Annulment of Decree No. 2016-1716 that was published in the Official Journal of the French Republic on December 13th 2016
05/02/2018
Decree n°2016-1716, regarding the « medical device characteristics summary » was annuled by the French Council of State on april, 26th 2016, due to the absence of its legal basis. This decree, do you recall, came into effect on July 1st 2017, and imposed that all class III and implantable medical device manufacturers and their authorized representatives, had to submit a medical device characteristics resume to the ANSM (French Competent Authority).
And as a good news never comes alone, this annulment is retroactive. It’s as if the decree had never existed !
You already submitted your mMD characteristics summary to the ANSM ? If you are able to prove its additional cost, you can demand redress. You were sanctioned for non execution of the Decree ? You can ask for restitution of the fine.
However, you should be aware that France had only anticipated the entry into force of the EU 2017/745 Regulation on may 26th 2020. Article 32 of the MDR introduces an equivalent of the medical device characteristics summary : the summary of safety and clinical performance, for which the content expected is pretty much identical.
So in fine, it’s a good thing if you already have the document.
12/15/2016
Decree No. 2016-1716 was published in the Official Journal of the French Republic, in pursuance of article 147 of Law No. 2016-41 regarding the modernization of the French healthcare system. This decree makes it mandatory for manufacturers of implantable or Class III medical devices (or their representatives) to complete a medical device characteristics summary.
What changes
Prior to publication of Decree No. 2016-1716, the medical device characteristics summary concerned Class IIa, IIb, III and implantable medical devices. It was optional and confidential.
However, starting from July 1, 2017, whenever an implantable or Class III medical device is put into service on French national territory, a medical device characteristics summary must be sent electronically to the chief executive of ANSM, the French Competent Authority that regulates medical products. This Decree details the information that must be contained in a medical device characteristics summary.
Note: custom-made devices are exempt from this requirement.
Caution
ANSM will have to be immediately notified by the manufacturer (or its representative) of any modifications to the information contained in a registered summary. Manufacturers who fail to provide a summary to ANSM may be subject to a penalty of €150 000.
Consequences
The medical device characteristics summary must be written clearly, such that non-professional users will be able to easily understand the information contained within it. Manufacturers will need to submit a draft of their medical device characteristics summary to the notified body (NB) in charge of their product’s conformity assessment. The NB will then approve and register it in EUDAMED, the future European data bank. According to Article 26 of the European Union’s proposed Medical Device Regulation, the summaries will be made available to the public via EUDAMED.