TÜV SÜD Denmark has secured the authority to handle all device codes, excluding the reprocessing sector, in accordance with the EU Medical Device Regulation (MDR) 2017/745, thereby significantly expanding the scope of support for entry into the European medical device market.

TÜV SÜD announced on the 22nd that its Danish subsidiary, TÜV SÜD Danmark ApS, has received official approval from the Danish Medicines Agency (DKMA) for the expansion of the MDR 2017/745 designation scope. Accordingly, the certification body 'NB 2443' is now able to provide evaluation and certification services for virtually all MDR device fields, excluding codes related to reprocessing.

NB 2443 is an independent entity under the TÜV SÜD Medical & Health Services (MHS) business unit, headquartered in Copenhagen, Denmark.

It is responsible for certification in the fields of safety, security, and market accessibility for medical devices and in vitro diagnostic (IVD) devices.

At the time of its initial designation in April 2024, it specialized in cardiology, neurology, orthopedics, and software-based medical device conformity assessment.

With this expansion, in addition to existing fields, products related to in vitro fertilization (IVF), products related to ionizing and non-ionizing radiation, wound and skin care products, ophthalmic and dental products, cleaning, disinfecting, and rinsing equipment, and products for non-medical purposes under MDR 2017/745 have been added.

TÜV SÜD explained that it maintains an average processing time of less than six months from application to certificate issuance for Class IIa, IIb, and III medical devices.

Andreas Stange, Vice President of TÜV SÜD MHS, said, “With the expansion of the DKMA’s designation scope, the European medical device industry has secured a strategic advantage to maintain and strengthen its competitiveness,” adding, “The goal is to transform regulatory requirements into a predictable certification process.”

Martin Jakobsson, Vice President of TÜV SÜD Denmark MHS, stated, “NB 2443 predicts the pricing structure and the entire MDR 2017/745 conformity assessment process "It provides possibilities and transparency," they stated.

TÜV SÜD's MHS business unit stated that more than 1,100 experts at over 30 locations worldwide are currently supporting medical device manufacturers in safety, quality, and market entry.