Implementation of the Medical Device Regulation
Obligation of SPONSORS in accordance with Article 77
As the transition period will soon be ending and manufacturers will be required to comply with the new EU Medical Device Regulation, there will be stricter requirements regarding clinical testing and its documentation. One of these stricter requirements is laid out in Article 77 of the Medical Device Regulation.
Paragraph 5 of the article requires SPONSORS in future to prepare not only the clinical testing report but also a summary. The corresponding section of the regulation is worded as follows:
The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73.
At this time there are no requirements in terms of the content or scope of this summary. Alongside a range of other changes arising from the regulation, SPONSORS therefore have a duty to prepare documentation.
We would like to offer you our support in complying with this requirement. Our clinical research team has developed a template for a summary in accordance with Article 77 and is already using this in practice.