# Meeting Minutes

## Metadata
| | |
|---|---|
| Client | Meridian Ortho |
| Reference | T802 |
| Meeting | Tech File review — weekly |
| Date | Wednesday 1 July 2026, 09:00 |
| Duration | 17m 51s |
| Attendees | Jacqui Fox, Rebecca Gill, David Didsbury (Trinzo); Ffion Hargreaves, Dermot Nally, Sanjay Iyer (Meridian Ortho) |

## Objectives
Review progress against the technical file tracker across risk, software, UDI, clinical evaluation, supplier agreements and labelling, and agree owners and dates for the coming week.

## Executive Summary
Tracker movement was the strongest of the project to date, with eight documents leaving the not-started column, though most of this was the labelling pack rather than substantive documents. Risk remains blocked pending David Didsbury's written comments on the risk management plan, which identified two defects: overlapping wording between the top two severity bands, and no rationale anywhere for what constitutes an "event" in the probability bands. Rebecca Gill will build the matrix structure this week and populate it once those comments land.

The most significant new issue is clinical evaluation. Meridian's clinical evaluator is absent until September, leaving the CER update stalled at roughly 60% with the literature search complete but the appraisal and conclusions outstanding. Jacqui Fox will propose a Trinzo resource with a name and rate by 2 July. Separately, Sanjay Iyer identified a duplicate basic UDI-DI whose origin is not yet understood, and Dermot Nally proposed splitting the navigation app into two software items with different safety classifications — a proposal that is not yet signed off by anyone and requires written justification.

## Key Discussion Points
| Topic | Discussion | Outcome |
|---|---|---|
| Tracker status | 41 documents in the not-started column last week, 33 this morning. Eight moved, largely the labelling pack, which are short documents. Two per week has been the run rate since May. | Noted; movement acknowledged as real but not as large as the headline suggests |
| Risk management plan | David Didsbury has read the plan but not written up. Two findings: the catastrophic and critical severity bands are described almost identically and cannot be reliably distinguished; and the probability bands are the standard 14971 set with no statement of what an event is (per device, per procedure, per patient). | Comments to be written up; matrix population blocked until then |
| Risk matrix | Population is blocked but structure is not. | Rebecca Gill to build the shell this week and populate after comments |
| Software classification | Dermot Nally has split the navigation app into a planning module (proposed Class B) and an intraoperative display (proposed Class C). Nobody has signed this off. David Didsbury advised that the justification for why the planning module cannot contribute to a hazardous situation must be written down before it reaches the notified body, and that it belongs in the software development plan rather than a new document — two or three paragraphs. | Justification to be drafted; Marcus to review |
| UDI | 18 of 22 references correct in EUDAMED. Three are wrong because of the March packaging configuration change and need new DIs. The fourth, the 8mm reference, appears twice under two different basic UDI-DIs; Ffion Hargreaves suggested this may date from when the reference was submitted by the distributor before being brought in house. | Three new DIs this week; duplicate under investigation with no committed date |
| Clinical evaluation | Meridian's clinical evaluator is off until September. The CER draft is around 60% complete. The literature search is done and documented; the appraisal and conclusions are not, and cannot be completed internally. | Jacqui Fox to check availability of a Trinzo evaluator and respond with a name and rate |
| Supplier agreements | Outstanding three weeks, chased twice. Two coating supplier agreements are with legal; seven others are complete. | Agreed to release the seven now rather than wait for the full set |
| Labelling and IFU | Symbols review complete; two symbols on the outer carton are no longer in 15223 and are being removed. IFU is with translators in 24 languages, due back around 18 July. The Polish and Portuguese distributors have said they have no resource for the local checking step this year. | Distributor checking flagged as a risk for August; Ffion Hargreaves to establish what the two distributors would need |
| Tracker hygiene | Owner column is inconsistent — some rows name a person, some name "Meridian". | Named owners to be added throughout |

## Actions
| Owner | Action | Due |
|---|---|---|
| David Didsbury | Write up comments on the risk management plan covering the severity band wording and the missing probability event definition | Fri 3 July |
| Rebecca Gill | Build the risk matrix structure, ready for population once comments are received | Week commencing 29 June |
| Dermot Nally | Draft the software classification justification into the software development plan and have Marcus review it | Wed 15 July |
| Sanjay Iyer | Create and submit new DIs for the three references affected by the March packaging change | This week |
| Sanjay Iyer | Investigate the duplicate basic UDI-DI on the 8mm reference, starting with the distributor correspondence | Open — no date committed |
| Jacqui Fox | Confirm availability of a Trinzo clinical evaluator and come back with a name and a rate | Thu 2 July |
| Ffion Hargreaves | Send the seven completed supplier agreements without waiting for the two with legal | Afternoon of 1 July |
| Rebecca Gill | Review the supplier agreements on receipt and flag if the volume is unmanageable alongside the matrix | On receipt |
| Ffion Hargreaves | Establish what the Polish and Portuguese distributors would need in order to perform the IFU checking step | Open |
| Ffion Hargreaves | Replace "Meridian" with named owners in the tracker owner column | Open |
| Jacqui Fox | Issue minutes and raise the clinical evaluation resourcing risk with Ffion Hargreaves separately by email | 1 July |