The EU Medical Devices Regulation (MDR) requires all manufacturers in the EU to classify their medical and medical technology devices in risk classes and to have their risk and quality management systems audited. In this article you will find what companies now need to do about it.
The MDR covers practically all relevant aspects for the licensing and production of medical and medical technology devices.
The most important thing here is that all manufacturers need to establish a risk and quality management system and to have it audited. The MDR assigns all devices to risk classes. For example, pacemakers and artificial knee joints are assigned to class III, the most critical. Depending on the risk classes of their products, manufacturers must define specific production, quality assurance, and recall processes. It means that all products must be traceable, the tools, machines, and processes used for the production of these devices and the results achieved must all be documented.
Among other requirements, the regulation states that each individual device must be unambiguously identified, for example by a barcode.
The Medical Devices Regulation (MDR) supersedes Directives 93/42/EEC and 90/385/EC, and this new law adopted by the European Parliament must be followed by medical devices manufacturers. The audits will be carried out by the “notified bodies”, the inspection agencies that review and assess the technical documentation for medical technology and have the legal power to shut down a company if the relevant requirements are not attended. The period to submit the audit required by the regulation is three years, up to May 2020. If we assume that the notified bodies can carry out the audits in about one year, thus the manufacturers will have only about two years to implement the MDR.
Be prepared! This is an extremely tight time schedule.