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




Basic Company Information

Confirm that the device(s) covered by this application is/are a medical device according to the definition in Article 2, (1) of 2017/745 MDR, ‘Medical Device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article 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, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. 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 as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

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

Form Version 2023-03-23