MDR (EU) 2017/745
We have been busy compiling successful submissions of Class III, IIb and Ir technical files with approval under MDR of ISO 13485 QMS and the design and manufacture of custom implants. MDR needn’t be a minefield when you use it and apply it successfully – though there is a lot to do and understand. Here are a few tips which we have found useful:-
- Good planning for legacy products is required mapping out the required testing and any gaps in compliance can save significant time and cost.
- Provide the information in a concise way – follow the guidelines on compilation.
- Submit only relevant information – old test reports which are not to the latest standards adds to review times and more questions.
- Packaging and labelling – review these carefully and ensure that they have the correct information and match the IFU, GSPR.
- Risk management is updated with complaints detail and that mitigations are specific referring to verification/validation etc.
Good luck.