical file to their Notified Body. Of the SMEs, 59% had submitted at least one technical file.
Large manufacturers have also transitioned more of their technical documentation to meet the MDR’s requirements than SMEs. E.g., only 8% of large manufacturers advised having transitioning 0-25% of their documentation to the MDR; however, 33% of SMEs advised they have transitioned 0-25% of their documentation.
Training Satisfaction Results
92% of attendees said the training met their expectations and 88% stated they would recommend it to others.
Future Trainings
Team NB have two additional trainings scheduled, if you would like to attend.
The training times are optimal for companies based in Europe (9:00 – 17:00 Central European Time). It would be more challenging for companies in the Americas or Asia Pacific to attend.
CAMD Meeting Statement
One of the main highlights of the document is regarding slow MDR transition progress:
“A follow-up of the applications numbers for MDR/IVDR and certificates issued under those regulations was also presented during this session, in the continuity of the work began at CAMD and now under the MDCG umbrella.
Those numbers showed not to be satisfying even 6 months after the regulation 2023/607 publication.
Competent authorities remind manufacturers to make the best possible use of the extra time granted by the transitional periods adapting their quality systems and devices to the MDR and IVDR requirements and submit complete applications to the notified bodies. All actors should join forces to avoid shortages of medical devices and the subsequent risks for patients.”
Guide: EU MDR Transition Extension
Deadlines, FAQs, Links to Templates and more
MDR Transition Deadline Reminders
Manufacturers of MDD/AIMDD legacy devices must complete the following:
By 26 May 2024:
- Have implemented a quality management system as outlined in MDR Article 10(9)
- Formally lodged an application with a Notified Body for the device
By 26 September 2024:
- Have a signed written agreement with a Notified Body, as per Section 4.3, second subparagraph, of Annex VII
If these conditions are not met, the device is no longer considered a legacy device, and therefore should not be placed onto the market after these dates.
