医疗器械CE认证一类产品的技术文件编写指南

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GUIDANCE NOTES FOR MANUFACTURERS

OF CLASS I MEDICAL DEVICES

Foreword

These guidance notes do not aim to be a definite interpretation of National Laws and/or regula-tions and are for guidance purpose only. This document should be read in conjunction with the relevant guidance listed in Annex A including the new guidance produced by MSOG for manu-facturers of custom made devices.

National Enforcement Authorities are bound by their own legislation and can only apply this guidance within the confines of their own law.

Introduction

The purpose of this document is to provide guidance to Class I medical device manufacturers or their Authorised Representative who place medical devices on the European Market under the manufacturer’s name, to help them to meet the requirements of national legislation that transposes the Medical Devices Directive 93/42/EEC (“MDD”) (latest amended by directive 2007/47/EC)

National legislation transposing the amendments introduced by directive 2007/47/EC will come into force 21st March 2010.

All medical devices must comply with the essential requirements established in Annex I of the MDD, ensuring that they do not compromise the health and safety of patients, users and any other person and perform as intended by the manufacturer. Medical Devices bear the CE mark to indi-cate their conformity with the MDD.

The manufacturer or Authorised Representative, shall follow the procedure referred to in

Article 11.5 and Annex VII and draw up the EC declaration of conformity required before placing their products on the market.

Definitions

Accessory – an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device (Ref.: MDD; Article 1 (2) (b))

Authorised Representative – Any natural or legal person established in the Community who, ex-plicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under the Di-rective. (Ref.: MDD; Article 14 (2) (j))

Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representa-tive in the European Union (Article 14 (2)). This will ensure that authorities have a single indi-

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