Book II: Medical devices, in vitro diagnostic medical devices and other products and articles regulated in the interests of public health

The bodies responsible for carrying out the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé published on the Agency’s website. Authorisation is given for a maximum period of five years and specifies the tasks for which it is granted. Bodies applying for authorisation must send…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing this, if the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, he will be deemed to have refused authorisation on expiry of this seven-month period. This period…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may grant, under the conditions laid down in Article R. 5211-55 and Article 4 of Implementing Regulation (EU) No 920/2013, a renewal of authorisation or an extension of its scope to an authorised body which so requests.

I.-The approved bodies must comply with the following obligations: 1° The approved body, its director and the personnel responsible for carrying out the assessment and verification operations may not be the designer, manufacturer, supplier, installer or user of the devices they inspect, nor the authorised representative of any of these persons. They may not intervene either directly or as agents of the parties involved in these activities, in the design,…

The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall carry out surveillance and ongoing monitoring of the bodies it has authorised to ensure ongoing compliance with the obligations listed in Article R. 5211-56, under the conditions laid down in Article 5 of Implementing Regulation (EU) No 920/2013.

Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation has been granted.

The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medical devices and active implantable medical devices manufactured from tissues of animal origin mentioned in Article R. 5211-23-1. If, in the light of this verification, the Director General of the Agence nationale de sécurité du médicament et des produits…

If an accredited body ceases to fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after the head of the body has been asked to present his observations. This decision specifies the conditions under which the files held by the organisation are made…

Before examining the application for assessment, the approved body will ensure that the file includes in particular : – the general characteristics of the applicant, such as company name, name, address, legal status ; – a precise description of the scope of the assessment requested and a reference to the directives and national provisions transposing them.

The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.