ADDE Regulatory Context: Essential Updates for European Dental Distributors

From the ADDE Regulatory Affairs Department

As ADDE members are mainly distributors, this newsletter called "Regulatory context" is primarily intended for them. However, many regulations for manufacturers now affect, and increasingly, both manufacturers and distributors. So sometimes this newsletter will also be useful to manufacturers.

Tamara FAYOLLE
ADDE Regulatory Affairs Department

"This document serves only as an additional tool at your disposal in a regulatory environment that changes very regularly. Furthermore, as information unfortunately quickly becomes obsolete, we invite you to consult professionals in this field.

While waiting for a fantasy world where we can operate in a predictable or at least understandable environment, each month, we will provide you with a short list of topics that may be interesting to those distributing healthcare products in Europe in our dental sector."

Contents of This Issue

• 🌍 Do you have some time to travel? Brussels and Valletta are nice places

• ⚖️ Classification - Are you borderline?

• 📋 In my briefcase of documents - For each medical device you sell

• 📊 ISO 9001 September 2026 - Not so far away

• 🧪 REACH Regulation – Concerned

• 📚 Build your library

🌍 Upcoming Conferences: Brussels and Valletta

The regulatory landscape offers valuable learning opportunities through specialized conferences and training events. Here are key upcoming events for regulatory professionals in the medical device sector:

Major Events for Regulatory Professionals

Medical Device Clinical Training and Education
A major event focusing on clinical training and education for medical device regulatory professionals.
🔗 https://eu.medtechclinicaleducation.com/

4th Annual Medical Device and Diagnostic Regulatory Affairs Conference
📅 12-14 November 2025
🔗 https://regulatoryaffairssummit.com/

Medtech Conference
📅 12-14 November 2025 | 📍 Valletta, Malta

⚖️ Classification: Are You Borderline?

The Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been updated in September 2025. This update brings crucial clarifications for distributors dealing with borderline products.

🔴 Product for Professional Removal of Dental Biofilm

Products with medical intended purpose based on claims regarding attenuation of inflammation (gingivitis, periodontitis, and peri-implantitis) face classification challenges. However, the antimicrobial action of ROS, considered as the principal intended action, should be considered pharmacological, immunological or metabolic mode of action.

⚠️ Key Ruling: The ECJ ruling of 6 September 2012, case C-308/11, supports that antimicrobial actions on the human body should be considered pharmacological. Consequently, considering the principal mode of action, this product should not be qualified as a medical device.

Regarding prefilled syringes: When a device and medicinal product form a single integral product intended exclusively for use in combination and which is not reusable, it shall be governed by Directive 2001/83/EC.

🔴 Root Canal Irrigation Solutions

Sodium hypochlorite (NaOCl) and chlorhexidine (CHX) are substances with antimicrobial properties. Both are medicinal substances with documented pharmacological effects.

If the manufacturer can demonstrate that the principal mode of action is rinsing and irrigation (mechanical action) to remove debris and necrotic tissues, the irrigating solutions fulfill the medical device definition.

⚠️ Critical Classification: Unless the manufacturer provides robust scientific evidence that NaOCl or CHX has no antibacterial or antiseptic action in or on the human body, root canal irrigating solutions containing these substances should be classified as Class III per rule 14 of Annex VIII to the MDR.

🔴 Microabrasion Dental Stain Removers

The removal of dental stains to improve the appearance of teeth does not represent a medical purpose, regardless of the method or technique utilized and regardless of whether staining results from disease or treatment.

Important: Products used for improving the appearance of teeth do not comply with the legal definition of medical device established in the MDR and should not be qualified as medical devices.

📋 In My Briefcase: Essential Documents for Medical Device Distribution

Why These Documents Matter

You are any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market. Therefore, you must verify compliance of the medical devices you sell and obtain copies of documents to fulfill your obligations.

Source: Regulation 2017/745

✓ Required Documentation for Each Medical Device:

• ✓ CE and EU marking - Declaration of conformity

• ✓ SRN number - Eudamed registration (IT system developed by the European Commission)

• ✓ Labeling and instructions - Required information per Article 10, §11, Annex 1, Section 23

• ✓ UDI (Unique Device Identification) - Complete list

• ✓ Applicable regulations - List and documentation

These documents provide a higher level of assurance of compliance and are essential for your regulatory briefcase.

📊 ISO 9001 September 2026: Preparation Time

🟢 Climate Change and Quality Culture

Amendment A1:2024 placed climate change as a strategic topic. The new version of the standard will also include quality culture and ethical behavior.

This Draft International Standard is currently in the enquiry phase with ISO members worldwide reviewing and providing feedback before finalization.

"An opportunity to review and refine your quality management system, ensuring it aligns with updated requirements and stakeholder expectations. Certified organizations will have a transition period to adapt."
— Source: Committee TC 176

This revision ensures the standard remains relevant, addressing modern business needs and stakeholder expectations.

🧪 REACH Regulation: Medical Devices Are Concerned

Essential REACH Compliance

REACH regulation ensures your medical devices meet EU regulations for chemical safety. Medical Devices are not fully exempt from REACH. Check with your manufacturer - you need this information also for customs procedures.

🟡 Upcoming Training Opportunity

REACH Registration Webinar
📅 22 October 2025, 11:00 - 17:00

Topics:

• Understanding registration obligations

• Determining registration requirements

• Guidance and tools for compliance

🔗 ECHA Website
🔗 YouTube Live

📚 Build Your Library

A number of different topics are relevant for the implementation of Medical Device Regulations:

• Reprocessing procedures

• Custom-made devices

• In-house medical devices

• Software and apps

• Biocidal products

⚠️ Biocides Alert

Don't forget some distributors also sell Biocides. The evaluation of the Biocidal Products Regulation that started this year may bring a more "clear, stable and predictable regulatory framework." Be careful - the Regulation contains provisions that apply not only to biocidal products but to articles and mixtures that have been treated with, or incorporate, a biocidal product.

Source: Regulation (EU) 528/2012

"Let's understand the regulation today and prepare tomorrow together"
— REACH Regulation: Detect changes to reduce risks

About This Regulatory Bulletin

Published by: ADDE (Association of Dental Distributors in Europe)
Regulatory Affairs Department: Tamara FAYOLLE
Issue: 2025 – n°1
Purpose: Providing monthly regulatory updates for dental distributors in Europe

Key Regulatory References

• Regulation (EU) 2017/745 on medical devices (MDR)

• Regulation (EU) 2017/746 on in vitro diagnostic medical devices

• Manual on borderline and classification for medical devices (Updated September 2025)

• MDCG-2022-5 guidance documents

• ISO 9001 Draft International Standard (Committee TC 176)

• REACH Regulation - ECHA guidance

• Regulation (EU) 528/2012 on Biocidal Products

• Directive 2001/83/EC on medicinal products

• ECJ ruling 6 September 2012, case C-308/11

Disclaimer

This newsletter serves as an additional regulatory tool. As information quickly becomes obsolete in our changing regulatory environment, please consult regulatory professionals for specific compliance guidance. ADDE provides this information for educational purposes and recommends professional regulatory consultation for business decisions.

For questions or more information, please contact the ADDE Regulatory Affairs Department.