3.2 Safe, high-quality products

certifications

The majority of HARTMANN products are certified according to the new EU Medical Device Regulation 2017/745. In addition, the majority of the Group’s locations hold ISO 9001 or ISO 13485 certifications for their Quality Management Systems – and many locations are certified to both standards.

Regulatory Affairs

The Regulatory Affairs Department has given high priority to implementing the regulatory requirements of the MDR. In general, this Department monitors the standards and guidelines particularly relevant to HARTMANN.

In 2021 a focus of the Department was on implementing conformity assessment procedures and the associated management of technical documentation. Furthermore, the Department additionally focused on the challenges facing HARTMANN arising from the UK’s withdrawal from the EU (“Brexit”).

product safety

The HARTMANN Group’s medical product portfolio includes Class 1 products (no or very low risk to patients), 2a (medium risk) and 2b (medium to high risk). For all Class 1 products, the implementation of the Medical Device Regulation (MDR) has already been completed.

complaints

HARTMANN has set out in binding guidelines the core procedure for product complaints and the measures to be taken in the event of any incident. The Company always regards complaints as an opportunity for quality improvements and to strengthen its customer relationships through competent and timely processing. Measured by sales figures, HARTMANN recorded a very low number of complaints in the reporting period.