Navigating EU Regulations in the Dental Industry

Understanding the Framework That Shapes Our Industry

The European Union has introduced two cornerstone legislations reshaping the regulation of dental and medical devices:

• Medical Device Regulation (MDR 2017/745)

• In Vitro Diagnostic Regulation (IVDR 2017/746)

These frameworks strengthen product safety, traceability, and post-market accountability — ensuring that dental professionals and patients can trust the products distributed across Europe.

How EU Regulations Affect Distributors and Associations

The new regulations redefine the responsibilities of all economic operators within the dental supply chain — from manufacturers to distributors and importers.

For Distributors

✔️Obligation to verify CE marking and product documentation

✔️Ensure traceability and correct labelling under MDR/IVDR

✔️Maintain distribution records and complaint handling systems

For Associations

✔️Provide education and best-practice guidance to members

✔️Act as a liaison between industry and EU institutions

✔️Promote understanding of MDR and IVDR obligations

✔️Increased requirements for clinical evidence

✔️More rigorous technical documentation

✔️Cooperation with distributors to ensure regulatory compliance

For Manufacturers & Importers:

Representing the Voice of European Dental Distribution

ADDE’s Work Includes:

• Regular participation in EU policy consultations and stakeholder groups

• Publication of guidance documents and position papers on MDR/IVDR

• Collaboration with national associations for consistent implementation

• Hosting regulatory workshops and annual forums

• Acting as a bridge between regulators and the distribution community

ADDE actively monitors and contributes to the development of EU regulations affecting the dental industry.

We represent our members in dialogue with EU institutions, regulatory bodies, and other associations to ensure that the perspective of dental distributors is heard and respected.

“The strength of our sector lies in knowledge, collaboration, and proactive engagement with regulators.”

— ADDE Executive Committee

Guidance, Position Papers, and External Links

ADDE Publications

“MDR for Dental Distributors: Practical Guidelines”

“Understanding the Role of EUDAMED in the Dental Supply Chain”

Position Papers

ADDE Statement on MDR Implementation Challenges

Joint ADDE–FIDE Workshop Summary: Harmonising Distributor Responsibilities

External Resources

European Commission – MDR Overview

MDCG Guidance Documents

EUDAMED Database Portal

ADDE provides educational and reference materials to support its members and the broader dental industry in understanding and implementing EU regulations.

Stay Informed. Stay Compliant. Stay Connected.

Through ongoing dialogue with European authorities and national associations, ADDE helps shape the regulatory environment that defines our industry’s future.

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