What will change for medical device manufacturers
It is feared that the stricter controls will lead to delays. In the worst case scenario, the delays could affect patients who are in dire need of the devices.
In the long term, the measures of the Medical Device Regulation, together with all subsequent adjustments, should achieve better quality and safety for consumers.
Certification for the entire market
There is no grandfathering provision for medical devices, which is why every device placed on the market must be updated to meet the heightened requirements.
More stringent requirements for notified agencies
The legislature has also made the requirements for notified agencies more stringent. This has made it more difficult for the testing authorities to gain recognition as such and to offer tests for every medical device.
Extended and stricter definition for medical devices
The revised definitions for medical devices, which propose a wider understanding of the term than was used before, should also not be underestimated. Some commonly used products are now regarded as medical devices and have to pass the same strict processes.
A refrigerator, for example, is now considered to be a medical device if it is used to store medical substances. And software in the field of medical technology must also be treated as a medical device depending on its intended use.
Products that are used for the (sterile) cleaning of medical devices also now fall under the definition.
Unique device identification (UDI) for each model
The introduction of unique device identification (UDI) for all medical devices means that ones that are currently in circulation to be traced back to their manufacturer. This innovation was directly adopted in response a triggering incident for the new legal regulations: a Parisian silicone implant that burst in the wearer's chest could not be traced back to a responsible manufacturer because there was no origin information about the device in the hospital records.
New classification with stricter risk levels
The Medical Device Regulation provides for a different classification. There are now more classes as well as other assignments. Overall, the risk ratings have become stricter. In order to continuously monitor safety, the EU also requires manufacturers to introduce a risk management system that is embedded in a quality management system.
New quality management system
The device numbers require that every company adopt a new quality management system. Thanks to this quality management system, manufacturers can respond properly to random test procedures, which request device-specific evidence, among other things. Each manufactured medical device must remain registered in the EUDAMED database for 10 years after being placed on the market, and implants must remain so registered for 15 years.
A responsible manager at every company
In the future, a responsible manager who must be employed by the company will be responsible for ensuring compliance with the regulatory and organizational guideline requirements of the MDR.
Clinical trials: Analyses are only provided on request
Stricter criteria now also apply to the evaluation of clinical analyses and trials, which is why manufacturers have to take a much more differentiated approach to the selection of equivalence analyses. Because comparative studies of similar devices are no longer sufficient, the MDR stipulates that they must prepare or commission their own studies more often than before.
In addition, test centers can carry out unannounced audits at medical technology companies and their suppliers at any time. That is why it is important to work with certified suppliers. Suppliers that can be checked without needing to receive notice also include language service providers, such as medical translation agencies.
Manufacturers must also prepare annual reports based on quality management.