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Are You Ready For Article 88 Of The MDR?
Medical device manufacturers should use the time leading up to the MDR
Statistics – a mommoth task
For most manufacturers, this will be extremely difficult to realize within the next two years. Especially since each manufacturer has to choose the proper statistical model as the basis for their market observations. Furthermore, they will also have to investigate which model they had been using for their benefit-risk analyses to date – meaning they will have to closely examine the extent to which their clinical evaluations are based on consistent and verifiable statistics.
That in and of itself can prove to be a mammoth task, since clinical evaluations were generally created based on scientific literature, which in turn, was usually checked for quality. Meaning what was examined was the validity of the literature and the author’s qualifications, the verifiability of the patient population and equivalence of the medical device. Statistical questions played a much smaller role and were frequently based on in-house data from complaint management.
Identify and eliminate compliance risks
Add to that the fact that many manufacturers established a practice of relativizing reported complaints by considering them in relation to units sold – although there was rarely a proactive attempt to estimate the number of unreported complaints. Furthermore, many companies did not effectively collect information on “expected undesirable side effects”, such as on the effects of product application, e.g., skin burns where electrodes were placed on a patient during defibrillation.
Exactly these and other details of information collection and data verification should be on a company’s compliance agenda within the context of the MDR. Article 88-compliant will be manufacturers who
Have a multidisciplinary team actively address these tasks
Define a statistical model
Have proactive complaint management
Set up interfaces to risk management, product development and sales with their customer or user contacts
Combine all of these aspects with the post market surveillance plan that will be required under Article 84 of the MDR in mind
Is your company perfectly prepared to tackle these and other challenges of the MDR? We would be happy to assist you with further technical information and with the implementation arising from the new statutory requirements of the regulation.
Lead Business Consultant Medical Device
Martin Rümke | Lead Business Consultant Medical Device
Martin Rümke is a Lead Business Consultant Medical Device at msg industry advisors ag. He specializes in consulting in the fields of medical devices, compliance and quality management.
msg industry advisors ag
+49 89 96 10 11 300
+49 89 96 10 11 040
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msg is an independent international group of companies with autonomous regional companies and subsidiaries and over 9,000 employees.
The msg group is active in over 25 countries in the banking, insurance, automotive, food, life science & healthcare, public sector, telecommunications, travel & logistics and utilities sectors. msg also develops integrated software solutions and advises its clients in all aspects of information technology.
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