---
title: "The BCWG Published Version 5 of the Manual on Borderline and Classification Under MDR and IVDR"
description: "On 22 April 2026, the Borderline and Classification Working Group (BCWG) published Version 5 of the Manual on borderline and classification under MDR and IVDR, adding new borderline cases and classification examples agreed under the Helsinki procedure."
url: https://qbdgroup.com/en/regulatory-updates/bcwg-manual-borderline-classification-mdr-ivdr-v5
type: "Regulatory update"
language: en
published: 2026-04-22
author: "Kirsten Van Garsse"
category: "Medical Devices"
publisher: "QbD Group"
citation: "QbD Group, \"The BCWG Published Version 5 of the Manual on Borderline and Classification Under MDR and IVDR\", https://qbdgroup.com/en/regulatory-updates/bcwg-manual-borderline-classification-mdr-ivdr-v5"
---
# The BCWG Published Version 5 of the Manual on Borderline and Classification Under MDR and IVDR
> On 22 April 2026, the Borderline and Classification Working Group (BCWG) published Version 5 of the Manual on borderline and classification under MDR and IVDR, adding new borderline cases and classification examples agreed under the Helsinki procedure.

On 22 April 2026, the Borderline and Classification Working Group (BCWG) published Version 5 of the [Manual on borderline and classification under MDR and IVDR](https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf), introducing several new cases reflecting recent competent authority agreements under the Helsinki procedure.

**This update expands the Manual with additional practical borderline and classification examples**, helping to further harmonise interpretation across Member States.

Key new additions include:

- A new borderline case clarifying that devices used to administer medicinal products (e.g. packaging) may qualify as medical devices but, when forming an integral combination product, fall under medicinal product legislation with MDR Annex I compliance required (Article 117 context).
- New classification examples, including:
  - Penis holster classified as Class I (non-invasive, Rule 1)
  - Syringe containing glass beads classified as Class IIb under Rule 3
  - Needles for root canal irrigation classified as Class IIa (surgically invasive, Rule 6)
  - Saline solutions for nasal irrigation classified as Class IIa under Rule 21 (substance-based devices)

Overall, Version 5 provides additional clarity on borderline with medicinal products and on the application of MDR classification rules for specific device types, reinforcing a case-by-case, evidence-based approach.

## What does this mean for you?

**Manufacturers should ensure that their products, especially combination products and substance-based devices, are aligned with the latest borderline interpretations.**

In particular, products used to administer medicinal products (including packaging) should be correctly assessed for Article 117 applicability, while device classifications must be consistent with the emerging case examples introduced in the Manual.

In addition, technical documentation should clearly reflect these updated interpretations, ensuring that classification and qualification decisions are robust and defensible during notified body or competent authority review.

Overall, the update reinforces expectations for precise qualification and well-substantiated classification decisions, particularly in borderline or complex scenarios.
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Source: https://qbdgroup.com/en/regulatory-updates/bcwg-manual-borderline-classification-mdr-ivdr-v5 — © QbD Group. Quote freely with attribution and a link back.