By Melissa
Medical Journalist | Covering Global Healthcare Policies and Compliance Trends
Since the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) officially came into force in 2021, medical device manufacturers worldwide have been grappling with an unprecedented “compliance upgrade battle.” For manufacturers of operating room (OR) equipment in particular, the new regulation signifies not only a rise in technical standards but also a reshuffling of the “entry pass” to the EU market.
What is MDR and Why Does It Matter?
The CE mark has long been the essential certification for medical devices to be marketed in the European Union. Under the previous Medical Device Directive (MDD), many low- to medium-risk devices could be approved with relatively limited documentation. However, MDR has raised the bar across the board, tightening risk classification, expanding documentation requirements, and even mandating that “legacy products” already on the market be re-certified under the new rules.
For example, an electric surgical table that previously only needed basic safety documentation under the MDD must now be supported by a full set of clinical evaluations and risk analyses under MDR. The manufacturer must also demonstrate the device’s mechanical design can ensure patient stability during transfer—backed by data and real-world use scenarios.
Why Operating Room Equipment Is Under the Spotlight
Operating room devices include a wide range of products—from surgical lighting and ceiling pendants to tables, monitors, and anesthesia systems. These devices are often categorized as Class IIa or higher under MDR, which means they almost always require assessment by a Notified Body.
Challenge 1: Rebuilding Technical Documentation from the Ground Up
Manufacturers must now submit a complete technical file, including clinical data, risk management reports, biocompatibility testing, user training documentation, and more. “It took us six months just to rewrite the clinical evaluation for one infusion pump,” a Chinese manufacturer shared, noting that the MDR’s standard of “scientific evidence” is now comparable to that required in clinical trials.
Challenge 2: Limited Notified Body Resources
There are only a limited number of MDR-designated Notified Bodies in the EU, and for manufacturers outside of Europe, this often leads to longer communication cycles and higher application costs. Some companies report waiting 6 to 12 months just to enter the review queue.
Challenge 3: Language and Format Barriers
MDR-compliant documentation must adhere to strict formatting and terminology standards. In addition, instructions for use may need to be translated into multiple EU languages, adding further compliance burdens for exporters.
Structural “Opportunities” Hidden in Stricter Rules
While MDR appears to impose heavier burdens, it also creates opportunities for manufacturers with stronger technology, robust clinical data, and proactive compliance strategies.
Opportunity 1: A Higher Bar Creates Competitive Advantage
With stricter standards in place, lower-quality and copycat products are being naturally phased out. A medical device distributor in Poland noted, “We prefer to source MDR-certified products because it gives us confidence that the device has undergone rigorous safety assessments.”
Opportunity 2: Driving Product Innovation and Global Collaboration
Regulatory pressure is fueling innovation. Some Asian manufacturers are leveraging MDR as a catalyst to upgrade their products, partner with European R&D institutes, or even acquire EU-based brands to strengthen their clinical data portfolios. CE-marked products are also more easily accepted in Middle Eastern, African, and other markets that follow EU standards.
Opportunity 3: Enhancing Brand Credibility Internationally
As procurement decisions increasingly prioritize safety and compliance, MDR certification has become part of a brand’s international credibility. It can help companies gain access to high-end markets and build long-term trust with distributors and hospitals.
Final Word: Adaptation Matters More Than Complaints
MDR has undoubtedly rewritten the rules for global medical device access—especially in high-tech segments like OR equipment. For companies aiming to enter the EU, early planning, solid Notified Body partnerships, and long-term investment in clinical evidence will be key to success.
In an era where global medical compliance standards are tightening across the board, MDR is not merely a barrier—it’s a unique opportunity for industry-wide refinement and advancement.
