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New EMA Guidance to Help Pharmaceutical Companies Prepare for Brexit

United Kingdom, European Union - January 9 2018 As of March 30, 2019, the United Kingdom will become a “third country.” Applicants and marketing authorization holders (MAHs) of...

Maarten Meulenbelt.

New EU Medical Device Regulations - Immediate Impact and Moving Targets

European Union - May 5 2017 The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) were published on May 5, 2017...

Josefine Sommer, Anna-Shari Melin, Maarten Meulenbelt.

EU Institutions Agree on Overhaul of Medical Device and IVD Rules

European Union - June 23 2016 On June 15, 2016, the European Council's Permanent Representatives Committee and the European Parliament's Environmental Committee, supported by the...

Josefine Sommer, Nancy K. Stade, Maarten Meulenbelt.

New EU Novel Food Regulation Eases Access to European Market

European Union - December 11 2015 Today, the new EU Novel Foods Regulation was published in the EU's Official Journal. The new Regulation, which will apply as of January 1, 2018...

Josefine Sommer, Maarten Meulenbelt.

EU addresses regulation of “standalone software” as a medical device

European Union - October 26 2015 Recognizing the need for a clear European legal framework for the regulation of standalone software as a medical device, the European Commission...

Josefine Sommer, Maarten Meulenbelt.