Conformity Assessment of Medical Devices in accordance with the MDR is aimed at manufacturers and producers of medical devices, i.e., a heterogeneous category of products, such as active equipment, orthopedic implants, reusable instruments, substances and materials, software, and more, intended to be used in or on humans for medical purposes, carrying out their principal action through means other than pharmacological, immunological, or metabolic. In order to be placed on the market, devices must comply with applicable legislation and bear the CE marking.

Kiwa Cermet Italia, on July 14, 2021 was designated for Regulation (EU) 2017/745 by the Italian Ministry of Health with publication in NANDO on 14/07/2021. The authorization granted covers most of the product categories and technologies, ensuring not only continuity of market access for our customers but also integrating other devices and technologies that were not included in the previous designation according to Directive 93/42/EEC, (the specific list of codes and devices can be found on the NANDO website.

The Regulation (EU) 2017/745 - MDR

The Medical Device Regulation (EU) 2017/745 (MDR) replaced the current Directive 93/42/EEC (MDD) and also Directive 90/385/EEC on Active Implantable Medical Devices (AIMD) to regulate new conditions for placing Medical Devices on the market with the aim of ensuring the safety and health protection of patients and users.

The MDR was officially published on May 5, 2017, and entered into force on May 25, 2017, but as later established by Regulation (EU) 2020/561, it found its full application on May 26, 2021.

In accordance with Article 120.3 of the MDR and the subsequent corrigendum, medical devices that possess a valid CE certificate in accordance with the MDD and AIMD Directives and Class I medical devices that are up-classified by the MDR and possess a valid Declaration of Conformity may continue to be placed on the market until May 26, 2024 and put into service until May 26, 2025.

By May 27, 2024, all medical devices must be MDR-compliant in order to circulate in Europe.

Medical device companies are therefore challenged to deal with the many changes and requirements that the MDR has introduced, planning and implementing strategies in good time to ensure that their devices comply with the new requirements.

Key changes include:

  • greater emphasis for a life-cycle approach to safety, supported by clinical data (Art. 61);
    new device classification rules with more stringent and timely criteria (Annex VIII);
  • new economic operators (authorised representative, importer and distributor) for whom specific obligations are defined (Art. 11, 13 and 14);
  • need for financial coverage (Art. 10) and a person responsible for compliance (Art. 15) for the manufacturer;
  • drafting of specific documents such as summary regarding safety and clinical performance
  • (SSCP, Art. 32) for implantable and class III devices; periodic safety update report
  • (PSUR, Art. 86) for class IIa, IIb and III devices; and finally the card for patients with implantable devices (Art. 18);
  • inclusion of products that do not have a medical purpose such as products with aesthetic purposes (Annex XVI);
  • new unique device identification system (UDI, Art. 27) for traceability and effectiveness of post-market safety activities and new European Database (EUDAMED, Art. 33) that will play a central role in increasing both the quantity, quality and availability of data;
  • strengthening of external consultation procedures at Competent Authorities for medical devices based on animal substances, drugs, and tissues, and introduction of a new clinical evaluation consultation for certain Class IIb, implantable, and Class III devices by a group of independent experts appointed by the European Commission (Art. 54);

The Role of Kiwa

Kiwa Cermet Italia S.p.A., as a Notified Body (NB 0476) performs conformity assessment activities for the issuance of EU certification in accordance with Regulation (EU) 2017/745 (MDR). Moreover, thanks to the presence of a large number of professionals in different countries, Kiwa Cermet Italia is able to deliver the assessment activities globally.

Kiwa Cermet Italia operates by statute in an independent, objective and impartial manner during conformity assessment activities, ensuring high levels of competence, professionalism and absolute integrity of its professionals, such that they do not influence in any way the judgment or results of the EU certification process. In addition, Kiwa has internal procedures useful for ensuring the absolute confidentiality of information received during the performance of assessment activities.

Through its association with Team NB (European Association of Notified Bodies in Medical Devices), Kiwa Cermet Italia actively participates in the technical working tables for the development of the main documents and guidelines in the medical sector and has quick access to all updated information and new approaches applicable to medical devices.

Iter for EU Certificates of Conformity

The process for obtaining EU Certificate of Conformity differs based on the risk class of the medical device according to Article 52 of the MDR.

For Class I sterile (Is) or measuring-function (Im) devices or reusable surgical instruments (Ir), IIa, IIb, and III (including custom implantables), Notified Body involvement is always required.

The manufacturer, once the certification process has been chosen, must submit the request to Kiwa Italia using the specific form and sending it to medical@kiwa.com.

The activities that Kiwa Cermet Italia can conduct for conformity assessment are defined and described in REG01 MED MDR.

Rates

Kiwa Cermet Italia's standard fees for conformity assessment activities are as follows:

Evaluation of the documentation*

€ 380/h

Evaluation of clinical data (including PMCF/PSUR/SSCP)*

€ 400/h

Audit*

€ 270/h

Unannounced audits

€ 320/h

*Applicable also to requests for extension, modification and supplementary activities.