Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more, intended to be used in or on humans for medical purposes, performing their main action through means other than pharmacological, immunological or metabolic. To be placed on the market, devices must comply with applicable legislation and be CE marked.
On July 14, 2021, Kiwa Cermet Italia, has been designated for Regulation (EU) 2017/745 by the Italian Ministry of Health with publication in NANDO on 14/07/2021. The authorization 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 the Directive 90/385/EEC on Active Implantable Medical Devices (AIMD), to regulate the 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 subsequently 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 be placed on the European market.
Medical companies are therefore challenged to address the changes and requirements that the MDR has introduced, planning and implementing strategies in good time to ensure their devices comply with the new requirements.
Key changes include:
- greater emphasis on a life-cycle approach to safety, supported by clinical data (Art. 61)
- new rules for classification of devices with more rigorous and precise criteria (Annex VIII);
- new economic operators (agent, importer and distributor) for which specific obligations are defined (arts. 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 a summary of 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 system of unique identification of devices (UDI, art.27) for the traceability and effectiveness of activities related to post-marketing safety 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 with Competent Authorities for medical devices based on substances, drugs and animal tissues and introduction of a new clinical evaluation consultation for some 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 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 high number of experts in different countries, Kiwa Cermet Italia is able to deliver the assessment activities at a global level.
Kiwa Cermet Italia operates by statute in an independent, objective and impartial way during conformity assessment activities, ensuring high levels of competence, professionalism and absolute integrity of its experts, so as not to influence in any way the judgment or the results of the EU certification process. Furthermore, Kiwa has internal procedures in place to ensure absolute confidentiality of information received during the assessment activities.
Through the association to Team NB (European Association of Notified Bodies in the field of medical devices), Kiwa Cermet Italia actively participates in the technical working tables for the development of the main documents and guidelines of the medical sector and has quick access to all updated information and new approaches applicable to medical devices.
Procedure for EU Certifications of Conformity
The procedure to be followed to obtain the EU Conformity Certificate differs based on the risk class of the medical device according to art. 52 of the MDR.
For Class I sterile devices (Is) or with measurement function (Im) or reusable surgical instruments (Ir), IIa, IIb and III (including custom implantables), the intervention of the Notified Body is always required.
Once the manufacturer has chosen the certification procedure, will have to submit the request to Kiwa Italia using the specific form and sending it to email@example.com
The activities that Kiwa Cermet Italia can carry out for the conformity assessment are defined and described in REG01 MED MDR Regulation.
Kiwa Cermet Italia's standard rates for conformity assessment activities are as follows:
€ 380 per hour
Clinical data assessment (including
PMCF, PSUR, SSCP)*
€ 400 per hour
€ 270 per hour
€ 320 per hour
*Also applicable to requests for extension, modification, and supplemental activities.