Regulation (UE) 2017/745 concerning medical devices 

IMQ is Notified Body for the new Medical Device Regulation (MDR). IMQ has been designated by the Italian Ministry of Health and Ministry of Economic Development on July 19, 2019. On August 20, the notification has been published in NANDO, the European Commission database.

The list of Devices for which IMQ operates is available in the NANDO system.

The procedures carried out by IMQ and the related evaluation iter are described in the “Regulation for conformity assessment of medical devices pursuant to Regulation (EU) No. 2017/745 for which IMQ operates as Notified Body No. 0051 ".

To request a personalized offer from IMQ, we invite you to fill in the Information Form and send it to medicali@imq.it.

Regulation (EU) No. 2017/745 in short

Regulation (EU) No. 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 will be applied from 26 May 2020.
 
The MDR regulates:

  • Medical devices for human use and their accessories (ref. art. 1, p.1 of the MDR);
  • Device not placed on the market but used in the context of a commercial activity to provide a diagnostic or therapeutic service through information society services or other means of communication (ref. art. 6 of the MDR);
  • Products that are not intended for medical use and listed in Annex XVI (ref. art. 1, p. 2 and Annex XVI of the MDR)

From 27/05/2024, only medical devices conforming to the MDR with a valid EU certificate of conformity issued in accordance with the MDR may be placed on the market.

Classification of devices and conformity assessment procedures

The Devices are divided into 4 risk classes I, IIA, IIB, III according to their intended use and the risks involved.

The classification is carried out by the Manufacturer according to the criteria of Annex VIII of the MDR (ref. art. 51 of the MDR).
 
Before placing a Device on the market or in service, Manufacturer assess the conformity of the Device in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI (ref. art. 52 of the MDR).

The conformity assessment procedures applicable to each class of risk are set out below.

Device Class Conformity assessment procedure (MDR Annexes) Intervention of the Notified Body
I (non-sterile, without measuring function, nonreusable surgical instrument) Declaration of conformity (Annex IV) Not required
I sterile (IS)
I with measurement function (IM)
I Reusable surgical instrument (IR)
- Annex IX - chapter I
or
- Annex XI - part A
Yes, the intervention of the NotifiedBody is limited respectively to:- aspects relating to establishing, securing and maintaining sterile conditions;- aspects relating to the conformity of the Device with the metrological requirements;- aspects relating to the reuse of the Device (cleaning, disinfection, sterilisation, maintenance and functional testing and the related instructions for use).
IIa - Annex IX - chapter I
or
- Annex XI - Part A
or
- Annex XI - Part B
Yes
IIb (non-implantable) - Annexo IX - chapter I
or
- Annex X combined with Annex XI - Part A
or
- Annex X combined with Annex XI - Part B
Yes
IIb implantable *
III

* Annex IX - Chapter II does not apply to the following implantable Devices: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors.

- Annex IX chapter II combined with Annex IX - chapter I
or
- Annex X combined with Annex XI - Part A
or
- Annex X combined with Annex XI - Part B
Yes

The conformity assessment procedures set out in Annexes IX to XI are:

MDR Annex MDR conformity assessment procedure MDR certificate Corresponding MDD/AIMDD Annex
Annex IX Annex IX chapter II Device design assessment Assessment of the Device technical documentation EU technical documentation assessment certificate Annex II.4
Annex IX chapter I Assessment of the quality system (complete) Assessment of the complete quality system applied to all phases - design, manufacture and final control of the product, with verification of the technical documentation of the Devices covered by this SQ EU quality management system certificate Annex II except 4
Annex X Product assessment Assessment of the technical documentation of the Type and Performance of tests on a representative example of a given production (type verification). EU type-examination certificate Annex III
Annex XI - part A Assessment of the quality system production quality assurance) Assessment of the quality system applied to the manufacturing phase of the product, including verification of the technical documentation of the Devices covered by this QS EU quality assurance certificate Annex V
Annex XI - part B Product assessment (related to production) 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)

 

If the conformity assessment procedure requires the intervention of a Notified Body, the Manufacturer (or its Authorised Representative) submits an Application for Certification to a designated Notified Body of its choice.

 

Key aspects of the new Medical Device Regulation (MDR)

  • It introduces new classification rules and modifies some of the MDD rules, making the classification criteria more stringent (ref. Annex XVIII of the MDR);
  • It has 4 classes of risk: I, IIA, IIB and III (Active implantable medical devices are in Class III);
  • It introduces economic operators (Manufacturer, Authorised Representative, Importer and Distributor) and defines their specific obligations;
  • It introduces the need for the Manufacturer to have financial coverage and a person responsible for compliance;
  •  It strengthens the need for the Manufacturer to have: A risk management system; A post-market surveillance system; A system for reporting incidents;
  • It strengthens the need for the Manufacturer to demonstrate compliance with clinical data;
  • It introduces the drafting of specific documents by the Manufacturer: Safety and clinical performance summary for Class III Devices and Implantable
    Devices, Post-market surveillance report for Class I Devices and Periodic safety update report for Class IIA, IIB and III Devices; Trend reporting; Card for patients with implantable devices;
  • It strengthens the concept of traceability of devices with the creation of the UDI system;
  • It strengthens the use of EUDAMED for the collection of Device information in a single European database;
  •  It eliminates conformity assessment procedures based on product quality assurance (Annex VI of the MDD) and statistical product verification (Annex IV of the MDD with sampling).
Management system certification is the endorsement enjoyed by organisations that have chosen to equip themselves with efficient management systems and suitable skills and structures, aimed at continuous improvement. And the higher the prestige of the awarding body, the higher the value of the guarantee. Equipped with state-of-the-art technology, our laboratories have full capability to put products through all the checks required by the major European directives and international standards. The certifications issued by IMQ are synonymous with trust. They guarantee safety, performance, efficiency and quality standards. More than 10,000 companies have turned to IMQ to certify their products and stand out on the market. Notified body for the main EU directives, IMQ offers tests and CE certifications to assess the conformity of the products to the requirements required to be marketed on the European market. Inspections and audits validate the conformity of electrical installations, equipment, supplies and services with the applicable technical and legislative specifications. IMQ is leader in Europe in the conformity assessment activity, technical partner chosen by Ministries and Authorities for market control purposes. IMQ is a brand recognized by the market as a synonym of safety and quality, and an internationally recognized partner, a valued member of the main international regulatory work groups. All IMQ personnel are required to strictly observe professional secrecy. IMQ has been working for 70 years trying to anticipate the future, to make the present safer.
This site uses cookies to enhance user experience. By using our site you accept the terms of our Cookie policy.