What information needs to be provided to the Competent Authorities prior to initiation of a clinical study with a product without a CE-Mark or outside of the labelling of a CE-Marked product? What basic information about the medical device needs to be maintained on-file for inspection by the Competent Authorities?
Council Directive 90/385/EEC
(5 September 2007)
STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
1. The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section 2.
2. The statement shall comprise the following information:
2.1. For custom-made devices: -/-
2.2. For devices intended for clinical investigations covered in Annex 7:
- data allowing the devices in question to be identified,
- the clinical investigation plan,
- the investigator’s brochure,
- the confirmation of insurance of subjects,
- the documents used to obtain informed consent,
- a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
- the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
- the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
- the place, date of commencement and duration scheduled for the investigations,
- a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
3. The manufacturer shall undertake to keep available for the competent national authorities:
3.1. For custom-made devices, -/-
3.2. For devices intended for clinical investigations, the documentation shall also contain:
- a general description of the product and its intended use,
- design drawings, manufacturing methods, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits, etc.,
- the descriptions and explanations necessary for the understanding of the said drawings and diagrams and of the operation of the product,
- the results of the risk analysis and a list of the standards laid down in Article 5, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements of the Directive where the standards in Article 5 have not been applied,
- if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
- the results of the design calculations, checks and technical tests carried out, etc.
The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in 3.1 and in the first paragraph of this section.
The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.
4. The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.
5. For custom-made devices, -/-