Transition from MDD to MDR without losing focus or control
The MDKT manages your MDD-MDR transition process!
Q&A
Why is the project to update my Technical Documentation to MDR level constantly delayed?
In many cases, this is caused by missing Development results! It is not a problem of simply re-structuring the Technical Documentation! More and detailed information on how the product was developed and approved needs to be included. Your regulatory team does not cause the delay – it is a problem of missing development information and data that need to be collected. Some rework might be necessary to fill gaps in documentation.
Why do I have to Re-verify and Re-validate my products to meet MDR requirements?
You need to demonstrate that over the Product Lifecycle all changes (product, supply chain, regulation, and technical standards) have been evaluated! Critical changes need a risk assessment to re-verify or re-validate the changed product. This is the basis for a successful MDR certification.
Why is a single Product Risk Analysis not sufficient anymore?
The MDR and ISO 13485:2016 require an Integrated Risk Management Approach over the product lifecycle. This includes development, production, product and process changes, clinical data, and post-market data! Plan and prepare Risk Analyses to assess your internal and external processes.
Why do I need so much information from my Suppliers now, even though they are certified?
As a manufacturer of medical devices, you are responsible for outsourced processes. Depending on your supplier relationship you need to make sure that inputs and outputs of your supply chain are defined, documented, and controlled. You must control the transfer of your development results to outsourced productions in the same way as for an internal production! For external development processes, you need to document processes with your supplier and release development planning and results. You need to document your responsibility for your supply chain and actively manage your suppliers and any changes!
My Technical Standard has been updated. Do I need to re-test or re-develop my device?
It depends. If the new technical specifications or test parameters have been included, you may need to re-develop or re-test your device. In any case, you need to evaluate and document the validity of Conformity of design specification, verification, and validation procedures with the updated standard!
Why have my Clinical Data been criticized as not sufficient?
Updated clinical data need to be included in the Product Risk Management and PMS Processes! Documented processes and plans to gather information and data need to fulfill specific MDR requirements to make them transparent to third parties. In case of missing clinical evidence, the manufacturer needs to carry out clinical investigations!
How can Innovations during the MDD-MDR transition still be realized?
Innovations are possible! An Advanced Feasibility Study with integrated Project Risk Management helps you to plan for the most critical product and project risk! This process allows you to analyze the technical and user-relevant risks of your innovation as well as your business and organizational risks. On this basis, you can reliably derive the costs, time, and effort to adjust your decision for further project realization at any time!