External (contract) resource for Notified Bodies.
REGULATORY AFFAIRS CONSULTING
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Yes, I have an NBOG F 2014-2 that justifies my qualification for these codes
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Directive:
MD 0100 General non-active, non-implantable medical devices
MD 0200 Non-active implants
MD 0400 Non-active dental devices and accessories
Regulation:
MDN 1100 Non-active implants and long term surgically invasive devices
MDN 1200 Non-active non-implantable devices
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Directive:
MD 0103 Non-active orthopaedic and rehabilitation devices
MD 0106 Non-active instruments
MD 0202 Non-active orthopaedic implants
MD 0204 Non-active soft tissue implants
MD 0401 Non-active dental equipment and instruments
MD 0403 Dental implants
Regulation:
MDN 1102 Non-active osteo- and orthopaedic implants
MDN 1103 Non-active dental implants and dental materials
MDN 1104 Non-active soft tissue and other implants
MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
MDN 1208 Non-active non-implantable instruments
MDS 1006 Reusable surgical instruments
MDS 1011 Devices in systems or procedure packs
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MDR Technical Documentation Assessment (any classification), MDD Design Dossiers, MDD Technical File Surveillance, Unannounced audits, QMS audits.
OUR PEOPLE
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years as a technical specialist & scheme manager at BSI.
“I love being at the cutting edge of regulation, and working with Notified Bodies is a great way to do this.”
- Joseph Langley
DEVICES
Large Joints |
Small Joints |
Extremities |
Trauma |
Limb Salvage |
Maxillofacial |
Sports Medicine |
Meniscal Repair |
Reusable Surgical Instruments |
Single Use Instruments |
Large Joints | Small Joints | Extremities | Trauma | Limb Salvage | Maxillofacial | Sports Medicine | Meniscal Repair | Reusable Surgical Instruments | Single Use Instruments |
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Page last updated: July 2026.