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Change of the procedure for the examination of Technical Documentations and Design Dossiers

Change of the procedure for the examination of Technical Documentations and Design Dossiers

04 Jan 2018

The Medical Device Directive 93/42/EEC requires the examination of the technical documentation by the Notified Body for Class IIa and IIb devices as well as design dossier documentation for Class III devices. The device selection criteria and the requirements of the examination have now been specified in greater detail. We remain committed to providing you with a modern and transparent examination process in the future. The most important changes for you are listed below.

Classification of findings:

Major non-conformity (Ma): Fulfilment of an essential requirement of the applicable Directive is not demonstrated.

Minor non-conformity (Mi):  Fulfilment of an essential requirement of the applicable Directive is not completely demonstrated.

Question (Q): The information submitted is not sufficient to make an evaluation. Further information is needed from the manufacturer to clarify the relevant aspect(s).

Remark (R): Note; does not constitute a deviation.

You will be informed about the date for submitting the documentation, the name(s) of the expert(s) and the date for the examination of the documentation. For new devices, the dates are to be agreed directly with the expert involved. 

3.1 A positive recommendation cannot be issued to the Certification Committee:
If non-conformities or questions emerge during the examination, you will receive a report stating them directly from the expert involved within a few days of the examination. The examination report will also contain the deadline for submitting the revised documentation along with the expected additional outlay for the supplementary examination. If you want us to carry out the supplementary examination, you need to confirm this by email. Please mark all changes clearly in the revised documentation.

3.2 A positive recommendation can be issued to the Certification Committee
If the examination is completed without deviations being identified or questions raised, the expert will forward the report directly to the certification body for review and the final decision. As usual, you will receive the decision letter about the successful examination of the technical documentation or design dossier.

The examination of a technical documentation or design dossier must be completed within 6 months of the date when you receive the first examination report. DEKRA will carry out at least one supplementary examination during these 6 months. The process will be concluded at the latest after 6 months or if you do not order the supplementary examination. The examination report will be forwarded to the certification body in its final form for review and the final decision. 

For new devices / altered or additional devices:
All non-conformities must be effectively resolved and all questions satisfactorily answered before the certification can be issued / altered / extended.

For products covered by the certificate:
If major non-conformities are not effectively resolved and assessed as such within 6 months the certification will not be maintained.
If the result of the potential hazard assessment for a major non-conformity shows a considerable risk to patients, users or third parties the certificate will be restricted with immediate effect.
Minor non-conformities must be effectively resolved and questions satisfactorily answered within 6 months. In exceptional circumstances the certification body may decide to maintain the certification subject to certain conditions being met.

Further remarks regarding the submission of documentation:

We accept documentation in both paper and electronic form. Please ensure that the documentation you submit is correct, coherent, relevant, up-to-date and complete. Include a structured table of contents detailing the revisions of the individual sections. Before submitting your documentation in electronic form, please make sure it matches the format and structure given in our document D-091-68 "Requirements for the format and structure of provided documentation".

If you require further information on the new procedure,

please feel free to contact us. If our auditors, experts and certifiers are not immediately available please contact the project co-ordinator responsible for you. They will forward your question and you will receive an answer as soon as possible. For any questions regarding sales, please contact our sales department directly by emailing: med.certification.de@dekra.com

Categories: Medizin Englisch, All News

DEKRA Certification

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