Active and Non-Active Medical Devices

Conformity Assessment for Your Medical Devices

When it comes to medical devices, quality and safety are features gift that must be guaranteed by law .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 Directive 93/42/CEE. 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
  • Share technical choices with an experienced and internationally recognized Body

Our Services for Your Medical Devices

  • Conformity assessment procedure based on Annexes II, III, IV, V, and VI of the 93/42/CEE Directive
  • Certification as a "tested medical device"
  • Examination of technical documentation for compliance with Annex VII of the Medical Device Directive
  • Checks of compliance with harmonized standards, for example: EN 60601 or EN 12182

Certification process for the Conformity Assessment based on Medical Device Directive

1. Starting comparison

2. Product testing activities (eg. Electrical safety and electromagnetic compatibility tests) and document analysis (Technical File evaluation)

3. Certification Audit

During the audit, we will evaluate company processes, production facilities and medical devices for compliance with the directives related harmonized standards. The inspection team is always made up of experienced and qualified auditors for the sector.

4. Issue CE Certificate
Given the positive results, will be issued the certificate CE on the assessment procedure followed. To ensure the maintenance of the requirements checked initially, there will be a verification of annual audit.

Classification

Every Manufacturer must define the intended purpose of their medical devices and classify them based on Annex IX of Directive 93/42/EC on medical devices. The directive distinguishes between different risk classes: class I - class Im, class Is, class IIa, class IIb, and class III.

Classification may be based on the following criteria identified in Annex IX of Directive 93/42/CEE:

  • Duration of use
  • Invasiveness
  • Active or non-active medical device
  • Use in the central circulatory or nervous system
  • Use of materials of animal or human origin

Depending on the classification of your medical device, be imposed specific certification procedures for conformity assessment. TUV Rheinland can accompany you for the following assessment modules: Annexes II, III, IV, V, and VI.