Technical Documentation Review by Product Reviewer
7
Site Audit
On-site audit
On-site inspection
8
FINAL REVIEW / CERTIFICATION DECISION
Final review and certification decision
Pre-Application (M.FR.07.01)
Submission of business license
9
CERTIFICATION ISSUE
Certificate issuance
Certificate issuance
European Medical Device Regulation MDR 2017/745
A European Notified Body, a partner of GRC Certification Institute
Notice is in accordance with the European Medical Device Regulation MDR 2017/745,
By conducting a suitability assessment,
Ensures the safety and performance of medical devices,
We provide services that meet our customers' needs.
What is a medical device?
Definition of medical devices (MDR 2017/745)
For human use, alone or in combination, for one or more of the following specific medical purposes:
Means any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer.
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, alleviation or compensation for injury or disability;
Investigation, replacement or modification of anatomical structures or physiological or pathological processes or conditions;
Provides information through in vitro testing of samples derived from the human body, including organ, blood and tissue donations
Although it does not achieve its primary intended action in the human body through pharmacological, immunological or metabolic means,
Something that can assist a function through such means.
Devices for regulating or supporting pregnancy
Products specially designed for the cleaning, disinfection or sterilization of the devices referred to in Article 1 (4) and the devices referred to in the first paragraph of this Article.
Note: The devices mentioned in Article 1(4) are listed in Annex XVI (Products not intended for medical purposes), Accessories for medical devices and medical devices.
Medical Device Regulation (EU) 2017/745
European Medical Device Regulation MDR 2017/745
A regulation established and adopted in 2017 in the European Union (EU) to ensure the safety and performance of medical devices.
It was enacted with the purpose of strengthening the existing medical device directive, MDD 93/42/EEC, by including the following:
Strengthening product safety and performance requirements
Strengthening clinical evaluation and data requirements
