Doporučující a interpretační dokumenty MEDDEV

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Oblast

Pokyn MEDDEV

2.1
Aplikace směrnic a definice

MEDDEV 2.1/1 Definitions of "medical devices", "accessory" and "manufacturer"

MEDDEV 2.1/2 rev.2  Field of application of directive "active implantable medical devices" 

MEDDEV 2.1/2.1  Field of application of directive "active implantable medical devices"

MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative

MEDDEV 2.1/4  Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009

MEDDEV 2.1/5  Medical devices with a measuring function

MEDDEV 2.1/6  Qualification and Classification of stand alone software

2.2
Základní požadavky

MEDDEV 2.2/1 rev.1  EMC requirements

MEDDEV 2.2/3 rev.3  "Use by" - date

MEDDEV 2.2/4  Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

2.4 Klasifikace ZP

MEDDEV 2.4/1 rev.9  Classification of medical devices

2.5
Proces posuzování shody

General rules

Quality assurance. Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-Global Harmonization Task Force website)

MEDDEV 2.5/3 rev.2  Subcontracting quality systems related

MEDDEV 2.5/5 rev.3  Translation procedure

MEDDEV 2.5/6 rev.1  Homogenous batches (verification of manufacturers' products)

Conformity assessment for particular groups of products

MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants

Evaluation of medical devices incorporating products of animal origin. (See MEDDEV 2.11/1 rev.2 )

MEDDEV 2.5/9 rev.1  Evaluation of medical devices incorporating products containing natural rubber latex

MEDDEV 2.5/10  Guideline for Authorised Representatives

2.7
Klinické zkoušky a klinické hodnocení

MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies Appendix 1: Clinical evaluation on coronary stents)

MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation notification

MEDDEV 2.7/3 Clinical investigations: serious adverse event reporting  - SAE reporting form

MEDDEV 2.7/4 (Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

2.10 Notifikované osoby

MEDDEV 2.10/2 rev.1  Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

Annex 1, Annex 2, Annex 3, Annex 4

2.12 Následný dozor a systém vigilance

MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System                                                    

I. MEDDEV 2.12/1 rev.8 - Latest Version Forms

MEDDEV 2.12/rev.7 MIR and FSCA are still valid

Active PDF forms

How to use FSCA and MIR forms

Manufacturer Incident Report - MIR

Field Safety Corrective Action

MIR and FSCA xml files  

Others forms and templates

Field Safety Notice Template

Trend Report

Periodic Summary Report

II. Device Specific Vigilance Guidance

DSVG 00 Introduction to Device Specific Vigilance Guidance

DSVG 01 Cardiac Ablation Vigilance Reporting Guidance

MEDDEV 2.12/2 rev.2  Post Market Clinical Follow-up studies

2.13 Přechodné období

MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009

2.14
IVD

MEDDEV 2.14/1 rev.2  Borderline and Classification issues. A guide for manufacturers and notified bodies

MEDDEV 2.14/2 rev.1  Research Use Only products

MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10

MEDDEV 2.14/4  CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

2.15
Ostatní

MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives