EU Regelgeving en richtlijnen

 

Medische Hulpmiddelen

MDD 93/42/EEC

MDD 2007/47/EC

 

MDR, EU verordening van 5 april 2017 betreffende medische hulpmiddelen 

MDR 2017/745

 

In Vitro Diagnoctics

IVD 98/79/EEC 

 

IVDR, EU verordening van 5 april 2017 betreffende medische hulpmiddelen voor In Vitro Diagnostiek 

IVDR 2017/746

 

Begeleidende documenten Medische Hulpmiddelen en IVD (MEDDEV) 

2.1 Scope, field of application, definition

MEDDEV 2.1/1 Definition Medical Devices, Accesoiries and Manufacturer

MEDDEV 2.1/2 Application of the Active Implantable Device Directive 90/385/EC

MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators

MEDDEV 2.1/3 Borderline, drug-delivery products and med. devices incoporating medicinal substances or human blood derivative

MEDDEV 2.1/4 Demarcation between MDD, EMC and PPE directives

MEDDEV 2.1/5 Medical Devices with a measuring function

MEDDEV 2.1/6 Quantification and classification of stand alone software

 

2.2 Essential requirements

MEDDEV 2.2/1 EMC requirements

MEDDEV 2.2/3 "Use by" date

MEDDEV 2.2/4 Conformity assessment of IVF and ART products

 

2.4 Classification of Medical Devices

MEDDEV 2.4/1 Classification of medical devices

 

2.5 Conformity assessment procedure

MEDDEV 2.5/3 Subcontracting - Quality Systems related

MEDDEV 2.5/5 Translation procedure

MEDDEV 2.5/6 Homogeneous badges

MEDDEV 2.5/7 Conformity assessment of breast implants

MEDDEV 2.5/9 Medical Devices containing rubber latex

MEDDEV 2.5/10 Guideline for Authorized Representatives

 

2.7 Clinical investigation, clinical evaluation

MEDDEV 2.7/1 Clinical evaluation

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 Clinical investigation

 

2.10 Notified bodies

MEDDEV 2.10/2 Designation and monitoring of notified bodies

 

2.11 Products using materials of biological origin

MEDDEV 2.11/1 Risk management is animal tissue products susceptible for TSE

 

2.12 Market surveillance

MEDDEV 2.12/1 Guidelines on a Medical Devices vigilance system

MEDDEV 2.12/2 Post market clinical follow up studies for Medical Devices

 

2.14 In Vitro Diagnostics

MEDDEV 2.14/1 IVD Medical Device borderline and classifications issues

MEDDEV 2.14/2 IVD products for research use only

MEDDEV 2.14/3 Supply of instructions for use and other information for IVD

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

 

2.15 Others

MEDDEV 2.15/2 Committees/Working Groups for the implementation of the MDD