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Medical Products (MDD)

Medical Products (MDD)

Medical Products Help Save Lives

In a field that is characterized by fast-moving cycles of innovation, competence and quality are important factors for success. Place your trust in the experts at TÜV Rheinland. We are a notified body authorized to inspect your medical products and in vitro diagnostics and can assist you with the right conformity evaluation procedures for CE marks - meaning you can get your “driving license” for EU countries that little bit quicker. Upon request, we can also certify your quality management system in compliance with the EN ISO 13485, EN ISO 9001, or EN ISO 15378 norms.

Benefits at a Glance

With medical product audits and certification from TÜV Rheinland, you can:

  • Benefit from our international standing and founded experience when it comes to
    international authorizations
  • Avoid faulty developments and minimize the risk of returns with our competent
    development assistance
  • Boost confidence in the quality and safety of your products with the TÜV Rheinland brand
  • Take advantage of fast audit times and our extensive experience and competence
  • Make use of our diverse, one-stop-shop portfolio, as they sa

Conformity Proof Via The CE Mark

As a manufacturer of medical products, the CE mark helps document the conformity of your products with the following directives:

  • 93/42/EWG for Medical Products (MDD)
  • 90/385/EWG for active implantable medical devices (AIMD)
  • 98/79/EG for in vitro diagnostics (IVD)

TÜV Rheinland - "Notified Body"

Depending on the risk category of the product, you are required to commission a notified body to carry out an EG prototype audit, evaluation of a design dossier, or for auditing the quality management system. Together with you, we carry out the necessary conformity evaluation procedure for your products and company, meaning that you will receive your “driving license” for EU countries that bit quicker. On top of that, we can offer an audit of your medical products for specific or voluntary market requirements.

Our Services

As a notified body, we carry out the following European homologation processes:

  • Conformity evaluation of active and inactive medical products
  • Conformity evaluation of active implantable medical devices
  • Conformity evaluation of in vitro diagnostics

Services as a Certified Institute for Quality Management Systems

  • EN ISO 9001 certification
  • EN ISO 13485 certification for medical product manufacturers
  • EN ISO 13485 certification for the preparation of medical products
  • EN ISO 15378 certification for primary packing material

Additional Audits

  • Ergonomics and user compatibility of medical products
  • Tested medical products
  • Lab products used in healthcare
  • Chemical audits, ROHS
  • Components

Contact

Get in contact with us!

Get in contact with us!