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Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body

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Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body

Please complete the form below and submit to enter your pre-application for MDR 2017/745 certification.

MDCG 2019-14 document

Please provide the name and contact information of the person to whom all correspondence should be addressed

Your name

Company

Job title

Country

State

Address

City

Postal code

Telephone

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?

Please confirm, by check the box, that the device(s) and any accessories covered by this application are classified as medical devices or accessories to medical devices in accordance with the definition provided in Article 2 of the MDR 2017/745.

As a reminder, a ‘Medical Device’ refers to any instrument, apparatus, appliance, software, implant, reagent, material, or other article, including accessories, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

This excludes products that achieve their principal intended action by pharmacological, immunological or metabolic means, in or on the human body, although such means may assist the device in its function.

The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection, or sterilisation of devices referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Confirmed

Does the device contain or has been manufactured utilizing non-viable tissues or cells of human origin, or their derivatives (excluding blood derivatives)?

Yes

Does the device contain a substance which, if used separately, would be considered to be a medicinal product (including herbal medicinal products)?

Yes

Does the device contain material derived from an animal origin. e.g. tallow used as a manufacturing aide?

Yes

Types of devices: Please select all applicable MDR code(s) covering your product(s) as part of this applications from the check list below. *Required

Active implantable devices

MDA 0101 Active implantable devices for stimulation / inhibition / monitoring

MDA 0102 Active implantable devices delivering drugs or other substances

MDA 0103 Active implantable devices supporting or replacing organ functions

MDA 0104 Active implantable devices utilising radiation and other active implantable devices

Active non-implantable devices for imaging, monitoring and / or diagnosis

MDA 0201 Active non-implantable imaging devices utilising ionizing radiation

MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation

MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters

MDA 0204 Other active non-implantable devices for monitoring and / or diagnosis

Active non-implantable therapeutic devices and general active non-implantable devices

MDA 0301 Active non-implantable devices utilising ionizing radiation

MDA 0302 Active non-implantable devices utilising non-ionizing radiation

MDA 0303 Active non-implantable devices utilising hyperthermia / hypothermia

MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy)

MDA 0305 Active non-implantable devices for stimulation or inhibition

MDA 0306 Active non-implantable devices for extra-corporal circulation administration or removal of substances and haemapheresis

MDA 0307 Active non-implantable respiratory devices

MDA 0308 Active non-implantable devices for wound and skin care

MDA 0309 Active non-implantable ophthalmologic devices Aspiration pump for opthalmological use

MDA 0310 Active non-implantable devices for ear nose and throat

MDA 0311 Active non-implantable dental devices

MDA 0312 Other active non-implantable surgical devices

MDA 0313 Active non-implantable prostheses devices for rehabilitation and devices for patient positioning and transport

MDA 0314 Active non-implantable devices for processing and preservation of human cells tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDA 0315 Software

MDA 0316 Medical gas supply systems and parts thereof

MDA 0317 Active non-implantable devices for cleaning disinfection and sterilization

MDA 0318 Other active non-implantable devices

Non-active non-implantable devices

MDN 1101 - Non-active cardiovascular, vascular and neurovascular implants

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 1201 Non-active non-implantable devices for anaesthesia emergency and intensive care

MDN 1202 Non-active non-implantable devices for administration channeling and removal of substances including devices for dialysis

MDN 1203 Non-active non-implantable guide catheters balloon catheters guidewires introducers filters and related tools

MDN 1204 Non-active non-implantable devices for wound and skin care

MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices Orthoses

MDN 1206 Non-active non-implantable ophthalmologic devices

MDN 1207 Non-active non-implantable diagnostic devices

MDN 1208 Non-active non-implantable instruments

MDN 1209 Non-active non-implantable dental materials

MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases

MDN 1211 Non-active non-implantable devices for disinfecting cleaning and rinsing

MDN 1212 Non-active non-implantable devices for processing and preservation of human cells tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

MDN 1214 General non-active non-implantable devices used in health care and other nonactive non-implantable devices

Devices with specific characteristics

MDS 1001 Devices incorporating medicinal substances

MDS 1002 Devices manufactured utilising tissues or cells of human origin or their derivatives

MDS 1003 Devices manufactured utilising tissues or cells of animal origin or their derivatives

MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council

MDS 1005 Devices in sterile condition

MDS 1006 Reusable surgical instruments

MDS 1007 Devices incorporating or consisting of nanomaterial

MDS 1008 Devices utilising biologically active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body

MDS 1009 Devices incorporating software / utilising software / controlled by software including devices intended for controlling monitoring or directly influencing the performance of active or active implantable devices

MDS 1010 Devices with a measuring function

MDS 1011 Devices in systems or procedure

MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

MDS 1013 Class III custom-made implantable devices

MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device

Risk classification

I(s)

I(m)

I(r)

IIa

IIb

IIb Implantable

III

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

Yes

No - Include estimated date when technical file will be ready to be submitted for assessment

If no, include date:

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

Yes

If no, include date:

Form Version 2024-10-28