Kiwa Cermet Italia, a leading Notified Body with over 20 years of extensive experience in the medical sector and thousands of certified devices, is able to provide all the necessary services to obtain comprehensive answers and reliable information on the Medical Device certification process in accordance with Directive 93/42/EEC.

Thanks to the experience of Kiwa Cermet Italia, companies of the medical sector can demonstrate compliance with the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. Moreover, thanks to the technical expertise of Kiwa Cermet Italia, medical device manufacturers can rely on a trusted partner, able to guarantee the execution of an effective conformity assessment process, which can combine the guarantee of market safeguarding with the business tool.

The role of the Notified Body

Kiwa Italia operates independently, objectively, and impartially in accordance with its bylaws during conformity assessment activities, ensuring high levels of competence, professionalism, and absolute integrity among its professionals, so as not to influence in any way the judgment or results of the CE marking process. Furthermore, Kiwa has internal procedures in place to guarantee the absolute confidentiality of the information received during the assessment activities.

Through its membership in the NB Team (European association of Notified Bodies in the medical devices sector), Kiwa Italia has rapid access to all updated information and new approaches applicable to medical devices. Kiwa Italia actively participates in technical working groups for the development of the main documents and guidelines in the medical device sector.

Entry into force of Regulation (EU) 2023/607, transitional provisions for appropriate surveillance activities under the MDD

On March 15, 2023, Regulation (EU) 2023/607 was published, amending Regulation (EU) 2017/745 regarding transitional provisions for medical devices. This regulation entered into force on March 21, 2023, and extends the validity of certificates issued under Directive 93/42/EEC (MDD) subject to certain conditions, including a commitment to implement a certification process according to Regulation (EU) 2017/745 (MDR).

This activity applies to Medical Devices that constitute Legacy Devices and their accessories. In particular, Medical Devices:

  1. have a certificate issued by a Notified Body in accordance with Directive 93/42/EEC and valid pursuant to Article 120 (2) of the MDR; and
  2. are subject to appropriate surveillance in accordance with the provisions of Article 120 (3 e) of the MDR.

According to recent regulatory changes, Medical Devices that meet the requirements set out in Article 120 of the MDR can benefit from the extension of the transitional period for the application of the MDR provided for in Article 120 (3 a) of the MDR, during which such Medical Devices may be placed on the market or put into service.

The Customer shall submit the request to Kiwa Cermet Italia by using the specific request form.

Kiwa Italia will assess the feasibility of the request and confirm the appropriate surveillance process, according to the conformity assessment procedures pursuant to Article 120 (3 e) of the MDR. The conformity assessment activities for the purpose of appropriate surveillance may include the following:

  1. Scheduled annual surveillance audits;
  2. Unannounced audits;
  3. Evaluations of changes made to Medical Devices and/or the related quality management system that do not have a significant impact on the design and intended use of the MDs, as per Article 120 (3 c) of the MDR;
  4. Additional assessments, including short-notice audits;
  5. Transfer of surveillance from another NB/MDD.

For more detailed information regarding the service offered, terms and conditions, as well as operational procedures, please refer to Regulation RG 01 MED_MDD.

Related services

Kiwa Italia also provides services such as:

  • Certification of Quality Management Systems according to the main reference standards (e.g., ISO 13485, ISO 9001,...) as a Body accredited by ACCREDIA;
  • Laboratory testing such as electrical safety, electromagnetic compatibility and functional tests in compliance with harmonized standards.