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EC
Declaration of Conformity to
In Vitro Diagnostic Medical Devices (98/79/EC) according
to Annex III of the IVDD Company
Name Company
Address declares that diagnostic reagents listed on the attached Device Schedule, classified as “all other IVD Medical Devices” according to Annex IX rules, conform to the relevant provisionsof the EC Council Directive 98/79/EC and are in accordance with Annex III of the IVDD,as implemented by the European Union's Medical Devices Regulations. (The
Company's name) agrees to develop, implement and maintain a documented
post-production experience monitoring process, including the notification of
reportable events under the European Medical Device Vigilance System Guidelines. (The
Company's name) confirms that no medicinal products/drugs are incorporated in
any device covered by the Device Schedule. The
Company has appointed M. Devices Group as our EU Authorised Representative of: Marlborough
House, Riding Street, Southport, PR8 1EW, United Kingdom Tel: +44 1704 544 944, Fax: +44 1704 544 050, E-mail: eurep@mdevices.net Signed by the Company's designated
representative: Name: Paul Shane Bennetts Title: Managing Director Date: Signed on behalf of (The Company's name): Name: (Name of the Company's Officer) Title: Date: |
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