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:
- Proposal Medical Devices (Proposal-MDD), combination of the old MDD and AIMDD
- Proposal In Vitro Diagnostic Medical Devices (Proposal-IVDD)
- Communication Letter
- Summary of changes e.g.:
- New Essential Requirements
- Un-announced audits
- New product Classification
- Regulation i.s.o. Directive
- FAQ
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 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 |