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MDR

What is it?

 

MDR is the abbreviation for new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, which will enter into force on 26.5.2020. 

 

What MDR changes?

 

MDR is directly applicable in all EU Member States, including the Czech Republic and from 26.5.2020 it will be used preferentially over Act No. 268/2014 Coll., on medical devices.

 

MDR and related regulations and ISO standards regulate, for example, new requirements for system for risk management, manufacturers' technical documentation or clinical evaluation of medical devices. MDR also introduces Unique Device Identification system (UDI system), which also brings new administrative and registration obligations. 

 

What can we help you with?

 

We provide advice on MDR to manufacturers, distributors or other subjects of trade in medical devices in all phases of their business.

 

Our advice is mostly on medical devices of class I, that are not subject to certification and where all formal legal requirements must be fulfilled by the manufacturers themselves. However, we also provide advice on other classes of medical devices, such as disputes between manufacturers and Notified Bodies. We are able to guide you through the entire MDR implementation process, as well as help you with an individual problem you may be solving.

 

We commonly encounter situations where a client does not know what services related to MDR implementation might need.

 

In such situations, the first step of our cooperation is a personal meeting to explain everything needed. Then we analyze the existing state and distinguish between documents and processes that need to be changed under MDR from those that can still be maintained to minimize system interference and client costs.  

 

How can you contact us?

 

Please leave your contact information in the contact form below. Then we will contact you immediately and together we will agree on how to proceed. By submitting your request, you are not committed to anything.

 

Why choose us?

 

We are a law office, unlike many other entities, and we offer legal services officially and legally.  

 

 


 

Are you interested in a non-binding request? Call us on +420 735 800 088 or write to e-mail dymacek@dymaceklegal.cz.
You can also use the contact form below.


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Contact form

By sending an inquiry, you do not commit to anything. After processing it, we will contact you and agree on the next step. Information on the processing of personal data can be found here.