High-quality, active implantable medical devices, such as implantable hearing aids, Cardiac pacemaker systems, Implantable infusion pumps, Cochlear implants and accessories, Insulin pumpsand Retinal 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:
With product tests and certifications from TÜV Rheinland:
We conduct conformity assessments based on Annexes 2, 3, 4, and 5 of the Directive 90/385/EEC on active implantable medical devices.
1. Voluntary pre audit
We will base the scope of the pre audit on your wishes. You receive a report that can provide you with important information for the preparation of the certification audit.
2. Product Design Examination
We define the scope of this audit based on your needs. We provide you with an audit report listing potential areas of improvement.
3. Initial Certification Audit
If the audit results are positive, the decision on granting certification and issuing the certificate will be performed by a person independent from the audit (certifier). This is followed by a regular surveillance audit every 12 months and a recertification every 5 years. Additional unannounced audits will be performed in irregular intervals.
Did you know? Neither a decision on granting certification nor any change of the certificate status (e.g. maintaining, renewing, refusing, suspending, restoring or withdrawing certification as well as expanding or reducing the scope of certification) is made by a single person! We always apply the four-eyes principle: The evaluation of the audit team/product expert is followed by a separate review and decision.
5. 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).
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.
The company DuPontTM has transitioned Tyvek® 1073B and Tyvek® 1059B to a new manufacturing process. Legal Manufacturers of medical devices who use this material in their products should assess the packaging and sterilization processes to evaluate the impact on their devices. TÜV Rheinland LGA Products GmbH developed the following guidance to show in which case the significant change for CE0197 labeled devices is reportable. We would therefore recommend to send us the Significant Change Notification Form back.
Further information can be found under : www.dupont.com
|Flowchart according to Class III Medical Devices and AIMD of Tyvek® Medical Packaging Transition Project||137 KB||Download|
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