# Meeting Minutes

## Metadata

| | |
|---|---|
| Organisation | Not stated |
| Reference | Not stated |
| Meeting | T819 DITA Eyewear Importer Obligations - Client connect |
| Date | Not stated |
| Duration | Not stated |
| Attendees |  |

## Objectives

Clarify DITA importer-obligation processes, business workflows and regulatory gaps so Trinzo can build usable compliance documents and follow-up actions.

## Executive Summary

The client call clarified DITA’s product and information flow from Japanese suppliers through Netherlands fiscal clearance to Park West storage and European dispatch. The team discussed how QMS procedures should match real business processes, and reviewed UDI, lot numbering, label design, EUDAMED responsibilities, MedEnvoy oversight, DoCs, language considerations and HPRA fees. The internal follow-up added scope clarity around sunglasses/PPE, working-session planning, site-visit planning and the need for client clarification questions.

## Key Discussion Points

| Topic | Discussion | Outcome |
|---|---|---|
| Topic 1 | The QMS manual is being used as a building block for importer-obligation compliance documents. | See discussion |
| Topic 2 | DITA's product flow involves goods purchased from suppliers in Japan, fiscally cleared in the Netherlands and then shipped to Dublin. | See discussion |
| Topic 3 | The Netherlands step is a short customs or airport clearance hold rather than substantive warehousing. | See discussion |
| Topic 4 | Final storage takes place at DITA's Park West warehouse in Dublin. | See discussion |
| Topic 5 | The Park West warehouse is mostly manual, with scanners and RF Smart handheld devices used for picking. | See discussion |
| Topic 6 | Customer orders can come through B2B, sales reps or customer service and are processed through ERP and warehouse picking flows. | See discussion |
| Topic 7 | Products are picked, packed into branded cases, labelled, invoiced and dispatched through DHL to stores. | See discussion |
| Topic 8 | The QMS and procedures need to reflect both regulatory requirements and DITA's actual business processes. | See discussion |
| Topic 9 | Orla had not received the QMS manual email, so it needs to be resent to her. | See discussion |
| Topic 10 | Current barcode use is UPC-based, with lot numbering and UDI-related updates being implemented. | See discussion |
| Topic 11 | New products must be registered in EUDAMED immediately and existing products by 28 November. | See discussion |
| Topic 12 | Importer and authorised representative obligations include checking that manufacturer product data is present in EUDAMED. | See discussion |
| Topic 13 | MedEnvoy may be handling EUDAMED device registration for the manufacturer, but DITA needs oversight of the plan and timelines. | See discussion |
| Topic 14 | US FDA GUDID records may also need to be checked for distributed US products. | See discussion |
| Topic 15 | Label updates should include production information, potentially through a 2D data matrix barcode and lot number. | See discussion |
| Topic 16 | Manufacturer information notes or warranty booklets are used, but the team discussed whether any IFU justification is needed from the manufacturer. | See discussion |
| Topic 17 | Class I glasses may not need IFUs if justified, but the manufacturer needs the rationale if no IFU is provided. | See discussion |
| Topic 18 | Declaration of conformity updates may need to include sunglasses and risk rationale for both EU MDR and PPE Category I. | See discussion |
| Topic 19 | DOC translation and country/language coverage need to be clarified based on where products are shipped. | See discussion |
| Topic 20 | The HPRA authorised representative invoice and SRN registration correspondence need to be reviewed before payment. | See discussion |

## Actions

| Owner | Action | Due |
|---|---|---|
| Jacqui | Resend the QMS manual to Orla. | Not stated |
| Orla | Review the QMS manual this week and raise any questions. | Not stated |
| Orla | Speak to Cody about the MedEnvoy task list, EUDAMED registration plan and who is responsible for each activity. | Not stated |
| Orla | Share or confirm the list of countries DITA ships to so language and DOC translation requirements can be checked. | Not stated |
| Orla | Continue work with suppliers and RF Smart on lot numbering and label updates over the next two to three weeks. | Not stated |
| Jenny | Review label or barcode details if DITA wants a regulatory check on the proposed format. | Not stated |
| John-Paul | Update declarations of conformity for sunglasses to include the required risk rationale for EU MDR and PPE Category I where applicable. | Not stated |
| Orla | Send the HPRA invoice and SRN confirmation email to Jacqui and Colm for review. | Not stated |
| Jacqui and Colm | Review the HPRA invoice and SRN correspondence with Liam before payment guidance is given. | Not stated |
| Jacqui | Arrange a follow-up call with Orla for the following week. | Not stated |