View source for Document:GBR Directive 93/42/EEC 11-Oct-2007

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|DocReference=GBR  Directive 93/42/EEC  11-Oct-2007
|DocValidityArea=GBR
|DocScopes=MD
|DocName=Directive 93/42/EEC
|DocVersion=11-Oct-2007
|DocStatus=Current
|DocType=Legal act
|DocLanguage=EN
|DocDescription=COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993
concerning medical devices
|DocRestricted=No
|DocSubmittedBy=Florian Adragna
|DocContributors=
}}</noinclude>

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|reference=GBR  Directive 93/42/EEC  11-Oct-2007
|validity_area=GBR
|scopes=MD
|doc_name=Directive 93/42/EEC
|version=11-Oct-2007
|status=Current
|doc_type=Legal act
|language=EN
|description=COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993
concerning medical devices
|official_link=https://www.legislation.gov.uk/eudr/1993/42/data.xht?view=snippet&wrap=true
|restricted=No
|submitted_by=Florian Adragna
|contributors=
}}

<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1]] || MD || ANNEX X
2.1 || EN || 2. Clinical investigations 2.1. Objectives The objectives of clinical investigation are: — to verify that, under normal conditions of use, the performance of the devices conform to those referred to ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9]] || MD || Article 9 || EN || Classification 1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX. 2. In the event of a dispute between the manufacturer and ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2.]] || MD || Annex VIII
1. ; 2. || EN || STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative must draw up the ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4.]] || MD || Article 15
1. - 4. || EN || Clinical investigation 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X]] || MD || Annex X || EN || CLINICAL EVALUATION […] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001]] || MD || Article 15
6. - 7. || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2]] || MD || Annex VIII
1. ; 2. ; 2.2 || EN || STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative[F8 established in the ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002]] || MD || Article 15
6. - 7. || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7]] || MD || Annex X
2.3.7 || EN || 2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation.
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2]] || MD || Annex X
2.2 || EN || 2.2.Ethical considerations Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last ...
|}
</noinclude>