What you need to think about with the implementation of the MDR/IVDR
- Familiarise yourself with the new requirements and be advised by the experts.
- Carry out a fit/gap analysis.
- Manufacturers should consider now whether rationalisation of their products or portfolio makes sense. The principle of grandfathering will not apply. The question therefore is: Does it still make sense to invest in so-called legacy products?
- Draw up a schedule showing when you have to satisfy the new provisions for your medical devices and when the notified body will be nominated again.
- Discuss your transition strategies with your notified body.
- Manufacturers will have to temporarily operate under both directives and regulations, which may lead to confusion.
- Manufacturers will require qualified notified bodies for the declaration of conformity in order to obtain the product certificates before the end of the transition period.
- Conformity evaluation procedures: Note not only the time plans of the notified body but also the consequences of the expert committees that will be appointed by the European Commission.
- Individually prepared implants must be tested by the notified body for the first time.
- Review your current quality management and risk management systems.
- Review the labelling and update the technical documentation of your medical devices.
- Post-market activities: Identify when which plans are required, when they have to be updated and when high-risk devices must be submitted to the notified bodies for additional testing.
- Note the changes to the MEDDEV directive for the clinical evaluation or clinical trial among others.
- More stringent requirements are also being placed on the corresponding reports (e.g. Summary of Safety/Clinical Evaluation/Performance Reports).
- Harmonise the monitoring, controlling and vigilance requirements between the safety officers in the German Medical Devices Act (MPG) and the responsible or authorised person for regulatory provisions in the new EU regulations. The person should have certain minimum qualifications.
orangeglobal supports you - from planning to post-market surveillance of your product.
Your contact person:
Dr. Philip Welbergen MBA
Head of Global Regulatory Affairs & Vigilance
Tel. +49 731 954 95 - 513