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MDR Consulting for Small Enterprises

Ensuring compliance with the Medical Device Regulation (MDR) is crucial for businesses in the medical device industry. At 1M4, we specialize in supporting enterprises to navigate these complex regulatory requirements effectively.

Even if you are just starting to explore MDR compliance, we are the right partner to guide you. This includes businesses outside the EU that may be unfamiliar with the regulation. We help identify exactly what you need to achieve compliance—whether it’s understanding the basics, determining necessary documentation, or defining the next steps for your specific situation.

With 1M4, you can count on tailored support, whether you’re new to MDR or require expert assistance for ongoing compliance efforts.

External PRRC Support

For small and micro enterprises, Article 15 (2) MDR allows the appointment of an External Person Responsible for Regulatory Compliance (PRRC). While the external PRRC can provide expert guidance and oversight, the internal execution of responsibilities remains mandatory. We offer comprehensive consulting services to support you in meeting these obligations:

Advisory on PRRC Responsibilities: We explain the role and tasks of the PRRC and provide guidance to help your team implement these requirements internally.
Review of Technical Documentation (TD): We assess your technical documentation and EU Declaration of Conformity to ensure they meet MDR standards and are up to date.
Market Surveillance Compliance: We review your systems and processes for post-market surveillance (PMS) to ensure compliance with MDR requirements.
Vigilance Reporting Guidance: We advise on reporting obligations, including the management of incidents, trend analysis, and communication of safety information to relevant authorities.
Authority Liaison: We assist with understanding and fulfilling registration requirements, including EUDAMED entries, ensuring your business is aligned with regulatory expectations.

Key Areas of Support

Pre-Market Conformity Checks: Before your products are released, we review their compliance with your quality management system and the MDR requirements.
Ongoing Compliance Oversight: We assess processes and documentation to ensure your business meets obligations such as PMS and vigilance requirements.
Multilingual Consulting: We provide advice in German and English, ensuring clear communication regardless of your team’s primary language.

Important Notes on External PRRC Services

As an external PRRC, our role is advisory and oversight-focused. The execution of all regulatory tasks—such as updating and maintaining technical documentation (TD), declarations of conformity (DoC), PMS reports, and safety documentation—must be performed by your internal team. Our services are designed to ensure that your internal team has the knowledge and tools required to fulfill these responsibilities efficiently.

Why Work With Us?

Specialized Expertise for Small Enterprises: We understand the unique challenges faced by small and micro businesses and tailor our services accordingly.
Comprehensive Support: From reviewing your processes to advising on regulatory requirements, we help you build confidence in your compliance efforts.
Focus on Collaboration: We empower your internal team to execute their responsibilities effectively while providing the external expertise needed to ensure accuracy and compliance.

Ready to Ensure MDR Compliance?

With our consulting services, your business will gain the clarity and confidence to meet MDR requirements effectively. Contact us today to learn more about how we can assist with your PRRC needs and help your team achieve full compliance.

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