Medical devices
What are medical devices?
Medical devices are defined as, for example, instruments, devices, equipment, software, implants or other items intended by the manufacturer to be used, alone or in combination, in humans for one or more of a number of specific therapeutic purposes.
The most common use
Who is this service particularly suitable for?
Manufacturers of medical devices
Importers of medical devices
Hospitals, pharmacies
Typical services
In the field of medical devices, our office most often provides the following services:
advice and representation in the marketing of a medical device (registration, notification, conformity assessment) and in the system of reimbursement from public health insurance
advice and representation in proceedings before administrative authorities and administrative courts
preparation of model contract documents (distribution chain, quality agreement, etc.), revision of contracts
public procurement consultancy
Advice and representation in negotiations with the notified body (certification of medical devices, audits, contracts)
implementation of EU medical device legislation (MDR, IVDR)
Analysis and strategies for obtaining health insurance reimbursement for health care voucher
resources (ZP Voucher) and medical supplies (ZUM)