Active Implantable Medical Devices
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