Active Implantable Medical Devices (AIMD)
High-quality, active implantable medical devices, such as pacemakers or cochlear implants, give patients new quality of life. EU Directive 90/385/EEC defines the requirements for active implantable medical devices on the European market. As a notified body, we conduct conformity assessments for your active implants.
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
With product tests and certifications from TÜV Rheinland, you:
- Meet all the necessary requirements for launching your products on the EU market
- Boost your customers' confidence in the quality and reliability of your active implants
- Benefit from fast lead times and our years of experience
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 AIMDs
- 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
We define the scope of this audit based on your needs. We provide you with an audit report listing potential areas of improvement.
- Initial Certification Audit
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.
Prior to the audit, you receive an audit plan. During 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 includes an expert in your product category or categories. We provide you with a detailed audit report.
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).
Our Recommendation: 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.
- Implantable hearing aids
- Cardiac pacemaker systems
- Implantable infusion pumps
- Cochlear implants and accessories
- Insulin pumps
- Retinal implants