Pre-application form for UK MDR 2002 certification at Intertek Medical Notified Body

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What other certification services are you interested in?

ISO 13485 EN ISO 13485

MDSAP

UK MDR 2002

Other services provided by Intertek

If other, please specify...

Basic Company Information

Are you a current Intertek client?

If yes, please specify for what services

Specify number of sites (manufacturing site, head office, etc.) as part of this application.

How many Full Time Equivalent (FTE) employees will be involved, at ALL sites?

MD Code - Description

Non-Active Medical Devices

General non-active, non-implantable medical devices

General non-active, non-implantable medical devices

MD 0101 - Non-active devices for anaesthesia, emergency and intensive care

MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis

MD 0103 - Non-active othopaedic and rehabilitation devices

MD 0104 - Non-active medical devices with measuring function

MD 0105 - Non-active opthalmologic devices

MD 0106 - Non-active instruments

MD 0107 - Contraceptive medical devices

MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing

MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assissted reproductive technologies (ART)

Non-active implants

Non-active implants

MD 0201 - Non-active cardiovascular implants

MD 0202 - Non-active orthopaedic implants

MD 0203 - Non-active functional implants

MD 0204 - Non-active soft tissue implants

Non-active devices for wound care

Non-active devices for wound care

MD 0301 - Bandages and wound dressings

MD 0302 - Suture material and clamps

MD 0303 - Other medical devices for wound care

Non-active dental devices and accessories

Non-active dental devices and accessories

MD 0401 - Non-active dental equipment and instruments

MD 0402 - Dental materials

MD 0403 - Dental implants

Active Medical Devices

General active medical devices

Active Devices for imaging

Active Devices for imaging

MD 1201 - Imaging devices utilizing ionizing rays

MD 1202 - Imaging devices utilizing non-ionizing rays

Active Monitoring devices

Active Monitoring devices

MD 1301 - Monitoring devices of non-vital physiological parameters

MD 1302 - Monitoring devices of vital physiological parameters

Active Devices for radiation therapy and thermo therapy

Active Devices for radiation therapy and thermo therapy

MD 1401 - Devices utilising ionizing radiation

MD 1402 - Devices utilizing non-ionizing radiation

MD 1403 - Devices for hyperthermia/hypothermia

MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)

MDS Code - Description

MDS Codes

MDS 7001 - Devices containing medicinal substances

MDS 7002 - Devices derived from\made from animal tissue

MDS 7003 - Devices with derivatives of human blood

MDS 7004 - Machinery

Sterilization methods for medical devices

Readiness - Are the technical documentation files ready to be reviewed?

If no, include date:

Does your quality management system (QMS) meet the requirements of MDR?

If no, include date: