Thanks to the experience of Kiwa Notified Bodies, 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 Medical, 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.

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:

I. 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

II. 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 Medical through medical@kiwa.com or directly to Kiwa Notified Bodies.

Kiwa Notified Bodies 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.