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Changes over time for: Division 3.


Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Status:
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
3.The manufacturer must also undertake to keep available for the competent national authorities:U.K.
[3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.] U.K.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;
[3.2. For devices intended for clinical investigations, the documentation must contain: U.K.
a general description of the product and its intended use,
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to 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 7.4 of Annex I, 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,
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
the results of the design calculations, and of the inspections and technical tests carried out, etc.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.
The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.]
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