It is easy to become overwhelmed while trying to piece together an MDR strategy so it’s really important to consider one central fact — working with the MDR is, in a large part, about knowing how to work with clinical evidence. Whether it’s generating, searching, reviewing, appraising, interpreting or reporting clinical data, medical evidence is at the heart of MDR compliance.
However, in the absence of a medical or scientific background, working with clinical evidence isn’t easy. With the increased complexities of the new EU MDR, medical device manufacturers need easy access to skilled professionals who are comfortable working with and generating clinical evidence.
Medical doctors are increasingly recognised as being perfectly positioned to meet this requirement. Doctors are trained to work with clinical evidence from the early stages of their career. Furthermore, in many cases they have worked as clinical investigators on medical studies, meaning that they are better qualified to drive compliance with clinical investigation data entry.
Medical doctors also have a thorough understanding of the conditions that medical devices address, and have general clinical training that enables them to put diseases and interventions into context. In turn, this means that doctors are able to advise on pertinent data-points that can extract maximum value from Post-Market Clinical Follow-up (PMCF) and other performance monitoring studies.
Another advantage of working with medical doctors for MDR compliance is that doctors are professionally trained to perform objective assessments of clinical information, resisting sources of bias. This professional objectivity is of huge value in meeting MDR requirements for performing Clinical Evaluation of medical devices. Engaging a suitably-trained medical doctor from outside your organisation demonstrates a commitment to regulatory objectivity that will be favourably viewed by Notified Bodies and other regulators.
Doctors are also of value when trying to assess any gaps in a medical device’s clinical evidence portfolio. An expertly-performed literature search & review helps ensure that no relevant data is overlooked, and can also help to minimise expenditure on clinical investigations to generate new clinical data.
In summary, doctors have much to offer in helping medical device companies meet MDR requirements. Whether you are looking to design PMCF studies or perform Clinical Evaluation, engaging a medical doctor can be hugely advantageous.
So how can you find medical doctors who are trained in MDR compliance? At Mantra Systems we have a dedicated team of expertly-trained doctors who are specialists in producing and maintaining MDR strategies. Please see our Medical Device Regulatory Consulting Services or contact us to see how best we can work together.