Ente Certificazione Macchine is Notified Body No. 1282 for the European Medical Devices Regulation 2017/745 (MDR), designated by the Italian Ministry of Health, with publication of the notification on the European Commission’s NANDO portal on 14 October 2022.
The list of accreditations and devices falling within the scope of ECM can be consulted on the European Commission’s Nando Information System.
View the ECM price list of conformity activities under MDR.
See the Regulations for Medical Device Certification (MDR).
THE REGULATION (EU) 2017/745
Regulation (EU) 2017/745 (MDR), which replaces Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD), entered into force on 25 May 2017. After a transition period, as of 26 May 2021 the MDR applies to all manufacturers wishing to place their medical devices on the EU market.
As of 27 May 2024, the MDR will be fully applicable to all medical devices, which can only be placed on the market with a valid EU certificate issued under the MDR.
Regulation (EU) 2017/745 imposes stringent compliance requirements aimed to ensure high standards of quality and safety and includes some significant differences from previous directives, including:
- Extension of scope and new classification criteria (to also include devices that do not have an intended medical purpose);
- Definition of economic operators and related duties;
- The manufacturer must establish a Person Responsible for Compliance (PRRC);
- New rules on traceability (UDI) and registration of medical devices (Eudamed);
- Stricter and more precise requirements regarding technical documentation and clinical evaluations and investigations;
- Increased post-market surveillance and follow-up obligations.
CLASSIFICATION AND CONFORMITY ASSESSMENT PROCEDURE
Medical devices are divided into 4 classes depending on their intended use and the risk they involve:
- Class I devices (low/medium risk), including Is – sterile, Im – measuring, IR – reusable;
- Class IIa devices (medium risk)
- Class IIb devices (medium/high risk)
- Class III devices (high risk).
Classification is carried out by the Manufacturer according to the criteria of Annex VIII of the MDR.
Class I devices, excluding Is, Im and IR, do not require the intervention of the Notified Body and can be self-certified by the manufacturer. For all other risk classes (Is, Im, IR, IIa, IIb and III), the intervention of the Notified Body is required.
The procedure for obtaining the EU Certificate differs depending on the risk class of the device.
THE ECM SERVICES
ECM Medical Devices Division is a team of experts in testing, regulatory assessment and quality auditing, able to provide certification services according to the MDR Regulation.
Operating as Notified Body No. 1282, Ente Certificazione Macchine provides medical device manufacturers with a conformity assessment service for EU certification according to Regulation (EU) 2017/745. The EU Certification process consists of several steps:
- Review of technical documentation (including clinical evaluation) and Management System documentation;
- Onsite Audit to verify the Management System processes;
- Final review of all the evidence collected for the verification of the requirements of the Regulation;
- Issue of the EU Certificate.
In addition, ECM provides the medical device market with the following services:
- Quality Management System Audit and Certification according to the ISO 13485 standard;
- Testing services as an ISO 17025 accredited Testing Laboratory.
REQUEST AN OFFER
To request a quotation, you can download and fill out the form Preliminary Data collection for medical device certification – MDR 2017/745 and see the document Description and submission of the medical device certification application – MDR 2017/745.
To submit the completed“Preliminary Data collection form for medical device certification – MDR 2017/745” and to request any information about our services for the medical device sector, you can contact our offices at info@entecerma.it or reach out to our Sales Division: Diego Stevanella – diego.s@entecerma.it and Marzia Pellegrini – marzia.p@entecerma.it.