Regulation (UE) 2017/745 concerning medical devices 

 

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices (hereinafter, the "MDR") repealing Directive 90/385/EEC (hereinafter, the "AIMDD") and Directive 93/42/EEC (hereinafter, the "MDD"), entered into force on 25 May 2017 and applies from 26 May 2021.

The MDR lays down rules concerning the placing on the market, making available on the market or putting into service of the following Devices:

  • Medical devices for human use and their accessories

and

  • Products that are not intended for medical use listed in Annex XVI of the MDR.

 

The Devices are divided into classes I, IIA, IIB, III according to their intended use and inherent risks; that classification is carried out by the Manufacturer in accordance with Annex VIII of the MDR.

Before placing on the market or putting in service a Device, the Manufacturer shall undertake an assessment of the conformity of that Device, in accordance with the applicable procedures set out in Annexes IX to XI of the MDR.

Below there is a brief description of these procedures:



MDR Annex MDR conformity assessment procedure    
Annex IX Annex IX chapter II Assessment of the Device technical documentation EU technical documentation assessment certificate Annex II.4
Annex IX chapters I and III Assessment of the complete quality management system applied to all phases, with verification of the technical documentation of the Devices covered by this system EU quality management system certificate Annex II except 4
Annex X

Assessment of the technical documentation of the Type

and

Performance of tests on a representative example of a given production

 EU type-examination certificate Annex III
Annex XI - part A Assessment of the quality system applied to the manufacturing phase, including verification of the technical documentation of the Devices covered by this system EU quality assurance certificate Annex V
Annex XI - part B

Assessment of the technical documentation of the Device

and

Performance of tests on each individual product

 EU product verification certificate Annex IV (verification of each Device)

 

For devices of classes I sterile (IS) and/or with measuring function (IM) or Reusable Surgical Instruments (IR), IIa, IIb and III, the conformity assessment procedure requires the intervention of a Notified Body, chosen by the Manufacturer.

 

IMQ as Notified Body

IMQ S.p.A is Notified Body for the Regulation (EU) 2017/745 (MDR) with designation obtained on July 19, 2019 and publication of the notification in the NANDO system on August 20, 2019.

The list of Devices and the relevant conformity assessment procedures for which IMQ operates is available on the  NANDO system.

The assessment process applied by IMQ S.p.A is described in the “Regulation for conformity assessment of medical devices pursuant to Regulation (EU) 2017/745 for which IMQ operates as Notified Body No. 0051".

In addition, IMQ S.p.A. has prepared the following guidelines that you can download by filling out the relevant form (link):

  • “Guideline for submission of the technical documentation according to the Regulation (EU) 2017/745 (MDR)”
  • “Guideline for technical documentation according to the Regulation (EU) 2017/745 (MDR): Justification for the application of Article 61 (10) of the MDR”
     

For further information and/or to request a personalized offer from IMQ S.p.A, please contact us by filling in the "Contact Us" form or by writing to medicali@imq.it

 

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