Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial intelligence. The MDR answers the first; a fast-moving set of regulations answers the second.
The Person Responsible for Regulatory Compliance
Under Article 15, every manufacturer must have at least one Person Responsible for Regulatory Compliance (PRRC) with appropriate expertise. The current qualification requirement is either a relevant degree plus at least one year of regulatory or quality experience with devices, or four years of such experience.
The PRRC ensures conformity is properly checked before release, that technical documentation and the declaration of conformity stay current, and that post-market and vigilance obligations are met. Micro and small enterprises need not employ a PRRC on staff but must have one permanently at their disposal — and authorised representatives must always have one available.
The Commission’s December 2025 proposal would simplify Article 15 — replacing the detailed qualification criteria with a general “requisite expertise” test and clarifying that the PRRC may act on a contractual basis rather than as an employee. As with the rest of that package, it is a proposal and not yet in force.
Software as a Medical Device
Software that meets the definition of a medical device is regulated like any other device, and is classified mainly under Rule 11 — which pushes most clinical decision-support software to Class IIa or higher. Guidance document MDCG 2019-11 sets out how the rule is interpreted.
Where AI meets the MDR
AI-based devices now sit at the intersection of two regimes. Under the EU AI Act (Regulation (EU) 2024/1689), an AI system that is a medical device — or a safety component of one — and requires notified body assessment under the MDR is treated as a high-risk AI system. That layers obligations on risk management, data governance, transparency, human oversight and logging on top of the MDR. Guidance (MDCG 2025-6) has begun to clarify how the two frameworks align.
How PQRA helps
PQRA provides PRRC support, software classification and the regulatory strategy for AI-enabled devices across the MDR and AI Act.
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