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Oh, MDR! Look, what have you done? Part 2



In the previous blog, our team members considered MDR as a Time-Consuming Paper Monster. Are we too harsh, or are the Medical Device Regulations too harsh for manufacturers and stopping the innovation process?


Well, we have ‘decoded’ the new requirements and we can say that MDR is an Opportunity for Innovation!


MDR Boosting Confidence through Clinical Data:


Emphasising general safety and protection, MDR has created a need for managing clinical evaluations and collecting your own data.

The MDR, including the associated guidance documents, compels manufacturers to conduct a clinical evaluation of their medical devices, regardless of their risk class. This requirement has urged manufacturers to systematically collect, collate, analyse, and evaluate clinical data on a product.


Through this, manufacturers will be able to verify and demonstrate their product’s safety, performance, and clinical benefit. Continuing the requirements, clinical trials will be inevitable for certain risk classes and product groups in the future.


Why do you need Clinical Evaluations?

In our Expert’s opinion, a clinical evaluation aims to present detailed evidence of the safety and performance of the product. It gives an overall picture of current technical know-how. When done regularly, a manufacturer has up-to-date information about their product.


This will undoubtedly increase manufacturers’ efforts, time, and cost, but; these trials help manufacturers establish a base for any future innovation. A clinical trial for a Novel Product might establish that this product already exists. Additionally, because of the increase in cost, clinical trials will boost innovation. Why?  This is because clinical trials will raise the question – Is it worthwhile to wait for a competitor to place an innovative product on the market using its own studies and then “piggyback” onto the competitor’s product with a favourable equivalence assessment? Avoiding the literature review, manufacturers will be well off if they know their products and invest time and money in collecting data for these trials.


As an end-user of the innovation, there will be a sense of relief as the customers/patients will be confident because the product demonstrates general conformity and safety. Finally, each manufacturer demonstrates, through performance and clinical data, that their product is safe and performs well; the risks of use must be proportionate to the expected benefits.

These safety and performance requirements did exist under MDD, but the requirements for evidence have been specified in the MDR. The assessment of whether it is an equivalence product is much more profound, as the transferability of the existing clinical data needs to be justified in a much more informed way and supported by further data. The IVDR also describes performance evaluation as an ongoing process to demonstrate the clinical performance of devices.


Let’s talk about Post-Market Obligations


The EU MDR regulations have significantly reinforced post-market surveillance of devices. Section I/Chapter VII of the MDR (in the IVDR also Chapter VII, Article 78 ff and Annex XIII) require manufacturers to plan, establish, apply, maintain continuously, and document updated compliance in the post-market surveillance systems. This system is a part of the Quality Management practices and needs to be designed appropriately based on risk class and type of device. This requirement covers the entire life-cycle of the medical devices, collecting and analysing data on performance, quality, and safety. This allows for continuous improvement, preventive measures, and corrective actions.


Since PMF and QM systems are extended through the product life-cycle, manufacturers can systematically collect and analyse relevant data related to the performance and safety of the product. It enables manufacturers to draw necessary conclusions, understand the product better, and help them monitor/implement preventive measures if necessary.


Because of this continuous process, manufacturers can upgrade or reshape the device. Through a strict Post-Market Surveillance system, there is scope for reviewing the product regularly and enhancing or applying any preventive measures. The end-user/patient will also feel comfortable using the device because the manufacturers maintain regular checks and product reviews. Through MDR/IVDR, there is a new horizon of innovation through continuous improvement and further exploration into patient safety and product performance.


Let’s explore further! Our Experts have made considerable efforts in linking this up!


MDR and Risk Management:


Risk Management is a central component of medical devices. MDR has showcased the risk management process as a Positive risk-benefit assessment vital for the conformity assessment procedure. MDR Annex I, section 3 states: “Risk management is to be understood as a continuous iterative process throughout the life cycle of a product, which requires regular, systematic updating.” Until now, many manufacturers ignored this activity, but with the incoming of the MDR, Risk Management has increased workload.

Don’t see this addition as a barrier but see it as an opportunity!


How is this an Opportunity?


When implemented from the start, Risk Management can help identify risk and create plans to reduce any potential risks that may arise in the product development phase. Since you have established an efficient risk management process at the start, it will be easier for you to comply with the Post-Market Surveillance requirements. A well maintained and statistically structured risk management file will serve as the foundations for a dynamic risk management system provided it is followed diligently by the manufacturers. Indeed, the additional documentation required to meet the increased requirements of the MDR depends individually on how the existing system looks and has been maintained and may pose a significant challenge for the individual manufacturer. But once this work has been done, the manufacturer can derive the added value and enhance safety for the patient. And depending on the target markets, this could mean a benefit not only for European patients but also for target countries outside Europe (not yet considered by the manufacturer).

We are sure you are convinced by now, but we have one more point to discuss.


Medical Device Safety and Efficacy:


The Essential Requirements (MDD) have become General Safety and Performance Requirements (GSPR). This ‘upgrade’ has widened the scope and brought in many more requirements. Referring to MDD, the principle of continuous conformity assessment existed but was often not understood as a continuous process but as a final element of product development. Due to the increased documentation obligations in the area of  General Safety and Performance Requirements, the manufacturer is constantly confronted with whether his product corresponds to the current ‘state of the art’ on the revision date and can be placed on the market by him with a clear conscience. This again links us to the enhanced scope of improvement, innovation, and increased patient confidence in the product. MDR is up-to-date evidence of the safety and efficacy of medical devices.



The obligations of manufacturers go far beyond placing the device on the market, but at the same time, the tools of the MDR allow:

MDR brings benefits for all players of the ecosystem. Manufacturers and Users get a better idea of the product and increase their confidence in patient safety and product performance. The regulators can keep a close eye on any incidences, and ensure corrective measures are taken to protect the people’s health. Overall, the industry generates new employment, new business methods, and a strong foundation for global trade practices. When implemented and followed in its total capacity, MDR has the potential to set a global benchmark in the Medical Device industry. New implementations offer companies an opportunity to put processes to the test and discover possibilities for optimisation.


The new requirements and guidance from the standards and the GSPRs of the MDR help with the continuous improvement of existing products. Meticulous PMS activities can efficiently identify when unknown risks emerge, or ‘state of the art’ is no longer achieved.

We all know the state of legalities, and we all aim at enhancing the patient care process. Med-Di-Dia strongly appeals that Innovators and Manufacturers should not ignore the regulatory aspects of the device. Don’t let regulation become a barrier to your innovation.


You have full access to our Passionate experts who have 20+ years of experience in the medical industry. They can help you create a smooth pathway for the success of your Medical Device/Innovation!


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