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Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?

July 14, 2018

The publication of the stable text of the European Union (EU) Medical Devices Regulation, and the In Vitro Diagnostic Medical Devices Regulation in June 2016 documents the political agreement between the three EU Institutions – the Commission, the Parliament and the Council – on the contents of the revision of the EU legislation for medical devices. Preparation as regulations means that the legislation will apply directly in the Member States, thereby minimizing the potential for differences being introduced during national adoptions. The availability of this text allows affected organizations to start considering the effects on their activities and what they will need to do in order to be compliant with the revised requirements. The text will undergo legal checking prior to formal adoption.

Spotlight

Hospira

Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. It had approximately 19,000 employees. Before its acquisition by Pfizer, Hospira was the world's largest producer of generic injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems.