What’s that?
MDR stands for the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, which will enter into force on 26 May 2020.
What’s changing?
The MDR is directly applicable in all EU Member States, including the Czech Republic, as a regulation of the European Union and from the above date it applies in priority to the existing Act No. 268/2014 Coll., on medical devices.
The MDR and its related regulations and ISO standards bring, for example, new requirements for risk management systems, technical documentation and clinical trials of medical devices. It also introduces the so-called Unique Device Identification (UDI) system, which also entails new administrative and registration obligations.
What can we help you with?
In connection with the MDR, our office advises manufacturers, distributors or other participants in the medical device business chain on all phases of their operations.
By nature, our advice mostly concerns Class I medical devices that are not subject to certification and for which the manufacturers otherwise have to deal with all the formalities arising from the legislation themselves. However, we also provide services relating to other classes of medical devices, for example in disputes between manufacturers and notified bodies.
As part of the MDR implementation, we are able to guide you through the entire process and advise you on individual sub-problems that you may be currently dealing with.
Naturally, we also encounter cases where the client itself has no idea what services it might need as part of the MDR implementation. In such cases, the first step in our cooperation is usually a personal meeting where we explain everything that is needed. The next step is usually a thorough analysis of the existing situation, during which we distinguish the documents and processes that really need to be changed according to MDR from those that can be maintained in order to minimize the number of interventions in the functioning system and thus the client’s costs.
How can you contact us?
Please leave your contact details in the contact form below. We will then contact you promptly to discuss how to proceed, depending on your needs. By submitting an enquiry you do not commit to anything.
Why choose us?
We are a law firm, so unlike many providers and consultants, we provide our legal services officially and legally, and we are legally insured in case of liability for damages.