Instructions for use - software and sterile devices
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When discussing medical device regulation, it is often said that Class I and IIa devices do not need to be accompanied by instructions...
Veronika Moravová
- Mar 31, 2023
The European Commission's document on the new MDR transition periods addresses some contentious issues
On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council came into force, amending the MDR and IVDR. The...
Aleš Martinovský
- Mar 23, 2023
EMA Expert Panels to Begin with Pilot Projects
For a long time, nothing has been heard about the consultation process for clinical investigation of high-risk devices. As a reminder,...
Aleš Martinovský
- Feb 24, 2023
Are you bothered by nonsensical temperature compliance requirements during distribution?
There is a growing tendency in the field of medical device to shift responsibilities from the manufacturer to the rest of the...
Jakub Král
- Feb 24, 2023
The Constitutional Court set strict rules for health data provision
In the second half of January, the Constitutional Court issued a fairly inconspicuous but absolutely crucial decision for real practice....
Aneta Jaroschyová
- Feb 17, 2023
European Parliament votes to extend MDR transition period
On 15 February 2023, the European Parliament has almost unanimously supported a proposal to amend the EU Medical Devices and In Vitro...
Veronika Moravová
- Jan 19, 2023
Last call for MD manufacturers: Commission proposes conditional extension of the transitional period
On 6 January 2023, the European Commission adopted a proposal to extend the transition period for the re-certification of so-called...
Aneta Jaroschyová
- Dec 14, 2022
Commission wants to extend the end of the MDR implementation transition period, but only for ready manufacturers
The end of the transition period for so-called legacy devices (medical devices provisionally placed on the market on the basis of...
Veronika Moravová
- Oct 14, 2022
Translations of instructions for use: an intractable problem for importers and distributors
Soon we will be moving into the second half of the transition period for "flipping" legacy devices into MDR mode. Unfortunately, as...
Aleš Martinovský
- Jun 10, 2022
New MDCG document limits speculation on medical devices with a medicinal product
Medical devices and medicinal products are two completely differently regulated categories of products that cannot be mixed and confused....
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