top of page

Medical Device Regulation 2017/745

MRI 스캔

Medical Device

MDR 2017/745

MDR Certification Process

의사의 방문

1

Communication

Product Information

  • ​Provisional estimate

2

Pre-Application

Quotation and Agreement

  • Pre-Application (M.FR.07.01)

  • Submission of business license​

3

Application

APPLICATION REVIEW

  • Application review

  • Confirmation of the application and information

  • Application Review (M.FR.35.21)

4

Stage 1 Audit

Performing Stage1 audit

  • MDR Conformity assessment

  • Technical File

5

CER/PMS Review

CER and PMS

  • Review of CER and PMS by Clinical Specialist

6

TCF Review

Technical File Reivew

  • ​Review of TCF by Product Reviewer

7

Site Audit

Site Audit

  • Conduct Site Audit​

8

FINAL REVIEW / CERTIFICATION DECISION

Final Review / Decision

  • ​Final Review of Technical Files and On-site Audit

  • Decisio on NB Certification

9

CERTIFICATION ISSUE

CE Certificate

  • Issurance of Certificate

Medical Device Regulation (EU) 2017/745

Notice, the partner of GRC Certification, conducts

conformity assessment audits as a European Notified Body.

 

in accordance with the European Medical Device Regulation

(MDR) 2017/745.

We ensure the safety and performance of medical devices

and provide services that meet customer requirements.

NOTICE_로고.png
pngwing.com (2).png

What is Medical Device?

Definition of Medical Device (MDR 2017/745)

‘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.

Medical Device Regulation (EU) 2017/745

MDR 2017/745

The regulation adopted by European Union (EU) in 2017 to ensure the safety and eprformance of medical devices was established to strengthen the following aspects of the existing Medical Device Directive (MDD) 93/42/EEC:

  • Enhanced product safety and performance requirements

  • Strengthened clinical evaluation and data requirements

  • Increased traceability and transparency

  • Enhanced post-market surveillance

  • Increased regulatory compliance responsibility

  • Expanded definition and scope of medical devices

General Safety and Performance Requirement

MDR 2017/745 Annex I

Requirements that must be met before a medical device is placed on the market :

  • Chapter I : General requirements

  • Chapter II : Requirements regarding design and manufacture

  • Chapter III : Requirements regarding the information supplied with the device

Classification

Medical device classification

  • Class I : Devices with low risk, such as products that support the patient externally

  • Class Is/Im/Ir : Sterile, measruing, and reusable Class I devices

  • Class IIa/IIb : Devices with moderate risk, such as electrical medical devices

  • Class III : Devices with high risk, such as cardiovascular catheters

MDA/MDN/MDS/MDT Code

Classify medical devices based on their characteristics

  • MDA 0100   Active implantable devices

  • MDA 0200   Active non-implantable devices for imaging, monitoring and/or diagnosis

  • MDA 0300   Active non-implantable therapeutic devices and general active non-implantable devices

  • MDN 1100   Non-active implants and long term surgically invasive devices

  • MDN 1200   Non-active non-implantable device

  • MDS 1000   Devices with specific characteristics

  • MDT 2000   Devices for which specific technologies or processes are used

bottom of page