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

  • Medical Devices  (MDD)                                Directive 93/42/EEC
  • Active Implantable Medical Devices (AIMDD)    Directive 90/385/EEC
  • In Vitro Diagnostic Medical Devices (IVDD)      Directive 98/79/EEC

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)

  • ISO-13485      : QMS for Medical Devices
  • ISO/TR-14969 : Guidance on ISO-13485
  • ISO-14971      : Risk Management
  • IEC-62304       : Software Life Cycle
  • IEC-62366       : Usability Engineering
  • ISO-19011      : Auditing

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
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