(12/2020) by Jan Badorrek and Julia Pernice, Consultants Significon AG / Mainz
After various scandals in recent years with defective medical devices, a revision of the Medical Device Directive (MDD) should ensure better safety of medical devices and their monitoring. With the new Medical Device Regulation (MDR), companies will be faced with a large number of changes. The authors list important innovations and give recommendations for action.
The postponement of the implementation of the EU Medical Device Regulation (MDR) by one year to May 26, 2021 now gives companies an additional year to implement, which needs to be put to good use. In the following, the most important key points with regard to quality management and software are summarized and a small recommendation for action is provided on how the additional year can be optimally used.
Quality management
Depending on the risk class, manufacturers of medical devices were already obliged to monitor and secure their processes using certified quality management and to validate their application systems and processes. Even if the higher classification of products will already have an impact on the extent of the regulations to be complied with, the challenge will be felt in particular for those companies that previously did not fall under the regulations of medical devices and for which the compliance to the GxP- Regulations mean completely new territory. This is because regulations expressly apply to certain devices without a medical purpose but with similar properties. This applies, for example, to fillers and colored contact lenses for cosmetic purposes and confronts manufacturers who previously only required a CE mark with a whole new range of requirements. In order to make the entire path of the medical device to the patient traceable, the distributors (dealers, importers or authorized agents) are now also subject to these requirements for the first time. Until now, in the medical products sector - unlike in the pharmaceutical industry - the motto was often: "Courage to fill the gap". There will also be little scope for this in the future, because for the first time the notified bodies and inspectors themselves have come under increasing scrutiny. They are expressly encouraged to conduct unannounced audits; Whether and which measures have been initiated must also be documented and subject to review. This should lead to a significant increase in controls.
Technical documentation and tools
The scope of the technical documentation to be created for the medical device will increase. In addition to the clear identification of the product, it must be described in its variants including configuration and accessories. A precise purpose must be given as well as the precise description of the "labeling" and information on the design and manufacture of the product. The so-called risk management files as well as the verification and validation of the product are also required. The latter serves to prove that the basic safety and performance requirements are met. The verification and validation of the medical device is achieved through the triad test description, test result and clinical evaluation. All aspects of the medical device - physical and electronic - are verified and validated. The traceability of the medical device path to the patient, which is required above, and the increased demands on quality management are reflected in the manufacturer's obligation to carry out post-market surveillance (PMS). Since large amounts of data have to be collected, prepared and processed in order to create the PMS plan and reports, the use of software tools is almost a necessity. In general, it should be noted that every application system and tool that is to be used in the GxP-relevant area must be validated according to ISO 13485: 2016.
So what is to be done?
Medical device manufacturers should now make sure to invest the time "gained" by Corona in checking their own processes, risk assessment, completing documentation and completing the market tracking and vigilance system. In a five-point plan, we have put together an example of what a structured approach can look like:
1. Awareness training
As an experienced consultancy for pharmaceuticals, medical products as well as "hybrid companies" (in the classic sense chemicals or manufacturing companies with only a small product range in the GxP-relevant area), we recommend for the
