PRRC Liability: What Happens If You Get It Wrong?
Italian Competent Authority PRRC Update and Findings from Industry
The Italian Ministry of Health briefed us on their findings in the implementation of Article 15.
Some of these that feel salient to mention are:
The competent authority identified that PRRCs often lack sufficient authority, resources and autonomy - keep the word authority in mind.
They also identified that there is also unclear management of outsourcing to micro and small enterprises.
Regulatory burden and Workload -Complexity and responsibilities under MDR without proportional resource must handle conformity, post-market surveillance, vigilance, and documentation.
Inconsistent updating of regulatory reports and records (EUDAMED).
Furthermore, do you also know that in Italy, the PRRC can be held liable with financial penalties?
PRRC Breach of Obligations (Italy, Legislative Decree 137/2022, Art. 27, comma 17) • Unless the offence constitutes a crime, a PRRC who fails to comply with the obligations set out in Article 15(3) MDR is subject to an administrative fine from €20,000 to €120,000.
Wild eh?
Sandra Ferretti, Lead Representative for Italy, TEAM-PRRC & Piero Costa, Representative for Italy, TEAM-PRRC took us through an excellent country by country summary of the financial penalties that the manufacturer may face if they do not appoint a PRRC. Sean Smith covers this wonderfully in this article - https://www.linkedin.com/pulse/national-legal-frameworks-sanctions-prrcs-europe-sean-smith-nzkoe/?trackingId=K5HoR65uL5JzkwSWeTlsug%3D%3D
Regulatory Targeted Evaluation
Furthermore, the Italian Competent Authority gave an update on their role within the targeted evaluation that is currently underway and their wish list. I will summarise the main things that stood out to me below:
DISCLAIMER: none of these are confirmed currently
Reducing Administrative Burdens
Streamlining reporting by manufacturers - SSCP and PSURs
Extend reporting timelines for “ordinary” vigilance notifications (from 15 to 30 days)
Improving predictability and cost-efficiency of certification
Introduce preliminary dialogue between manufacturers and notified bodies
Expand the possibility of remote audits
Ease the assessment of technical documentation for low/medium risk devices through sampling
Differentiate between changes requiring notified body approval and those implementable directly by the manufacturer - particularly salient for SAMD
Conduct unannounced audits only “for cause”, not every 5 years
Reduce consultation times with medicines and human-origin substances (SoHO) authorities
More proportional MDR/IVDR requirements
Removing maximum validity period of certificates while maintaining surveillance
Define specific criteria for WET devices
Reduce of eliminate the involvement of notified bodies for low risk devices such as class 1 reusables
Adapt conformity assessment procedures for orphan devices
Review classification rules
Introduce exemptions for devices needed in health emergencies
Allow exemptions from UDI and Eudamed registration based on device characteristics
Supporting innovation
Adapt conformity assessment procedures for innovative (breakthrough) technologies
Introduce designation by expert panels
Provide for priority assessment by selected notified bodies
Offer support from expert panels for pre- and post-market clinical evidence
Define specific conditions for certification (e.g., limited validity, PMCF activities)
Monitor progress through the MDCG
Introduce national-level regulatory sandboxes for regulatory experimentation
Simplify requirements for in-house devices manufactured and used by healthcare institutions
It was also laid down that we can expect a significant update on the targeted evaluation by 16th December 2025, which may or may not address that covered above.
A key word that was used throughout the two days of the conference with regards to MDR and IVDR was PREDICTABILITY.
EUDAMED
Richard Hoolihan took us through some updates on EUDAMED.
Things are looking positive and we can can expect the Official Journal of the European Commission (OJEC) to be published with the UDI module in November 2025, therefore it will be mandatory in 6 months of this being published.
On the Vigilance module, at the moment is looking like November 2026.
For Market Surveillance, this looks like it may be mandatory Q2 2026.
For Clinical Investigations, this looks like it may be mandatory by Q4 of 2027.
Massive disclaimer again that all of these can change by the time you finish this sentence.
TEAM NB Update
Francoise Schlemmer from TEAM NB provided a great update on their role within the targeted evaluation, here is a summary of what was discussed and what has been tabled.
6 task forces were established covering the following, I’ll go into some detail on the main ones I find most interesting and aligned with other elements mentioned by the Italian Ministry of Health:
Early dialogue
Article 61.10 & WET
Digitalisation
Coding for MD and IVD
Designation and recertification
Breakthrough
Article 61.10 & WET
The proposal aims to redefine the criteria for applicability of Article 61 (10) and clarify its application.
Broaden the definition of clinical data (Article 2(48)) to include real-world evidence, post-market data, and relevant international sources.
Redefine clinical evaluation (Article 2(44)) and clinical evidence (Article 2(51)) to include clinical relevant non-clinical data.
Clarify that clinical evaluations and typically based on clinical data but may incorporate other relevant data.
Issue MDCG guidance to reflect a more holistic understanding of “sufficient clinical evidence”
Digitalisation
Establish legal basis for a digitalised MDR/IVDR
Data instead of documentation; but maintain flexibility - both documentation and/or data accepted
Open access to digial formats - data definitions, data models etc.,
Mode “inclusive” wording to encourage use of digital tools for QMS, Technical Documentation
Enable future data-based conformity assessments - AI tools for conformity assessment but with a human in loop
Enable use of remote and hybrid audits where appropriate
Explicit mentioning of in silico methodologies for simulation
Development and use of regulatory sandboxes for testing ideas and/or devices
Recertification
Unlimited certificate validity with periodic checkpoints:
Certificates uploaded to EUDAMED and will display only the issuance date, no expiry.
At predefined intervals (5, 10 years for example after issuance), certificates will automatically become invalid in EUDAMED unless revalidated by NB.
EUDAMED will maintain complete certificate history
The maximum interval between issuance and first checkpoint and subsequent checkpoints is 5 years
NBs may set shorter intervals, especially for Special Pathway Devices (innovative, orphan or breakthrough)
Breakthrough
Legal text to include definitions of Breakthrough, Orphan and Paediatric devices in Article 2 of MDR/IVDR, or into guidance.
Introduction of new text in relevant conformity assessment articles and potentially introduce a new annex for special pathways covering:
Eligibility criteria for devices in special pathway.
Minimum data requirements acknowledging that sufficient pre-market data under MDR/IVDR collection may not be feasible.
Optionally, criteria and datasets may be tailored per device group.
Conditional approval of devices with expert panel roles included
AI ACT
Proposal by TEAM NB is a harmonised assessment of high risk AI products/devices to avoid duplication of conformity assessment and increase cost efficiency for these devices.
All very logical if you ask me.
Liability
Alex Denoon and Erik Vollebregt took us through a liability case, in the context of the PRRC.
This is always a very interesting topic, considering the role of the PRRC and brings up the real nuance details of conflicts of interests, responsibilities vs authorities and negligence vs criminal damage.
The PRRC in many circumstances has their hands tied.
The emphasis on having a strong insurance policy as the PRRC was highlighted, as well as a run off period post-termination of the contract to ensure nothing can come back on the PRRC.
This was extremely engaging, as per any talk that you will attend by Alex and Erik.
More to come on all of this.
Ciao!