AIMDD Introduction

Regulation

‘Active Implantable Medical Device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure

The active implantable medical device (AIMD) Directive 90/385/EEC was the first medical device directive and was implemented in 1993, applying only to active devices that are intended to be permanently implanted into humans. Notified Body certification is required for all products covered by this directive. 

Scope and Classification of Devices

The scope of the Directive applies only to active implantable medical devices and classifies them as either general, non-custom made AIMD or custom-made AIMD, with special provisions for devices that are only intended for clinical evaluation. Active implantable medical devices are usually electrically powered or are radioactive and examples include heart pacemakers, cochlear implants and radioactive seeds for cancer treatment.

Technical Documentation

Manufacturers must prepare technical documentation in a European language to support compliance of the device with the Essential Requirements of the Directive.

European Harmonized Standards exist for many types of devices and generic features and compliance by manufacturers is important, although not a legal requirement. EC guidance on technical documentation is available and should be followed by manufacturers wishing to CE mark. Clinical evaluation and risk management documentation is a mandatory part of this technical documentation.

Technical documentation will be assessed by a Notified Body as an EC Design Examination (Annex 2) or as an EC Type Examination (Annex 3).

Why choose Jiushun Enterprise Management?

Jiushun Management has determined the medical device consulting with adequate and systematic service as its major service since found on August, 1996. Jiushun has developed to be the one of the most qualified, widest service-providing and most customers in the Greater China (including Hong Kong, Macao andTaiwan).

We have provided the specialized service for more than 5,000 customers from the Greater China, UK, U.S.A, Japan, Singapore, Malaysia, etc. spreading all over the world, including 15 listed companies.