The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical ...
LE MONT-SUR LAUSANNE, Switzerland--(BUSINESS WIRE)--Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and ...
As the EU’s new system for regulating medical devices takes effect, some medtech companies are finding the process of securing new authorizations for their previously authorized devices ...
On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health ...
LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...
The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...
LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make ...
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