August 2025 — PRRCs: Do You Really Have Systemic Oversight?
- Team Hoodin
- Aug 4
- 2 min read
Establishing full regulatory control and QMS integration
Under Article 15 of the MDR and IVDR, the Person Responsible for Regulatory Compliance (PRRC) is personally accountable for ensuring that regulatory requirements are systematically implemented and maintained.
This includes making sure that: – Technical documentation is current and traceable (Annex II Section 4) – All applicable regulations are known and monitored – Regulatory control is embedded into the QMS (ISO 13485 §4.1.3)
PRRCs are now facing the reality that manual tracking, static lists, and occasional reviews are not enough. Oversight must be real-time, structured, and defensible.
You may use AI tools such as ChatGPT, Gemini, CoPilot, or AI-enhanced regulatory tools such as Hoodin to monitor regulations, identify gaps, and produce audit-ready summaries that support system-level responsibility.
Operational Focus
Establish a live, product-specific regulatory oversight system — documented, monitored, and reviewable
To fulfil the obligations under Article 15 and ISO 13485 §4.1.3, you must: – Know what regulations apply – Show how they are monitored – Link them to product decisions and QMS processes – Demonstrate when and how updates were reviewed and acted upon
Step-by-Step Execution
Define current product-market scope For each product, confirm intended use, classification, and countries of distribution. These determine the regulatory footprint to monitor.
Generate the full Applicable List of Regulations Use AI to generate a list of applicable regulations per product and market, including: – MDR/IVDR and related delegated/implementing acts – National-level counterparts (e.g. UK MDR 2002, Swiss MedDO) – Cross-domain acts (GDPR, REACH, RoHS, cybersecurity) – Known deviations or local add-ons per country
Identify who owns oversight for each regulation Assign responsibility for each regulation’s monitoring, review, and documentation — especially where it links to PRRC responsibility or Annex II traceability
Ensure live monitoring and documentation For each regulation: – Track its revision status and historical versions – Document when updates are reviewed – Note how updates impact technical documentation or QMS
Prepare a PRRC oversight file Compile a summary that shows: – What’s monitored – How it’s linked to product files – When it was last reviewed – What action (if any) was taken
How Hoodin Helps
Hoodin’s Smart Compliance List supports PRRCs with: – Structured regulatory bundles per product and market – Continuous monitoring of 1,500+ global regulations – Automatic identification of updates and deviations – Audit-ready oversight reports and version history – Role-based visibility for PRRCs and compliance leads Start you 14-day free trial here
