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Regulation EU 2017/745

Regolamento UE 2017/745

Regulation EU 2017/745 on medical devices (Medical Device Regulation, “MDR”) regulates all types of medical devices, including active implantable devices, only excluding in vitro  diagnostics (regulated by Regulation EU 2017/746).

Not only, the MDR also applies to devices with no medical purpose declared or intended by the manufacturer but that are analogous for the application context or due to the fact that they act on the human body (a list of such devices is currently present in one of the Regulation’s annexes, including for instance contact lenses or liposuction equipment, but other devices will be added in time).

The introduction of the MDR has brought in significant transformations in the world of medical device manufacturers.

Why is the MDR so important?

The main goal of the MDR is to ensure a higher level of safety and health protection for patients. This means that all medical devices put on the European market must comply with higher qualitative standards and undergo stricter controls.

Classification of Medical Devices

The MDR defines a very detailed classification system to divide medical devices into different risk categories.

This classification is essential because it determines the conformity assessment procedures and, consequently, the manufacturers’ obligations.

The MDR provides for four main risk classes:

  • Class I: Low risk devices (e.g. patches, thermometers or single-use syringes);
  • Class IIa: Moderate risk devices (e.g. devices for in vitro diagnostics and some surgical tools);
  • Class IIb: Major risk devices (e.g. vascular stents and contact lenses);
  • Class III: High risk devices (e.g. pacemakers and articular prostheses).

How is a medical device classified?

The classification of a medical device is made by the manufacturer based on the criteria indicated in Annex VIII of the MDR. These criteria take into account the following:

  • The intended use provided for by the device: What is the device?
  • The operating principles: How does the device work?
  • The materials used: Which materials are used in the device manufacturing?
  • The effects on the human body: Which are the potential risks for health?

Which are the Conformity Assessment Procedures?

Before marketing or putting into service a device, the manufacturer proceeds to assess the conformity of this device, according to the procedures applicable as per annexes IX to XI of the MDR.

You can find below a brief description of the assessment procedures:

MDR AnnexMDR conformity assessment procedureMDR CertificateCorresponding to the MDD/AIMDD
Annex IXAnnex IX chapter IIAssessment of the device technical documentationEU Technical Documentation Assessment CertificateAnnex II.4
Annex IX chapters I and IIIAssessment of the full quality management system applied to all phases, with the control of the technical documentation of the devices envisaged by this systemEU Quality Management System CertificateAnnex II excluding 4
Annex XAssessment of the technical documentation for the Type and Performance of tests on a representative sample of a given productionEU Type-Examination CertificateAnnex III
Annex XI – part AAssessment of the quality management system applied to the manufacturing phase, with the control of the technical documentation of the devices envisaged by this systemEU Quality Assurance CertificateAnnex V
Annex XI – part BAssessment of the device technical documentation and Performance of tests on each single productEU Product Verification CertificateAnnex IV (verification of each device)

Di Renzo Regulatory Affairs is able to support manufacturers in this delicate transition phase.

Thanks to the expertise of our medical device team, we can offer assistance in all medical device certification and post-market phases, on the documentation preparation, on PMS activities and we can support them in the interfacing with the notified bodies.