The EU medical device directives
To remove trade barriers between member states and build a single market that ensures the free movement of persons, services, capital and products such as medical devices, the European Commission has established three EU directives that replace the former national approval systems and align the rules for placing these products on the market.
- Active Implantable Medical Devices Directive (AIMD) 90/335/EEC — applies to active implantable medical devices such as cardiac pacemakers and implantable insulin pumps. AIMD took effect on 1 January 1993, with a transition deadline of 31 December 1994 and mandatory application from 1 January 1995.
- In Vitro Diagnostic Medical Devices Directive (IVD) — applies to in vitro diagnostic medical devices such as blood cell counters and pregnancy testing devices.
- Medical Devices Directive (MDD) 93/42/EEC — has a very broad scope covering almost all medical devices other than active implantable devices and in vitro diagnostic devices, including non-active devices (dressings, single-use products, contact lenses, blood bags, catheters, etc.) and active devices (nuclear magnetic resonance scanners, ultrasound diagnostic and therapeutic devices, infusion pumps, etc.).
Applicable regulation
- In Vitro Diagnostic Medical Devices Directive (IVD)
- Active Implantable Medical Devices Directive (AIMD) 90/335/EEC
- Medical Devices Directive (MDD) 93/42/EEC
Products covered
Active medical devices
High frequency electrosurgical units
Ultrasonic lithotripters
Nuclear magnetic resonance (NMR) systems
Surgical lights
Operating tables
Non-active medical devices
Syringes
Medical gauze
Medical gloves
Stents
Documents required
Company profile, and the name and contact details of the European authorised representative
Product instruction manual and sales literature
Product overview and a table of differences between models
Product images, including outer packaging, inner materials and all markings
List of raw materials
Copies of quality-related certificates, where available
Harmonised standards applied to the product, or other standards
Risk analysis conclusions, preventive measures and evaluation of potential risks
Packaging and labelling — packaging material description and medical and warning markings; labels (nameplates)
Test reports from product registration — biocompatibility testing; physical performance and chemical testing such as material reports or RoHS reports
Clinical evaluation — clinical test reports and relevant literature; clinical use overview and authoritative opinion
The full production process, from component procurement to sale of the finished product