Modern medical products are an undoubtable miracle, but they didn’t achieve the safety or effectiveness we see today without some stringent and strategic frameworks in place. Continuing in that tradition is the European Union Medical Device Regulation (EU MDR) framework, which is among the world’s most prominent and impactful medical device regulations.
What Is EU MDR?
The EU MDR is a framework of regulations that govern the production and distribution of medical devices in the EU. It was first published in May of 2017 by the European Commission in an effort to heighten the Union’s standards when it comes to the quality and safety of medical products used in its member states.
EU MDR requirements apply to any manufacturer, importer, authorized representative, or distributor of medical devices in the EU. Those that fail to meet EU MDR compliance guidelines or standards face a slew of consequences and repercussions, including costly fines, product recalls, mandated design changes, or lack of access to the European Union’s market altogether.
A Background On EU Medical Device Regulation – MDD To MDR
While EU MDR 2017/745 has made quite a name for itself in the world of medical device regulation, it isn’t the first framework of its kind to come out of the European Union. These guidelines follow a number of other notable regulations which also sought to address the same issue.
The most notable of the EU MDR’s predecessors is the MDD, or Medical Devices Directive, which was established in 1994. It was similar to today’s guidelines in nature–applying to devices sold within the European market–but differed in that it did not cover products without an intended medical purposes but which are analogous to devices with a medical purpose (e.g. non-corrective contact lenses).
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Comparing MDR vs MDD
While the MDD was an important EU medical device regulation for its time, it eventually began to lack in certain aspects as markets and technologies both evolved. This gave way to the creation of the MDR in 2017, which introduced a number of new requirements like use of Unique Device Identification (UDI).
EU MDR 2017/745, accompanied by the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, updates decades-old EU regulations to be more in line with current industry conditions and likewise creates a more transparent and effective regulatory framework for ensuring patient safety.
How It Works: EU Medical Device Classification
In order to get a better idea of how the European MDR works, it’s important to first understand how medical devices are classified under its technical documentation.
There are four main classes of medical devices that are outlined in EU MDR guidance: Class I, IIa, IIb, and III.
Class I medical devices are the least risky and are therefore subject to the fewest regulatory controls. They include simple devices like bandages, tongue depressors, and syringes.
Class IIa devices present a moderate risk to patients. Products like cut and coag generators and pregnancy tests can be considered class IIa.
Class IIb devices present a higher risk to patients. These include devices like manual defibrillators and screws or plates used in orthopedic surgery.
Class III devices pose the highest risk to patients. They include items like breast implants, heart valves, and brain implants.
Credit: Ksenia Chernaya
EU MDR vs Other Countries’ Medical Device Regulations
The EU MDR regulation isn’t alone in its efforts to improve patient safety and quality control within the medical device industry. In fact, it has a number of counterparts in other regions around the world.
The United States
One example is the United States’ FDA, which is responsible for the safety and efficacy of all medical devices sold within its borders. Under its premarket approval (PMA) system, medical device and product manufacturers must take a number of steps in order to obtain the pass they need to go to market.
This can include obtaining an investigational device exemption (IDE) to conduct clinical studies, submitting a premarket notification (510k), and undergoing thorough review for substantial equivalence prior to premarket notification clearance.
The US also has what’s called the Medical Device Reporting regulation, which is used to monitor products on the market for ongoing compliance.
Japan
Similarly, Japan has its own group for regulating medical devices, known as the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). To obtain approval to sell their products in Japan, medical device manufacturers must submit an application that includes a wide range of documentation on the product itself. The review process is conducted by a panel of experts who will make a decision on whether or not to approve the product for sale.
Meeting EU MDR Regulations
While EU MDR regulations and those around the world can differ slightly in their content, they all share one common goal: to protect patients. Thanks to their rigorous quality systems, the medical community is able to provide patients with the highest level of safety and quality control when it comes to medical devices.
RBC Medical has been working on EU MDR compliant devices. We will ensure that your device meets the highest quality standards. Let’s talk about your next project.
Featured Photo Credit: Anna Shvets
