On 13 December 2016, the French Decree 2016-1716 implementing the French Law 2016-41 modernising the French healthcare system (“French Law 2016-41”) was adopted. This Decree provides important information concerning the obligation for manufacturers of implantable medical devices and manufacturers of Class III medical devices to submit a summary of product characteristics to the French Agency for the Safety of Health Products (“ANSM”).
Obligation to provide a summary of product characteristics to the ANSM
French Law 2016-41 introduces a new Article L. 5211-4-1 to the French Public Health Code which provides that manufacturers of certain medical devices or their representatives must communicate a summary of product characteristics to the ANSM when the medical device is put into service in France.
The obligation for which the Decree provides is limited in scope to manufacturers of implantable medical devices and Class III medical devices. The Decree also underlines that this new obligation applies to manufacturers and their European Authorised Representative or distributors.
Content of the summary of product characteristics
The new Article R. 5211-66-1.-II of the French Public Health Code implemented by the Decree provides that the summary of product characteristics must include the following elements:
- Information concerning the medical device, the legal manufacturer and, where relevant, the European Authorised Representative including:
- Name or trade name of the medical device, classification and related classification rules applied;
- Name and address of the legal manufacturer and the European Authorised Representative and the relevant contact details;
- Date of the summary of product characteristics and version number
- Information concerning the use of the medical device including:
- Intended purposes of the medical device, contraindications and targeted patients population;
- Place of the medical device in the diagnostic and therapeutic strategy;
- Targeted users of the medical device and the related training which might be required.
- Description of the medical device including:
- principles of operation;
- reference to prior versions of the medical device and description of the relevant changes;
- description of accessories, other medical devices, other products or substances intended to be used with the medical device;
- description or list of the different versions of the medical devices which would be available on the market;
- reference of the standards applied by the manufacturer.
- Information concerning the clinical evaluation and post-marketing surveillance of the concerned device.
- Summary of the clinical evaluation for the medical device;
- Post market surveillance plan for the medical device.
The Decree provides that the summary of product characteristics must be submitted by electronic means to the Director-General of the ANSM at the time the medical device is put into service on French territory.
Additional administrative work for manufacturers
This new obligation, applicable from 1 July 2017, will require manufacturers of implantable medical devices and manufacturers of Class III medical devices to disclose to the ANSM a number of elements which are contained in the Technical File of their medical devices and which are normally not communicated to the Agency unless the manufacturer receives a specific request for the ANSM. This additional administrative work should, therefore, be anticipated by medical devices manufacturers before placing their products on the French market.
This new obligation could even become burdensome for manufacturers which would be required to immediately inform the ANSM if an already-submitted summary of product characteristics is substantially modified.