EU MDR Compliance: the Effect of the Updated EU MDR 2021 Regulations on Connected Medical Devices

Medical device regulatory requirements in Europe are undergoing some major changes. As of May 26, 2021, the EU’s Medical Devices Regulation (or MDR) is in full effect. This legislative shift will ensure the public is protected by rigorous medical device safety standards. It also introduces a slew of new responsibilities for device manufacturers and healthcare providers. 

The extensive reporting requirements for EU MDR compliance strongly incentivize the adoption of connected medical devices. Using the data these devices collect to perform regular post-market research provides more timely and detailed information and eliminates much of the manual work required for compliance with MDR legislation. 

What EU MDR Compliance Looks Like 

The MDR is a replacement for the MDD (or Medical Devices Directive). MDD previously provided guidance regarding classification and safety standards of medical devices in the EU market. It will also replace some of the Active Implantable Medical Device (AIMD) directive annexes.

While the MDD and AIMD Directive’s rulesets were considered recommendations, the MDR’s standards are legal requirements. Although the UK is no longer a part of the EU it chose to adopt the change in regulations with their own version of the MDR including many of the same stipulations.

Here is a brief overview of some of the new MDR guidelines

  • Both manufacturers and healthcare providers are required to maintain an up-to-date inventory of all medical devices that are currently in use.  
  • Manufacturers and healthcare providers must collect and synthesize more clinical data to support any performance or safety claims they make regarding their products.
  • Manufacturers are required to implement UDI (unique device identification) for all medical device products, which must appear on the labeling for those products. 
  • Manufacturers are required to significantly extend their Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PCMF) efforts to ensure ongoing public safety. 
  • Manufacturers must update technical documentation and labeling to conform to new EU MDR requirements. 
  • Manufacturers selling existing medical devices must re-certify those products (though certain Class I products can still be sold without re-certification until May 26, 2024, if they meet MDD requirements). There is currently no plan to grandfather any existing products that do not meet MDR standards by the appropriate date. 

EU MDR Goals and Rationale 

The purpose of introducing the EU MDR is to improve medical device standardization and consumer safety. Some of its goals include:

  • Confirming the device works as intended and in accordance with the information presented on its labels and packaging
  • Discovering any previously unknown side effects of device use
  • Identifying any risks associated with using the device
  • Identifying common ways that people might misuse the device and what risks are associated with this behavior

Even though the MDD was already in place and performed many of these functions, updated regulations were needed specifically to reflect the changing definition of the term “medical device.”

Technologies such as smart electronics did not exist in 1994 when the MDD was first introduced. They have since become commonplace. If these devices are to be used in a health-related capacity, they must be held to the same high standards as blood pressure cuffs, glucose monitors, and other more conventional medical devices.

Implications for Connected Medical Devices 

As the MDR begins to exert influence over the medical devices market, it is likely that connected medical devices will become increasingly common in both clinical and research settings.

Each device’s regular transmissions to the cloud can be used to determine if it is actively in use at any given time. This allows organizations to easily fulfill the inventory management obligations laid out in the MDR and eliminates the possibility of human error during the recording process.  

The ability to automatically collect and transmit health data makes EU MDR reporting and PMS obligations much less burdensome. The data obtained using the device’s standard capabilities can create CERs (clinical evaluation reports) required both before and after a product launch. Any incidences of malfunction, injury, or death can be recorded immediately with extensive supporting data to provide context for further investigation. 

Connected medical devices can also be tested more thoroughly during all stages of the design process. Because data capture is part of their basic functions, the documentation process associated with these tests can be swift and in great detail. Design flaws, hazards, and other critical oversights can be identified in the early stages of product development rather than later, when they may be considerably harder to remedy. This not only assists with EU MDR compliance but also helps companies get products to market faster and with lower development costs without compromising safety standards.

Embrace the EU MDR for Medical Devices With BioT 

Connected IoMT devices are the answer to many of the challenges posed by the new EU MDR regulations. But in order to use them to their fullest potential, organizations will need specialized medical device platforms to manage the data these technologies are constantly generating. 

BioT’s connected medical device platform offers all the functionality you need to make the most of this incredible technology. Our software allows users to store, monitor, and analyze massive amounts of health information on a real-time basis, issuing alerts when the data it receives falls outside of expected parameters.

Several optional modules allow you to collect additional information for PMCF reporting using patient questionnaires and electronic case report form integration. Our platform is fully secure, meets all HIPAA requirements, and is compatible with all wireless health devices from wearable fitness trackers to implantable pacemakers.  

If you are interested in bringing connected medical devices to your hospital, office, or research facility, contact us today and let us help you make it happen. 

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