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MDR: the end of an innovation Era, or an opportunity to demonstrate Value?


Imagine you’ve been working for years on a medical technology of your design. You have applied for a CE mark. But now, everything has changed. The European Union’s Regulators have issued new guidelines stating that upcoming products may not be available on the market if they do not meet specific requirements. These guidelines also apply to your current portfolio: Your old, safe and reliable pacemaker must be re-tested repeatedly at high costs and with uncertain prospects.

While the old Medical Device Regulation (MDD) was an essential manual for how medical device companies could get their CE marking and market their products, the new European Union Medical Device Regulation 2017/745 (MDR), applicable since 26 May 2021, elevated the responsibilities of these companies throughout the entire product lifecycle.

Impact to new but also existing products

The MDR applies to your new products and those you already have on the market, also it may impact the decision-making processes of innovators and investors. They will likely consider the commercial Value of their innovation more carefully than before. They will probably be more conservative regarding their product’s potential market access and uptake, especially in markets where many competitors are already active.

In addition, some innovative companies or investors may focus on other regions where requirements are lower.

Medical device regulations have changed recently, making it more expensive and time-consuming to bring new products to market. Manufacturers must collect and document more data, provide evidence and conduct clinical studies, depending on the risk class and degree of innovation.

Medical Software will need Clinical Evidence

The MDR also considers essential aspects before medical technology companies introduce their digital solutions in the market.

As opposed to the old MDD, there is now a framework for the determination of the appropriate level of clinical evidence required for Medical Device Software (MDSW) to comply with the requirements set out in the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The new regulations do not apply to any software in healthcare. As a general rule, if your digital solution can impact the patient’s journey, then it would be best to review the MDR and consider how you will generate the appropriate level of evidence.

Many digital health companies will now need a solid clinical evaluation plan and consider how it can support their value messages.


Doctor looking into tablet for medical data
Doctor looking into tablet for medical data


An ongoing focus on Clinical Evidence

The clinical evaluation process under the new MDR is a critical component of ensuring that the use of a product comes from a sound evidence base. Clinical evaluation involves the assessment and analysis of clinical data about a medical device to verify the clinical safety and performance of the device

Clinical trials may have to be conducted and the performance and safety reports need to be updated regularly and their results made publicly available. In the case of implantable devices and Class III products, Clinical Evaluation Reports may have to be updated annually.

Different companies have been expressing concerns about Europe continuing to be the first place for launching medical innovations.

Maintaining an old clinical data repository is no longer sufficient to support your products. Companies will need to consider an ongoing process of proving clinical outcomes and safety.

The need for Value Dossiers

The new MDR is now a reality and represents the most critical change to the medical devices sector in decades, impacting both the marketing of medical devices and their development, subject to greater transparency.

The aim is to improve patient safety by providing better information about the benefits and risks of medical technologies. Medical companies will need to provide more information about their products, including clinical evidence demonstrating their effectiveness and safety.

Clinical Evaluation Reports bring a systematic collection of documents presenting evidence that a medical device demonstrates its Performance and Safety against intended use and labeling instructions. However, how to take such information and use it to substantiate the Value of a medical technology?

Value Dossiers demonstrate the Value of a medical device with its therapeutic efficacy, safety, quality, innovation, and cost-effectiveness relative to competing products or treatments. Hence, they serve as a framework for organizing the Clinical Evaluation Reports data as well as other MDR aspects.

Although not required under the MDR, in practice Value Dossiers will be instrumental in helping medical technology companies achieve the MDR’s original objectives while providing a single source document to guide market access and commercial teams in demonstrating Value.

Takeaway: Want to prepare for the MDR? Start working on your Value Dossier now

It is typical for companies to be concerned and see the MDR as a barrier to innovation. And there is a logic to that since costs and timelines to bring a medical technology onto the market will be higher. And that will also apply to products on the market.

On the other hand, companies that invest the time and resources to prepare living documents such as Clinical Evaluation Reports and Post Market Surveillance can use these fundaments to create Value Dossiers. This way you will always be ready to address questions from regulators, payers, and providers.

For those companies, the MDR will create a substantial competitive advantage over the traditional competitors by focusing on features, benefits and price.

Welcome to the new era of value-based innovation. Welcome, MDR.

Want to know more about how a Value Dossier can help you?

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