---
title: "New MDR Updates for Well-Established Technologies"
description: "On 29 June 2026, two new Delegated Regulations amending the MDR (EU) 2017/745 were published, expanding exemptions for well-established medical device technologies from notified body technical documentation assessment and from mandatory clinical investigations."
url: https://qbdgroup.com/en/regulatory-updates/mdr-updates-well-established-technologies-2026
type: "Regulatory update"
language: en
published: 2026-07-02
author: "Kirsten Van Garsse"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"New MDR Updates for Well-Established Technologies\", https://qbdgroup.com/en/regulatory-updates/mdr-updates-well-established-technologies-2026"
---
# New MDR Updates for Well-Established Technologies
> On 29 June 2026, two new Delegated Regulations amending the MDR (EU) 2017/745 were published, expanding exemptions for well-established medical device technologies from notified body technical documentation assessment and from mandatory clinical investigations.

On 29 June 2026, two new Delegated Regulations amending the Medical Device Regulation (EU) 2017/745 (MDR) were published in the Official Journal of the EU: [Commission Delegated Regulation (EU) 2026/1359](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359), **expanding the list of Class IIb implantable devices** exempt from notified body technical documentation assessment for every device, and [Commission Delegated Regulation (EU) 2026/1451](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451), **expanding the list of implantable and Class III devices** exempt from the obligation to perform clinical investigations.

Both Regulations are based on the recognition that certain established device technologies have **demonstrated consistent safety and performance** over many years of clinical use and therefore may warrant a more proportionate regulatory approach.

## Key Updates

### Expanded exemption from technical documentation assessment

Delegated Regulation (EU) 2026/1359 expands the list of Class IIb implantable devices exempt from the requirement that notified bodies assess the **technical documentation** of every individual device during conformity assessment.

Newly added examples include:

- Cannulas and catheters
- Feeding tubes and gastrostomy buttons
- Bone wax, bone fillers and bone substitutes
- Dental implants and orthodontic devices
- Anchors, nails and spinal posterior fixation devices
- Textile braids, suspensory fixations and cinches

### Expanded exemption from clinical investigations

Delegated Regulation (EU) 2026/1451 expands the list of implantable and Class III devices that may be exempt from performing **clinical investigations**, provided that:

- sufficient clinical data are available,
- the clinical evaluation complies with applicable Common Specifications (where available), and
- MDR clinical evaluation requirements remain fulfilled.

The expanded list includes many well-established technologies, such as:

- Cannulas and specialised catheters
- Feeding tubes and gastrostomy buttons
- Bone fillers and bone substitutes
- Dental implants, dental veneers and orthodontic devices
- Reusable surgical instruments
- Guidewires, pacing wires and leads
- Endovascular embolisation coils and embolisation particles
- Shunts and internal defibrillation paddles

Importantly, manufacturers remain required to perform and document a clinical evaluation in accordance with MDR Article 61.

## A More Proportionate, Risk-Based Approach

These amendments reflect the Commission's intention to apply **a more proportionate and risk-based regulatory approach to well-established technologies.**

For qualifying devices, manufacturers may benefit from:

- Reduced notified body review requirements for certain Class IIb implantable devices
- Reduced need to generate new clinical investigation data where sufficient clinical evidence already exists
- More efficient conformity assessment activities while maintaining high levels of safety and performance

The updates acknowledge that some **mature technologies no longer require the same level of regulatory scrutiny** as novel or rapidly evolving devices.

## What Does This Mean for You?

Manufacturers should assess whether any products in their portfolio qualify as well-established technologies under the expanded exemption lists.

For affected devices, the changes may influence:

- Clinical evidence strategies
- Clinical investigation planning
- Technical documentation requirements
- Notified body interactions
- Certification timelines and resource allocation

However, manufacturers should note that the exemptions do not remove the obligation to maintain robust clinical evaluations and supporting evidence demonstrating compliance with MDR requirements.
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Source: https://qbdgroup.com/en/regulatory-updates/mdr-updates-well-established-technologies-2026 — © QbD Group. Quote freely with attribution and a link back.