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In Vitro Diagnostics Regulation (IVDR)

The government state that the MDR will come in to effect in May 2020, and the IVDR in May 2022, however the United States has called upon the EU to delay the implementation of Medical Device Regulations and In Vitro Diagnostic Regulations by 3 years. Read more

News

The new Europe-based conference plans to build on The Regulatory Affairs Professionals Society’s (RAPS) track record of successful events at a time where there are many changes within the European regulatory environment. Read more

News

Carl Mendonça, Ultrapolymers, outlines polymer choice considerations for successful plastics device components. Read more

Opinion

Vicki Anastasi, and Karen Hill, ICON, examine the key challenges associated with the new EU MDR and IVDR Read more

Opinion

With Brexit looming, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) discusses how medical device companies should respond to the EU's new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read more

Opinion