On December 13, 2016, the French Decree 2016-1716 implementing French Law 2016-41 and modernizing the French healthcare system was adopted. This Decree provides important information concerning the obligation of manufacturers of implantable devices and Class III medical products to submit a product characteristics summary to the Agency for the Safety of Health Products (ANSM) subsidiary of the French Component Authority. The new registration requirement will be effective beginning July 1, 2017.
I. Mandatory Registration Requirement: Product Characteristics Summary
French Law 2016-41 introduces a new Article L. 5211-4-1 to the French Public Health Code which mandates that manufacturers of certain medical devices, or their authorized representatives, must communicate a summary of defined product characteristics to the ANSM when the medical device is operational in France.
This obligation is limited to manufacturers of implantable medical devices and Class III medical devices in accordance with Annex IX of the European Medical Device Directive 93/42 (MDD), as amended. The Decree also states that the new obligation applies to manufacturers and their European Authorized Representative or distributors.
II. Required Inclusion Information for the Product Characteristics Summary
Article R. 5211-66-1-II of the French Public Health Code, implemented by the Decree, mandates that the summary of product characteristics must include the following details:
A. Information concerning the medical device, the legal manufacturer and – when relevant – the European Authorized Representative, including:
- Name or trade name of the medical device, device classification and related classification rules applied
- Name and address of the legal manufacturer, the European Authorized Representative and relevant contact details
- Date of the summary of product characteristics and version number
B. Information concerning the use of the medical device, including:
- Intended purpose(s) of the medical device, contraindications and targeted patient population(s)
- The role the medical device plays within the diagnostic/therapeutic strategy
- Targeted users of the medical device, and details related to any training which might be required
C. Description of the medical device, including:
- Principles of operation
- Reference to prior versions of the medical device, and description of any relevant changes
- Description of accessories, other medical devices and/or other products/substances intended to be used with the medical device
- Description or list of the different versions of the medical device that are available on the market
- Reference of the standards applied by the manufacturer
D. Information concerning the clinical evaluation and post-market surveillance of the referenced device, including:
- Summary of the clinical evaluation pertaining to the medical device
- Post-market surveillance plan for the medical device
The Decree mandates that the summary of product characteristics must be submitted electronically to the ANSM General Director. This information is to be received no later than the date that the medical device is operational within any French territory.
III. Additional Administrative Work Expected for Manufacturers
The new French registration requirement, effective July 1, 2017, will require device manufacturers, authorized representatives, or European importers of implantable devices and/or Class III products to disclose to the ANSM a number of details that are contained in an organization’s Design Dossier. Previously, the information contained within a Design Dossier was not shared with a Competent Authority unless the manufacturer received a special request to disclose such information.
Another consideration is the potential for the new requirement to become burdensome for manufacturers, who will be required to immediately inform the ANSM if an already-submitted summary of product characteristics is substantially modified.
The additional administrative registration process that this mandate imposes should be carefully anticipated by medical devices manufacturers before placing products within the French marketplace or other European markets. This is especially important in light of other expected, significant EU MDD regulatory changes that will be quickly forthcoming.