Active Implantable Medical Devices Directive (AIMD)

European Market Access for Implantable Medical Devices

Medical device industry is one of the most competitive industries in the world, with a very limited average life span of a product, before an improved version is launched. Manufacturers must comply with the Medical Device Directives in order to sell into the EU marketplace. As a notified body, we conduct conformity assessments for your active implants and provide you access to the European market with a CE Certification. EU Directive 90/385/EEC defines the requirements for Active Implantable Medical Devices (AIMD) on the European market.

Depending on your needs, we can:

  • Evaluate your product design and audit your quality management system
    (Annex 2).
  • Conduct an EC type examination and review quality assurance in the
    manufacturing stage (Annex 3).
  • Perform EC verification (Annex 4).

Benefits at a Glance

Partnering with TÜV Rheinland offers you:

  • A single source that guides you through all of the necessary requirements for launching your products in the European market
  • A competitive advantage - Boost your customers' confidence in the quality and reliability of your active implants
  • Association with a recognized and trusted global brand
  • A network of highly qualified experts in Medical Devices

Our Services for Active Implantable Medical Devices

We conduct conformity assessments based on Annexes 2, 3, 4, and 5 of the Directive 90/385/EEC on Active Implantable Medical Devices.

Example of a conformity assessment procedure based on Annex 2 for AIMD:

Product Design Examination
Our experts review all of the design documentation (design dossier) for compliance with Directive 90/385/EEC. Upon successful completion of the examination, our certification body issues an EC design examination certificate.

Optional Preliminary Audit
Scope of this audit is defined based on your needs. At the completion of the preliminary review, we issue an audit report listing potential areas for improvement.

Initial Certification Audit

Phase 1
We audit your company on-site to determine whether you are eligible for certification, or analyze all the required information about the company. For example, this phase might include a review of your quality management documentation. We then provide you with a report on the results.

Phase 2
Based on the audit plan provided prior to the audit, we determine whether your processes comply with the requirements of the relevant directives and standards. We pay special attention to whether your products meet these requirements. Each relevant production facility is included in the audit. The audit team comprises of experts in your product category or categories. A detailed audit report is provided at the end of the audit.

Certificate/Approval
If the results of the audit are positive, you receive an approval for the conformity assessment procedure. This is followed by a regular surveillance audit every 12 months and recertification every 5 years.

Declaration of Conformity
Upon successful completion of the audit, you can issue the declaration of conformity for your products and market them with the CE mark, including the ID of the notified body (0197).

Conformity Assessment based on Annex 2

For active implantable medical devices, each product needs to be audited by a notified body. Most manufacturers choose the conformity assessment procedure in Annex 2. This procedure also includes an examination of your design dossier. Since examining design dossiers is time consuming, we recommend manufacturers of active implantable medical devices to contact a notified body well in advance of the planned product launch.

Product Examples

  • Implantable hearing aids
  • Cardiac pacemaker systems
  • Implantable infusion pumps
  • Cochlear implants and accessories
  • Insulin pumps
  • Retinal implants