New requirement to provide ANSM with summary of characteristics for medical devices
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From 1 July 2017, manufacturers of a medical device and their authorised representatives, and distributors directly supplying medical devices to users, must electronically submit a summary of the characteristics of the device (SCD) to the General Director of the National Agency for Medicines and Health Products Safety (ANSM) when the medical device is put into service on the French market.
This requirement was introduced by the Law on the Modernisation of the Healthcare System (Article 147) and implemented by Decree No 2016-1716 of 13 December 2016, which specifies the content and procedures for submitting the SCD.
The requirement to submit an SCD applies to implantable medical devices and Class III medical devices other than custom-made devices.
The SCD must be submitted for each trade name and must contain information relating to:
- The identification of the device (trade name, risk class, SCD date, and so on) and of the manufacturer or authorised representative.
- The use of the device (medical indications, target population, role of the device within the diagnostic and therapeutic strategy, adverse effects, and so on).
- The description of the device (including its functioning or the description of accessories and products intended to be used in combination with it).
- The clinical assessment and monitoring of the device after launch (summary of the clinical assessment's results and systematic review of data collected in the context of the EC declaration of conformity).
Any significant modification to the information contained in the SCD must be reported to the ANSM without delay.
Non-compliance with the submission requirement is subject to a EUR 150,000 fine.
This post was originally co-authored by Audrey Aboukrat.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2017 Issue (Thomson Reuters).