5 Questions Answered About the New EU MDR

by Guenther Martin, on October 10, 2019

The EU MDR and IMDR regulations are approaching implementation.
The EU MDR and IMDR regulations are approaching implementation.

The European Union is rapidly approaching the implementation date for a new set of regulations, the EU Medical Device Regulations, designed to standardize medical device approval, labeling and tracking. Complying with these rules is necessary to keep your organization active in the European medical devices industry.

The following are a few questions you may have about the EU MDR. With these queries answered, you can move confidently into the next stage of medical device production in the European market.

Why Has the European Commission Introduced the EU MDR?

The latest European medical device regulations are designed to boost quality, transparency, safety and efficacy of medical devices within the health care supply chain. Through the adoption of policies such as mandatory Unique Device Identification numbering, the EU legislative body hopes to ensure greater oversight of the medical device sector overall. Commissioner Elbieta Biekowska explained that the new regulations are designed to be proactive, preventing problems rather than reacting to a scandal or revelation about device quality.

Using the European Database of Medical Devices, consumers in the EU will be able to look up information on the devices used in their own treatment, allowing a new and greater level of transparency between manufacturer and patient. In addition to creating greater information visibility, the regulations are designed to bring extra categories of products under the regulatory umbrella, including cosmetic devices such as colored contact lenses.

What is the Difference Between Standard Medical Devices and In Vitro Medical Devices?

The latest regulation is actually two related pieces of legislation, with the MDR joined by an In Vitro Medical Device Regulation. The medical device regulation covers a wide variety of items, from monitoring equipment such as X-ray machines to implants including hip replacements and pacemakers. Simple, one-use items such as adhesive bandages are also medical devices. In vitro diagnostic devices are used to analyze samples from the body, and include blood tests for HIV, pregnancy tests, blood sugar monitors and more.

The new EU MDR and IVDR are similar, with the addition of a new risk classification system that targets IV devices. In general, testing and approval guidelines are tightening, especially when dealing with products such as implants which could pose a severe health risk to patients. Device manufacturers will be required to collect clinical data on their devices once those products are on the market, to ensure quality and safety remain acceptable over time.

A doctor carries a tray of medical devices.Medical devices of all kinds are affected by EU regulations.

When Are the EU MDR Rules Taking Effect?

The implementation deadline for the EU MDR is May 26, 2020. The months leading up to that date may include significant scrambling among governments and companies alike. According to MedTech Europe, regulatory bodies should speed up their implementation of the approval framework tied to the MDR, due to the fact that current devices will have to go back through regulation to stay on the market. With that process potentially taking three to nine months, the need for urgency is clear.

What Kinds of Information Goes on MDR Compliant Device Labels?

The MDR calls for the use of a globally harmonized set of informational symbols on device labels to ensure medical professionals can quickly know facts about a given item by looking at its label. Employing pictorial symbols alongside text is especially vital in the EU, as the union's countries employ 24 official languages. MedTech Europe laid out the suggested symbols for early adopters of medical device labels, alongside recommended symbols for use on the implant cards given to patients using medical devices.

The unique device identification system is also part of the new and compliant MDR labels. If your organization already produces medical devices for the U.S. market, you're likely familiar with the UDI process as implemented by the Food and Drug Administration. UDI numbers consist of two parts, one of which corresponds with the device type and is searchable in a centralized database and the other associated with the particular production batch or period.

What Kinds of Enterprise Labeling Systems Help Medical Device Manufacturers?

To get in line with the evolving EU MDR and IVRD rules ahead of the rapidly approaching regulatory compliance deadlines, it's important for companies to improve their internal processes such as label production. If you operate a medical device manufacturing organization within the European market or sell into the region, you can select a modernized Enterprise Labeling Solution with a centralized structure that will make it simpler to validate your labeling and create compliant and consistent labels. A comprehensive solution reduces the risk of data duplication across departments and locations and enables business users to easily manage labeling variability and required changes to meet compliance by using business logic to create and update label templates. 

When your organization uses a centralized labeling system that can extend to partners such as distributors, suppliers and third-party logistics providers, you won't have to worry about the cost and inconvenience of relabeling. Your compliant device labels will be in place throughout your organization. The EU MRD and IVRD compliance deadlines are coming soon, which means you shouldn't waste time. If your present medical device labeling strategy isn't up to standards, you can and should make an upgrade.

Topics:Medical DevicesHealthcareRegulatoryTrack & TraceabilityGS1UDI

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