Medical Device Directive Mdd

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MDCG 2021-5 Guidance on standardisation for medical devices

ec.europa.eu

Medical Devices Medical Device Coordination Group Document MDCG 2021-5 1 MDCG 2021-5 Guidance on standardisation for medical devices April 2021 This document has been endorsed by the Medical Device Coordination Group ... Directive 93/42/EEC on medical devices4 (MDD), applicable from 1 January 1995 until

Devices, Medical, Directive, Medical device, Mdcg

Technical Documentation and Medical Device Regulation

www.bsigroup.com

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD)

Devices, Medical, Regulations, Technical, Directive, Documentation, Medical device, Technical documentation and medical device regulation

General Safety and Performance Requirements (Annex I) in ...

www.bsigroup.com

Device Directive (MDD, 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD, 90/385/EEC), so too is compliance with the ‘General Safety and Performance Requirements (SPRs)’ in establishing conformity with the recently published Medical Device Regulation – EU Regulation 2017/745 (MDR). The Regulation’s date of publication

General, Performance, Devices, Medical, Requirements, Safety, Directive, Medical device, Medical device directive, General safety and performance requirements, Device directive

Commission Factsheet for Class I Medical Devices

ec.europa.eu

Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance ... the definition of an “accessory for a medical device” (MDR Article 2(2)), the MDR applies and all of the requirements applicable to devices will apply.

Devices, Medical, Directive, Medical device

Guideline on the quality requirements for drug-device ...

www.ema.europa.eu

130 repeals Directive 93/42/EEC (the Medical Device Directive, MDD). 131 In addition, this guideline should be read in conjunction with all other relevant directives and 132 regulations, the European Pharmacopeia and all relevant Commission, ICH and CHMP guidelines, Q&A

Guidelines, Devices, Medical, Quality, Requirements, Directive, Medical device directive, Guideline on the quality requirements

Reporting of design changes and changes of the quality system

meddev.info

5.2 Changes to EC-approved medical devices design/type (including software) (MDD Annexes II, 4.4 and III; IVDD Annexes VI-4.2 and V, respectively): a) Reportable change: - Changes to the medical device included computer software (e.g. new functionalities, new algorithms for

Devices, Medical, Medical device

Are Your Labels EU MDR Compliant? - Medical Device …

qtspackage.com

13.1 Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users… 23.1(a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended