AIMDD


Active Implantable Medical Devices

1. Active Implantable Medical Devices Directive

1.1. Definitions

The AIMD are typical medical devices in the meaning of the MD directive, for which the high level of risk caused by malfunction or total failure is typical aspect. For many type of implants the consequence of mentioned defects could be fatal. This is a reason for creating separate 90/385/EEC Directive on technical requirements on active implantable medical devices.

The medical device is any instrument, material or other article (including controlling software) intended by the manufacturer for the purpose of:
   Diagnosis, prevention, monitoring, treatment or alleviation of human disease
   Diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or      handicap,
   Investigation, replacement or modification of the anatomy or of a physiological process
   Control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Active medical device means medical device using for its functioning a source of electrical energy or any source of power other than that directly generated by the human body or gravity

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 in this place after the procedure;

Custom-made device means AIMD specifically made for an individual patient;

Device intended for clinical investigation means AIMD intended for clinical research and trials;

1.2. Scope of the AIMD Directive

The AIMD Directive relates to all active implantable medical devices. However, the directive defines terms 'active implant' quite broadly, and not only the implant itself must bear the CE Marking, but also the associated accessories and software without which the implant cannot be properly functional.

It is necessary to say, that the Directive applies only to active (electrically powered) implantable devices. All non active implantable medical devices are covered under the General Medical Devices Directive 93/42/EEC.

Examples of products which are the AIMD medical devices include:
   Implantable neurostimulators
   Hearing-aids
   Implantable insulin infusion pumps
   Cardiac pacemakers
   Defibrillators
   and accessories to above mentioned examples

1.3. Categorisation of AIMD

The Directive makes differentiation between “classical” AIMD implants, custom made devices and AIMD for clinical investigation. Only “classical” AIMD are subject of CE marking, the further two not. However their must fulfill requirements that relate to them, including appropriate conformity assessment procedure.

1.4. Essential requirements and supplier registration:

As in the case of general MD Directive, also the AIMD manufacturer or his authorized representative in the EU has the obligation to register at the appropriate authority itself together with the products introduced on the market. The manufacturers from third countries must have in EU authorized representative, if they wish to sell products in so ever EU Member State.

The essential requirements in the AIMD directive are basically the same as for devices classified as class III under the Medical Devices Directive and these can be divided into two categories:
  a) The general requirements (as in the MD directive)
  b) and the specific requirements that apply to the design and construction of the active      implant. These requirements focus mainly on the technical safety, biocompatibility and      sterility of the active implant. Another requirements are material compatibility, marking,      'user' instructions, design documentation etc.

1.5. Vigilance procedures

The unwished accidents related to improper function of AIMD shall be notified at national authority.

1.6. Conformity Assessment procedures

The prescribed methods of conformity assessment (see Article 9 of the AIMD Directive) are related to high risk in connection to AIMD application and use.

1) In the case of AIMD than are not custom-made nor intended for clinical investigations,     the manufacturer shall choose one from following procedures:
  a) either follow the procedure set out in Annex 2 ( Complex Quality Assurance      system );
  b) or apply procedure in Annex 3 ( EC type-examination ) together with:
   - (i) either with the EC verification set out in Annex 4
   - (ii) or with the Production Quality Assurance described in Annex 5

2) In the case of custom-made devices, the manufacturer must draw up the declaration    according to Annex 6 before placing each device on the market (without CE).
3) In the case of devices intended for clinical investigations, the manufacturer is obligated    to notify the national authority 60 days in advance. CE marking does not apply.

The flow diagram of conformity assessment processes leading to CE marking of the AIMD than are not custom-made nor intended for clinical investigations is presented on the next page.

The compliance to harmonized standards is accepted as the presumption of fulfilling of essential requirements and conformity to the AIMD Directive.

Conformity assessment flow chart

For AIMD devices not custom made nor intended for clinical evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:

    (a) the procedure in Annex 2 (Complex quality assurance) or
    (b) the procedure in Annex 3 (EC type-examination) coupled with:
      (i) the EC verification set out in Annex 4, or
      (ii) the production quality assurance set out in Annex 5.

After writing of EC Conformity Declaration, the manufacturer is obligated to affix the EU conformity mark CE on each AIMD product or its packaging, eventually an accompanied leaflet.

1.7. ITC AND ITS FOREIGN PARTNER'S ROLE IN THE AIMD FIELD

The notification scope of ITC includes all kinds of Active implantable medical devices. Therefore, possibilities of ITC/foreign partner co-operation are large in this AIMD field, based on the necessary Notified Body assistance at all procedures related to commercially offered AIMD devices.

1.7.1. Voluntary certification
In the voluntary field, the quality system evaluation and certification according to standard EN ISO 13485 is the possible task, that could be performed together with the obligatory conformity assessment procedure.

1.7.2. Notified Body's participation
All classical AIMD introduced on the market are before CE marking subject of conformity assessment tasks performed by Notified Body. On the flow chart is visible, that the manufacturer has the chance of choice between different procedures.

It is highly recommended, to offer to manufacturer especially the procedure described in the Annex 2 (Full Quality Assurance - Module H).

This module H is also preferred by many manufacturers, as it is applicable for more different products. In addition, the procedure is nearly identical to the full quality assurance of MD and IVD medical devices.