Submitting Technical Documentation under the MDR?
Submitting Technical Documentation?
Read the Team-NB Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (5 Oct 2022, version 1)
The most common reasons for delays in Technical Documentation reviews by notified bodies are:
- Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities.
- Lack of Cohesive Structure of Technical Documentation. The information is presented within the Technical Documentation but is difficult to locate.
Also, consider the following:
- that abbreviated or partial test reports are not considered acceptable.
- to provide the label or labels on the medical device in the languages accepted in the Member States where the device is envisaged to be sold. This includes Device or Product labeling, Sterile packaging labeling, Single unit packaging labeling, Sales packaging labeling, and Transport packaging labeling.
- that if electronic IFU will be utilized, ensure compliance has been clearly outlined and evidence included to demonstrate compliance with all relevant aspects of Regulation 2021/2226.
- to provide the protocols, data, and results for usability studies when compliance with the relevant European standards (EN62366 and EN60601-1-6) is claimed.
The time spent reading and applying the guidance will ultimately pay off. The full text can be found here.
Read the Team-NB Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (5 Oct 2022, version 1)
The most common reasons for delays in Technical Documentation reviews by notified bodies are:
- Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities.
- Lack of Cohesive Structure of Technical Documentation. The information is presented within the Technical Documentation but is difficult to locate.
Also, consider the following:
- that abbreviated or partial test reports are not considered acceptable.
- to provide the label or labels on the medical device in the languages accepted in the Member States where the device is envisaged to be sold. This includes Device or Product labeling, Sterile packaging labeling, Single unit packaging labeling, Sales packaging labeling, and Transport packaging labeling.
- that if electronic IFU will be utilized, ensure compliance has been clearly outlined and evidence included to demonstrate compliance with all relevant aspects of Regulation 2021/2226.
- to provide the protocols, data, and results for usability studies when compliance with the relevant European standards (EN62366 and EN60601-1-6) is claimed.
The time spent reading and applying the guidance will ultimately pay off. The full text can be found here.