a capability within quality management

MDR / IVDR Transition

In the coming years, medical device manufacturers who are not compliant to MDR/IVDR are facing a period of transition to new regulatory requirements on their development and manufacturing processes (QMS) as well as their device documentation.

This transition will involve a thorough assessment and update of the QMS and the device documentation to ensure compliance within different business areas such as post-market surveillance, UDI registration (Unique Device Identification), use of symbols on labeling, and redefined roles and responsibilities for all economic operators in the value chain.

Assistance for MDR/IVDR transition projects is among the core services offered by our quality management specialists, who possess extensive experience and in-depth knowledge within this special field of medical device development. Participated or managed more than 20 legacy product STED file submissions, all approved by the notified body (NB).

5 things to do to obtain full compliance with MDR or IVDR

Major challenge

In our experience, one of the major challenges of the MDR/IVDR transition is ensuring a dedicated project team with drive and motivation to run the project and setting the project on the right track from the start. This step is crucial to preventing obstacles and slowdowns from interrupting the progress of the project once it is running.

Another potential concern is the possibility of being confronted with unforeseen changes which require extra effort in terms of research, clarifying, or generating new data to support compliance with the new regulations.

Our quality management specialists can help you through the entire transition process using capabilities such as:

  • Identifying the gabs between current QMS/device documentation and MDR/IVDR requirement.
  • Identifying key SMEs (subject matter experts).
  • Managing scope control.
  • Solving ad hoc questions – (access to Technolution SME’s).
  • Facilitate the process of coming up with alternative solutions which can be supported by all business areas.
  • Adapting project plans to unforeseen changes.
  • Adding extra skills and work resources – (if required, at short notice, managing onboarding and project introduction).
  • Others.
MDR projects are often more intense and demanding than companies are planning for, and MDR submissions will often catalyze a global upgrade of the required documentation. When we engage in these projects, we are drawing on all our fields of expertise to meet the agreed deadlines and to ensure the appropriate level of documentation.
Nancy Fonskov
Head of Quality Management, Technolution​