<small>CE MARKING OF MEDICAL DEVICES</small>REG. 2017/745  (MDR)

CE MARKING OF MEDICAL DEVICESREG. 2017/745 (MDR)

Who is concerned?

All the companies manufacturing medical devices

CONTEXT

The Regulation 2017/745 lays down rules concerning the placing on the market of Medical Devices, aiming at ensuring the safety and protection of the health of patients, users and other persons when using such products.

Medical Devices are a wide range of products (instruments, apparatus, implants, substances, software or other) intended to be used in or on human beings for diagnosis, prevention, monitoring or treatment, alleviation of or compensation for injuries or disabilities, but also for investigation, replacement or modification of the anatomy or of a physiological process or for the control of conception. The Medical Device does not achieve its principal intended action by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (ancillary action).

The intended use of the product shall be characterized as a medical purpose.

BENEFITS

SERVICES

Certiquality, acting as Notified Body (no. 0546) for the Regulation 2017/745, carries out the evaluations for certification for ce marking of medical devices according to the product categories listed on the NANDO portal


PUBLIC PROCEDURE FOR THE APPLICATION

SERVICES

CERTIFICATION PROCEDURE

  • The Manufacturer submits a certification application to Certiquality (Notified Body);
  • Certiquality checks the technical and clinical documentation of the medical device prepared by the Manufacturer;
  • Certiquality audits the offices and production sites of the Manufacturer and, where needed, the premises of its critical suppliers;
  • If the evaluations are successful, Certiquality issues the certificate for CE marking of medical device, with a period of validity of five years.
  • In the period of validity of the certificate, Certiquality carries out annual surveillance audits.

INSIGHT

PLACING ON THE MARKET OF THE MEDICAL DEVICE

For the purposes of a correct placement on the market of the Medical Device, it is the Manufacturer responsibility to:

  • Classify the Medical Device.  Classification is based on the intended use of the product. The Regulation 2017/745 sets out that Medical Devices can be divided into four classes: I, IIa, IIb and III, depending on their complexity and the potential risk for patients, users or other persons.
  • Demonstrate the compliance of the Medical Device with the Requirements of the Regulation 745/2017.  To demonstrate the product conformity with the General Safety and Performance Requirements, the Manufacturer shall prepare appropriate technical and clinical documentation, describing the Medical Device and the related design, manufacture, marketing and post-market surveillance processes.
  • To guarantee and CE mark the Medical Device. The statement of conformity of the Medical Device is carried out by the Manufacturer, by issuing the Declaration of Conformity.
  • For Medical Devices having a class higher than I and for some aspects concerning class I devices (sterile, with measuring function or re-usable devices), the Manufacturer, before attest product conformity, shall start an assessment procedure of the conformity of the Device with the support of an independent third party, the Notified Body.

TECHNICAL DOCUMENTATION OF THE MEDICAL DEVICE

The Technical documentation of the Medical Device consists of all the documents prepared by the  Manufacturer, regardless of any partial or total outsourcing of the design and/or production, to demonstrate the compliance of the Medical Device with the requirements of the Regulation 2017/745. The technical documentation also includes the clinical documentation for demonstrating the efficacy and safety of the medical device.

TRAINING

Certiquality provides courses that cover various subjects, such as:

  • the Regulation (EU) 2017/745 of 5 April 2017;
  • the person responsible for the implementation of the Regulation (EU) 2017/745;
  • the management of risks in the manufacture of medical devices in accordance with the ISO 14971 standard;
  • the ISO 13485 standard (Quality system for medical devices);
  • the design and validation of a substance-based medical device.


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