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Active Implantable Medical Devices (AIMD)

Active Implantable Medical Devices (AIMD)

Safe Implants

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:

  • 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
  • you boost your customers' confidence in the quality and reliability of your active implants
  • you 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

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

  • 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
    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.

4. Certificate/Approval
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).

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.

Product Examples

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

Significant changes of Tyvek® material

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 of the significanct changes of Tyvek® Medical Packaging

pdf Flowchart according to Class III Medical Devices and AIMD of Tyvek® Medical Packaging Transition Project 137 KB Download

Offer

Any questions? Would you like an individual, non-binding offer? Then write to us now. We will respond to your request as quickly as possible.

pdf Questionnaire for the preparation of an offer for medical products 181 KB Download
pdf General Terms & Conditions 62 KB Download
pdf Testing & Certification Regulations 120 KB Download

Significant changes of Tyvek® materials

Significant Change Notification Form

Guidance

More information

Unannounced audits

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