Medical Device International - TUV NORD GROUP

In the context of the intense changes in the Regulatory Frameworks concerning the evaluation and circulation of Medical Devices (MDI) at a global level, TUV NORD GROUP's Medical Device International (MDI) has been structured in recent years to provide MDI evaluation and certification services worldwide, with the following individual departments/organizations:

The Notified Body TÜV NORD CERT GmbH (0044) for conformity assessment according to Regulation (EU) 2017/745 Medical Device Regulation (MDR) (https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=315449 );

TNC 0044 is also in the process of assessment for notification according to Regulation (EU) 2017/746 In Vitro Diagnostics Regulation (IVDR).

The Notified Body TÜV NORD POLSKA (2274), for conformity assessment in accordance with Regulation (EU) 2017/745 Medical Device Regulation (MDR) https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=317538

TUV USA Medical, Recognized Certification Body for the Medical Device Single Audit Program -MDSAP (recognized in USA, Canada, Brazil, Australia and Japan)

The TUV UK Medical for UK Conformity Assessment (UKCA Mark). TUV UK Medical, has been assessed by the MHRA in the UK, and is expected to be approved to assess Manufacturers under the UK Regulation for UKCA certificates in 2022.

The Medical Department of TUV HELLAS (TUV NORD) SA.

TUV HELLAS (TUV NORD) SA, started to operate in the MD sector already in 2000, with inspections and certifications for ISO 900x, EN 4600x, and the compliance of companies with the Ministerial Decision E3/833/1999 (today, with DY8/1348/2004).

Subsequently, and on the full implementation of the Directives, and the increasing market requirements, it further developed these activities, and since 2012 it has been accredited as a certification body for EN ISO 13485 by the ESYD.

The application of the standard to activities of design, production, distribution, installation, technical support and services of medical devices, indicates (to a certain extent) compliance with the requirements of EU Regulations and Directives for CE assessment and CE marking.

The latest European version of EN ISO 13485:2016/A11:2021 includes the mapping of requirements of the Standard to the MDR and IVDR Regulations

In recent years, the Medical Department of TÜV HELLAS, has been significantly strengthened with well-established executives with vast experience in the field of I/P.

Notified Bodies TNC 0044 and TNP 2274 approve the team of Auditors/Experts, for the 93/42 Directive and the MDR 2017/745 Regulation, as well as by TUV UK for the UKCA scheme. They participate in Manufacturers' assessments according to the requirements of MDD 93/42/EEC ("legacy" devices) and MDR 745/2017, as well as in MDI Technical Committees for all Medical Device Assessment Schemes.

In view of the evolving changes affecting MDs in the European Union and in several other countries, appropriate training programs and open workshops are being developed to facilitate the dissemination of information and to support organizations (Manufacturers, Importers, Distributors, Users) to better identify the requirements and manage them according to their needs.

Useful Links and Communication:

https://www.tuev-nord.de/en/company/certification/mdr/

https://www.tuev-nord.de/en/company/certification/mdr/further-information-on-mdr/

medicalgreece@tuv-nord.com