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Critical Questions About the European MDR Answered


For an intelligent understanding, the European Medical Device Regulation (MDR) is an updated batch of regulations employed to oversee the manufacturing and dispersal of medical devices across Europe. It’s essential to mention that all medical device companies must maintain compliance with these regulations to retail their medical products in the said continental marketplace.

Here’s a detailed breakdown of the most critical questions about the new MDR that can serve as a reference point for medical device companies.

Reasons Behind the Updating Of MDD?

One can chalk out several reasons for the reforming of the Medical Devices Directive (MDD). When the MDD came into effect back in the ’90s, there was no existence of software as a medical device (SaMD).

There’s no denying that the overall European demographic has evolved since the ’90s. With the more extensive population aging in time, the demand for transparency in medical devices and any data related to its technical information is higher than ever.

When you learn EU MDR, you realize that such factors contribute significantly to the reformation of MDD with a new directive. It aims at accelerating more comprehensive compliance with standardized MDR throughout Europe.

List of Devices that the MDR Covers?

As per the European Medical Device Regulation, the term “medical device” can be explained as an instrument, appliance, apparatus, implant, software, reagent, or material. Here’s a detailed breakdown of the scenarios where the device can be used.

  • First of all, medical evaluation, observation, treatment, or improvement of disease. However, the likes of disability or injury prevention should not be taken into account.
  • Secondly, there is a medical examination, modification, or replacement of any structural, biological, or neurotic process
  • Thirdly, supplying information by way of in-vitro examination of human body samples.

Although the definition clouds an extensive list of medical devices, it goes much beyond. The newly formed regulations determine a particular product type for CE marking availing.

What are the Essential Thematic Changes in the MDR?

For an astute understanding, the EU MDR puts lesser emphasis on the pre-approval phase of device development instead of encouraging a lifecycle approach to device regulation. This is drastically different from the original or the predecessor of MDR, i.e., the MDD.

The now-outdated MDD played a crucial role in medical device companies attaining their CE marking. However, when you learn EU MDR, you come across the latest regulatory set that promotes protocols and practices that raise the duties of medical device companies for their products.


A simple google search will identify that the European market includes twenty-seven member states, without the UK. Additionally, other nations such as Norway, Liechtenstein, and Iceland fall into the European Economic Area. This mass landscape inhabits a fast-aging population (500 million people on average).

This rapid aging population directly contributes to the more significant risks associated with adverse medical events and device malfunctions.

The EU MDR essentially teases at how the medical device regulation will evolve in the upcoming decade. Even though the operational date for the MDR is still a distant possibility as of now, developing healthy compliance with the regulations from today will bring long-term success and prosperity to any medical company invaluable markets across the continent.