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How The EU MDR Changed The Landscape of Process Validation

Spoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation.


EU MDR and Process Validation

How the EU MDR Affected Process Validation


The Medical Device Regulation (MDR) has been a focal point of conversation and analysis in the whirlwind of regulatory updates and compliance shifts.


Let's admit it: there is a fair share of anxiety within the medical device industry.


With its implementation, professionals across the sector have been dissecting the new requirements, deciphering the implications for product development, and recalibrating their compliance strategies to align with this monumental regulatory overhaul.


Amid this frenzy, a stark reality persists – process validation, a concept as old as some of us in the field, remains misunderstood and under-implemented.


The Evergreen Challenge of Process Validation


The requirement for process validation was first introduced in 1987, making it as seasoned as some veterans in the industry.


Process Validation ensures that production processes consistently produce outcomes that meet predetermined quality criteria.


It's a foundational element of quality assurance, yet, astonishingly, it's often overlooked or inadequately addressed even three decades later.



Elements of Process Validation
Figure 1 Elements of Process Validation [1]


EU MDR's Emphasis on Process Validation and the Reality Gap


While the EU MDR 2017/745 has undeniably heightened focus on several areas of medical device development, it did not introduce the requirement for process validation nor test method validation (TMV); instead, it underscored its significance.


The new regulatory landscape demands rigorous compliance, yet the implementation of process validation practices – essential for ensuring device safety and efficacy – lags behind.


This disconnect between regulatory expectations and industry practices highlights an important gap: while Process Validation has been demanded for years, it has apparently not been treated with the attention it deserves.


Process Validation: The Misconception About EU MDR


The misconception lies in the belief that the advent of EU MDR brought about the need for stringent process validation.


In reality, process validation has been a fundamental prerequisite for ensuring quality and safety in the manufacture of medical devices for decades.


The ongoing challenges and lapses in implementing these age-old requirements suggest a deeper issue – a systemic oversight in seeing the value and necessity of process validation.


Bridging the Gap: What Changes The EU MDR Brings To The Topic Of Process Validation


The EU MDR did not invent the requirements for process validation, but obviously made it clear that it was needed (apparently it was not sufficiently emphasized before).


Addressing this oversight requires a concerted effort to elevate the understanding and execution of process validation within the medical device industry.


It's not merely about compliance; it's about embracing process validation as a cornerstone of product quality and patient safety.


The key lies in education, sharing best practices, and fostering a culture that prioritizes thorough validation as a part of the development and manufacturing ethos rather than viewing it as a regulatory checkbox.


Process Validation & The EU MDR: The Call to Action


The journey towards full compliance with process validation requirements is both a challenge and an opportunity.


It's a chance to redefine quality standards, enhance safety, and ultimately, build trust with patients and healthcare providers.


I invite you to delve deeper into the intricacies of process validation and other pivotal topics within the medical device industry.


Explore insights, experiences, and strategies on our MedTech Blog (especially Medical Device Process Validation) and subscribe to our YouTube channel.


Let's navigate the complexities of regulatory compliance together, share knowledge, and elevate our industry standards to new heights.



Simon Föger







Author: Simon Föger | CEO SIFo Medical


PS: If you have any specific questions about process validation, send us a message to office@sifo-medical.com. We will gladly support you on your journey to compliance and efficient processes.


References:


[1] M. Schaefer and TÜV SÜD AG,  “Process validation in medical devices”, 15.09.2017. [Online]. Available: http://www.quality-on-site.com/get.php?fileid=139

(accessed March 11, 2024)


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