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The actual Directives (… MDD)
Depending on the type of Medical Device, a specific directive is valid:


The future Directives
At this moment, the Euroapean Commission is working on a new set of Regulations.
The adoption is planned for 2014, being effective from 2015 to 2019
The first proposals are ready, together with some guiding documents:

For more details see the website of the European Commission: MDD: Revision


The Standards (ISO, IEC)
THe general standards can be found via ISO - Standards Catalogue / ICS: 11.040.01
  - 11   : Healthcare technology /
  - 040 : Medical Equipment
  - 01   : Medical Equipment in General
(ordering is possible via TAB: Revision Information)


The Guidance’s (MedDev’s)
To get an overview of the most interesting MedDev’s but also to prevent for not linking to the latest MedDev's. I have decided to list the most interesting MedDev's in an table, with a general link to the MedDev’s themselves.

Category MedDev nr. MedDev Title 
2.1 Scope 2.1/1 Definitions of Medical Devices, Accessory and Manufacturer 
  2.1/5 Medical Devices with a measuring function
  2.1/6 Qualification and Classification fo stand alone software 
2.4 Classification 2.4/1  Classification of Medical Devices 
2.7 Clinical 2.7/1 Clinical Evaluation 
  2.7/4 Clinical Investigation 
2.12 Market
        Surveillance
2.12/1 Vigilance System (incl. MIR, FSCA, Trend Report)
  2.12 Post Market Clinical Follow-up studies
2.14 IVD 2.14/1 Classification Borderline products: MD / IVD
Category: ISO