Polish Medical Device Law Renewed
or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector.
CE Marking
EU MDR 2017/745 What Changed?
The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?
French & German warning: EU must extend MDR transition period
The French and the Germans warn: The EU must extend MDR transition period. This comes following a meeting with European Commission representatives in Paris on March 14, 2022.
Amendments Machinery Directive 2006/42/EC
New amendments to the harmonised standards of Machinery Directive 2006/42/EC are published in an executive order on April 7, 2022.
Amendments EMC Directive (2014/30/EU)
Amendments EMC Directive (2014/30/EU): the European Commission has recently made
Consultation On RoHS Reform
On March 10, 2022, a public consultation on updating the European Union’s Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (“RoHS”) began. It will end on June 2, 2022.
EU No Longer Priority Market For Medical Device Manufacturers
According to a poll from Boston Consulting Group, the United States has surpassed the European Union as the most important market for medical device makers, with 89 percent of MedTechs planning to prioritize the US Food and Drug Administration (FDA) approval in the future.