Patrick Gora Highlights Strategies for Small and Medium-Sized Enterprises (SMEs) to Comply with EU MDR

The European Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745) has introduced significant changes to the regulatory landscape for medical device manufacturers operating in the European Union (EU). The regulation, which replaced the Medical Device Directive (MDD), imposes stricter requirements on clinical evaluation, post-market surveillance, technical documentation, and overall compliance. While large corporations have the resources to navigate these complexities, small and medium-sized enterprises (SMEs) often struggle due to limited financial and personnel resources.

To help SMEs successfully comply with EU MDR, Patrick Gora of Rochester outlines key strategies, from understanding classification changes to optimizing regulatory workflows and leveraging external expertise.

1. Understand the Classification of Your Device

One of the fundamental steps in EU MDR compliance is determining the correct classification of your medical device. Patrick Gora explains that the regulation introduces a more stringent risk-based classification system, with many devices now subject to higher scrutiny.

• Review the updated classification rules in Annex VIII of the EU MDR.
• Identify whether your device has moved to a higher class. Certain software, implantable devices, and reusable surgical instruments now fall under stricter categories.
• Consult with a Notified Body (NB) early in the process to confirm your classification and regulatory pathway.

SMEs should invest time in understanding these classification changes to avoid delays or unexpected compliance challenges.

2. Strengthen Technical Documentation and Clinical Evidence

EU MDR places a stronger emphasis on robust technical documentation and clinical evaluation. SMEs must ensure that their documentation aligns with the new requirements.

• Revise technical files to meet General Safety and Performance Requirements (GSPR).
• Enhance clinical evaluation reports (CERs) by gathering sufficient clinical data to demonstrate safety and performance.
• Leverage existing post-market data and conduct additional studies if necessary.

For SMEs with limited resources, collaborating with contract research organizations (CROs) or seeking guidance from consultants can help meet these documentation standards efficiently.

3. Engage with a Notified Body Early

Notified Bodies play a critical role in the EU MDR approval process, Patrick Gora understands that as they are responsible for assessing conformity with the regulation. Due to the increased demand for their services, securing an early engagement is crucial.

• Identify an MDR-designated Notified Body that aligns with your product category.
• Schedule pre-submission meetings to understand expectations and documentation requirements.
• Plan for longer review timelines due to bottlenecks in Notified Body capacity.

Early and proactive engagement with a Notified Body can prevent last-minute hurdles that could delay market access.

4. Implement a Post-Market Surveillance (PMS) System

EU MDR requires manufacturers to establish a robust post-market surveillance (PMS) system. Unlike the previous directive, Patrick Gora of Rochester explains that PMS is now a continuous and proactive process.

• Develop a systematic PMS plan that includes data collection, risk management, and reporting.
• Regularly update your Post-Market Clinical Follow-up (PMCF) to identify emerging risks and ensure device safety.
• Submit Periodic Safety Update Reports (PSURs) or Post-Market Surveillance Reports (PMSRs), depending on the device classification.

For SMEs, digital solutions and automated data collection tools can streamline PMS processes and reduce the manual burden.

5. Ensure Compliance with Unique Device Identification (UDI) and Labeling

Under EU MDR, Unique Device Identification (UDI) is mandatory for all medical devices to improve traceability and patient safety. SMEs must ensure compliance with the new labeling and registration requirements.

• Assign UDIs to all medical devices and ensure they are correctly placed on labels.
• Register product information in the European Database on Medical Devices (EUDAMED).
• Review labeling requirements to include additional information, such as warnings and safety instructions.

Using regulatory software solutions can help SMEs manage UDI and labeling compliance effectively.

6. Train Employees on EU MDR Compliance

Compliance with EU MDR is not just a regulatory task—it requires a company-wide effort. Patrick Gora of Rochester explains that SMEs must ensure that their teams are well-versed in the new regulations.

• Conduct training sessions for regulatory affairs, quality assurance, product development, and customer support teams.
• Develop an internal compliance checklist to track progress on regulatory requirements.
• Stay updated on evolving regulatory guidelines by attending industry seminars and webinars.

Patrick Gora of Rochester emphasizes that by fostering a compliance-oriented culture, SMEs can reduce the risk of non-conformities and streamline regulatory adherence.

7. Utilize Regulatory Consultants and Digital Compliance Tools

Given the complexity of EU MDR, SMEs can benefit from external expertise and technology-driven solutions.

• Hire regulatory consultants with experience in MDR compliance to guide documentation and submissions.
• Invest in digital compliance software to manage documentation, risk assessment, and post-market activities.
• Collaborate with industry associations such as MedTech Europe to gain insights and best practices.

For SMEs with limited in-house regulatory expertise, leveraging external support can expedite compliance while minimizing risks.

8. Plan for Financial and Resource Allocation

Compliance with EU MDR can be costly, especially for SMEs. Companies must plan for financial and resource allocation to meet regulatory demands.

• Budget for certification costs, clinical evaluations, and Notified Body fees.
• Consider seeking government grants or funding programs available for SMEs in the medical device industry.
• Optimize internal resources by cross-training employees and streamlining compliance workflows.

Patrick Gora of Rochester explains that a well-structured financial plan can prevent unexpected setbacks and ensure sustained compliance.

EU MDR compliance is a complex and resource-intensive process, particularly for SMEs. Patrick Gora understands that by adopting a proactive approach, leveraging expert guidance, and utilizing regulatory technology, SMEs can navigate these challenges effectively. Understanding device classification, strengthening technical documentation, engaging with a Notified Body early, implementing post-market surveillance, and ensuring proper labeling are crucial steps. Additionally, investing in employee training, digital compliance tools, and financial planning will help SMEs meet regulatory expectations without compromising their business operations.

While the transition to EU MDR is demanding, compliance ensures improved patient safety, market credibility, and long-term sustainability for SMEs in the medical device industry. Patrick Gora of Rochester emphasizes that by embracing strategic planning and continuous regulatory adaptation, SMEs can successfully maintain access to the European market while fostering innovation and growth.