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Active and Non-Active Medical Devices

Active und Non-Active Medical Devices

Conformity Assessment for Your Medical Devices

When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European market!

Benefits at a Glance

Product tests and certifications by TÜV Rheinland let you:

  • Communicate your high standards of quality
  • Boost your customers' confidence in the quality and reliability of your medical devices
  • Offer your customers essential guidance in choosing a product

Our Services for Your Medical Devices

  • Conformity assessment procedure based on Annexes II, III, IV, V, and VI of the
    Medical Device Directive
  • Certification as a "tested medical device"
  • Examination of your technical documentation for compliance with Annex VII of
    the Medical Device Directive
  • Testing of your medical devices for compliance with harmonized standards, for example: EN 60601 or EN 12182

Example of a Conformity Assessment Procedure based on MDD, Annex II

  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. Technical Documentation
    We determine the number of technical documents to be reviewed as specified in he NBOG 2009-4 norm. We then review your technical documentation for compliance with the Medical Device Directive.
  3. Product Design Examination (for Class III only)
    Our experts examine your entire product design documentation (design dossier) for compliance with Directive 93/42/EEC. If the design review is successful, our certification body issues an EC design examination certificate.
  4. Initial Certification Audit
    Stage 1
    Assessment of the readiness of your company for certification through an on-site audit or an evaluation of all necessary information about the company. This includes for example the review of the QM documentation. You will receive a related report about this.

    Stage 2
    Prior to the audit you will receive an audit plan. During the audit, company operations will be examined regarding how the requirements of the applicable directive and standards are fulfilled. In the process, we will particularly assess the conformity of the products with the requirements. All relevant production sites will be included in the audit. An expert in the relevant product category(ies) will be part of the audit team. You receive an audit report on completion.
  5. Certificate
    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.
  6. 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).

Contact

Get in contact with us!

Get in contact with us!