Active Implantable Medical Devices Directive
Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)
The Active Implantable Medical Devices Directive (with the official reference number 90/385/EEC) applies only to active implantable devices. For a device to be classified as an ‘active implant’, it must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure.
The Active Implantable Medical Devices Directive has a a first objective the harmonisation of the regulatory environment across the European Economic Area, and at the same time, it enables the free movement of goods within the European Union.
The Directive sets out the essential safety requirements in terms of function, sterility, material compatibility, marking, ‘user’ instructions, design documentation and CE marking but also include requirements for type approval, production quality management, clinical investigation and manufacturer registration.
Which Products Are Covered By The Active Implantable Medical Devices Directive?
The Active Implantable Medical Devices Directive (90/385/EEC) covers medical devices that match the definition provided in the directive:
Which Products Are Not Covered By The
Active Implantable Medical Devices Directive?
Excluded from the Active Implantable Medical Devices Directive are:
How to Comply with the Active Implantable Medical Devices Directive:
For all active implantable medical devices, the involvement of a Notified Body is obligatory.
European Harmonised Standards Related to Active Implantable Medical Devices Directive:
The Latest Related Blog Posts About the Active Implantable Medical Devices Directive:
French Notified Body Initiates Product Recall for Breast ImplantsMarch 5, 2014
Notified Bodies ExplainedNovember 21, 2013
European Commission Publishes Recommendation on the Audits and Assessments Performed by Notified Bodies in the Field of Medical DevicesSeptember 26, 2013
List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) UpdatedMay 7, 2012
- Machinery Directive – 2006/42/EC
- Low Voltage Directive – 2014/35/EU
- EMC Directive – 2014/30/EU
- Medical Devices Directive – 93/42/EEC
- Personal Protective Equipment Directive – 89/686/EEC
- Construction Products Regulation – Regulation (EU) No 305/2011
- Pressure Equipment Directive – 97/23/EC
- REACH – Regulation (EC) No 1907/2006
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- ATEX Directive – 2014/34/EU
- Toy Directive – 2009/48/EC
- R&TTE Directive – 1999/5/EC
- Recreational Craft Directive – 94/25/EC
- Explosive for Civil Use Directive – 93/15/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Gas Appliances Directive – 2009/142/EC
- Lifts Directive – 1995/16/EC
- Pyrotechnic Directive – 2007/23/EC
- Measuring Instruments Directive – 2004/22/EC
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- What does CE certification cost?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
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- Notified Bodies: What Are They? What Is Their Role
- What is the CE marking process?
- What files / documentation must I keep?
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