Conformity Assessment for Medical Device Directive (MMD)

Conformity Assessment for the Medical Device Directive (93/42/EEC)

In order to gain access to the European market, medical device manufacturers must meet the requirements of the Medical Device Directive (MDD) and demonstrate compliance with appropriate regulations.

MDD testing with TÜV Rheinland provides your company the certification and documentation needed to expand into European markets and others around the world. Our team brings years of experience and in-depth knowledge of global standards to keep your products up-to-date and competitive in a diverse range of regulatory environments.

Benefits at a Glance

With more than 300 locations in 60 countries, we have a global view of the ever changing requirements of the most important markets in the world. In addition to the Medical Device Directive (MDD), we are a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices.

Partner with us for all of your compliance needs.

  • TÜV Rheinland's global presence means a quick return on investment
  • One partner for a comprehensive range of services
  • Customer satisfaction resulting in cost reduction
  • TUVdotCOM database for certification organization and storage

Our Services for the Medical Devices Directive (93/42/EEC)

Manufacturers must comply with the Medical Device Directive (MDD) in order to sell products into the European marketplace. As one of the few Notified Bodies for all directives relating to medical devices, we have the knowledge and expertise to help you navigate through the CE Marking process.

Basic requirements of the Medical Device Directive 93/42/EEC (MDD), Annex I

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

Our Comprehensive Services for Medical Device Manufacturers

Defining a Conformity Assessment Procedure

1. Technical Documentation
We determine the number of technical documents to be reviewed as specified in the NBOG 2009-4 norm. We then review your technical documentation for compliance with the Medical Device Directive.

2. 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.

3. Optional Preliminary Audit
Based on the scope determined by you, we conduct a preliminary review audit, and provide you with a detailed report highlighting areas where improvements can be made.

4. Initial Certification Audit

Phase 1
We audit your site to determine whether you are eligible for certification and/or analyze all the required information, e.g., your quality management documentation. A Phase 1 audit report will be issued with complete results.

Phase 2
Based on the audit plan provided prior to the visit, our audit team will review company processes, production facilities, and products for compliance with the directive and other standards. The audit team includes an expert in the relevant product category or categories. A detailed audit report will be provided at the end of the visit.

5. Certificate/Approval
If the results of the audit are positive, you receive an approval for the conformity assessment procedure. This is followed by a regular surveillance audit every 12 months, and a recertification audit every 5 years.

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).

CE Certification of Medical Devices

  • Active and non-active medical devices
  • Active implantable medical devices
  • In-vitro diagnostic medical devices