Regulatory Affairs

Regulatory Affairs

Technical Documentation MDR/IVDR

Creation of Technical Documentation for Medical Devices

Many manufacturers perceive the creation of Technical Documentation as a necessary evil. If you don't act carefully in this process, you risk time-consuming and costly follow-up questions and additional charges.

Technical Documentation MDR/IVDR – What is Technical Documentation anyway?

What is Technical Documentation anyway?

The Technical Documentation for Medical Devices based on Annexes I, II, and III of the Medical Device Regulation with the integration of optional parts for international approvals serves the purpose of conformity assessment. A structure is shown in Annex II of the MDR. The Technical Documentation is requested by your Notified Body for evaluation before the audit or required for approval outside the EU.

With the introduction of the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Regulation (EU) 2017/746, the scope of the required contents changes significantly. Additionally, there are products that under the MDR/IVDR suddenly need the involvement of the Notified Body.

The three most frequently asked questions when creating the Technical Documentation:

  • What are the additional requirements for Technical Documentation according to the MDR?
  • Is there a format template or a kind of sample structure that can be used as a guideline?
  • Is Clinical Evaluation/Performance Evaluation needed?

The most common problems encountered when creating the Technical Documentation:

Many manufacturers are suddenly confronted with very high requirements by the Notified Body, which has accepted the previous documentation without hesitation.

Or you are a Class I manufacturer or manufacturer of IVDs who will soon have to involve a Notified Body in the conformity assessment procedure and now have to deal with the requirements of a Notified Body/Authority for the first time. A growing variety of Medical Devices has made it more difficult to keep track of which Technical Documentation is still up to date or which can even be summarized under certain circumstances. There are many questions and problems concerning Technical Documentation, especially when converting from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). We have a solution: The qtec Aktenfuchs!

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

qtec as your partner

It is not necessary, nor helpful, to submit all the documents "that you have". Technical Documentation only contains documents that are needed and explicitly requested.

There is no mandated structure for the Technical Documentation. However, there are requirements for this structure, which are also described in Annex II of both regulations.

However, there are formats, such as the STED format, which can be used. However, it is not wrong to create your own structure as long as it fulfills the requirements in Annex II.

Depending on

  • in which target areas a company operates,
  • which portfolio is available and
  • how dynamic the product development of a manufacturer is,

various solutions for structuring and formatting Technical Documentation to keep the maintenance effort as low as possible and to avoid anxiety.