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Medical Products (MDD)

Medical Products Help Saving Lives

In a field that is characterised 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 authorised to inspect your medical products and in vitro diagnostics and can assist you with the right conformity evaluation procedure for CE marking - 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 EN ISO 13485, EN ISO 9001, or EN ISO 15378.

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 authorisations
  • Avoid faulty developments and minimize the risk of returns with our assistance in competent development
  • 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 say

Conformity Proof Via The CE Mark

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

  • 93/42/EWG for Medical Devices (MDD)
  • 90/385/EWG for Active Implantable Medical Devices (AIMD)
  • 98/79/EG for In-vitro Diagnostic Devices (IVDD)

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, an evaluation of a design dossier, or an audit for 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

Definition of a Medical Product

Medical products are separate or combined-use instruments, apparatus, appliances, software, materials, or other objects that are exclusively designed for diagnostic or therapeutic use. This also includes any installed software that ensures the medical device functions flawlessly when used for the following purposes:

  • Diagnosis, protecting, monitoring, treatment, or prevention of diseases
  • Diagnosis, monitoring, treatment, prevention, or compensation of injuries or handicaps
  • Examination, replacement, or change of the anatomic structure or physiological procedure
  • Contraception, where the intended effect in or on the human body cannot be attained through simple metabolism, but via the use of pharmacological or immunological substances, and where the efficiency of which can be supported by such substances

Definition of Accessories

An object that is not a product in its own right, but has been specially developed by the manufacturer for specific use in combination with another product.

Essential Requirements - Annex 1

EU authorities state that medical products can be traded on the European market as long as they fulfil the basic requirements of the Medical Device Directive (MDD, 93/42/EWG), Annex I.

The manufacturer declares conformity of a medical device with the basic requirements by labelling every single product with the CE mark.

The basic requirements represent the objective of the MDD and the device should comply with them prior to the launch of the product on the EU marketplace.

They specifically cover:

  • Safety
  • Technical performance
  • Medical performance of the product

Based on the conformity assessment procedure of the MDD it should be demonstrated that technical and safety related requirements are fulfilled.

Whereas medical performance is made evident by compliance with the clinical study specifications of the MDD.

A product does not necessarily have to fulfil all basic requirements, only those applicable to the product and which are directly related to the specified intended use of the product.

Nevertheless, the manufacturers are obliged to fulfil the basic requirements, but the method how they do this, is up to them.