A „Person Responsible for Regulatory Compliance“ (PRRC) according to MDR has the task of ensuring that the company and its medical devices comply with the requirements of the MDR.
Their task is to ensure that:
- The Technical Documentation is created and maintained to demonstrate the conformity of the device with the requirements of the MDR.
- Risk assessments are conducted and documented to ensure that the device is safe and effective.
- Conformity assessments and certifications are carried out to ensure that the device complies with the requirements of the MDR before it is placed on the market.
- The Surveillance of the product is ensured throughout the product life cycle and measures are taken to address any issues that may arise during use of the product.
- Processes and procedures are established and implemented to ensure compliance with the MDR requirements.
- Training is provided to company personnel to ensure that the requirements of the MDR are understood and complied with
- Communication with the competent authorities is effective and the duty to cooperate is fulfilled.
This task requires appropriate training and experience and should not be underestimated. The authorities check formal suitability on the basis of CVs, certificates or attestations. In addition, you must be prepared to make unpleasant decisions that may determine whether the medical device remains on the market. At the same time, it is important to take an analytical approach to the task and not fall into panic-stricken actionism.
With our more than 20 years of experience and corresponding experts, BEO BERLIN will be happy to advise and help you. If necessary, we can also take on this task for you on a temporary basis. We look forward to supporting you. Contact us!
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