Regulatory Affairs Professionals Society 129 The New Medical Device Regulation and In Vitro Diagnostic Device Regulation By Gert Bos PhD, FRAPS and Erik Vollebregt, LLM Chapter 12 OBJECTIVES T Gain insight into the revised European medical devices and IVD legislation T Understand the major changes in these new regulations T Become aware of the transitional regime and preparatory requirements for companies in the medical device and IVD industries DIRECTIVES, REGULATIONS AND GUIDELINES COVERED IN THIS CHAPTER T Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (EU-EU-MDR) T Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (EU-EU-IVDR) Introduction The EU has spent the last decade on a radical overhaul of its medical devices legislation. The new Medical Device Regulation (EU MDR) and In Vitro Diagnostic Device Regulation (EU IVDR) will provide a new regulatory frame- work for medical devices in the EU for the coming decades. They are constructed with a series of implementing and delegated legislation that will allow them to be revised and fine-tuned in almost every detail. In this way, the future will see incremental legislation rather than another massive regulatory overhaul. The first additional legislative pieces are expected to be introduced in late 2017 or early 2018. The proposals were initiated in 2007 and finalised in 2012, after which a number of years of political and technical debates followed until their final publication in Q2 2017. The EU MDR will replace the existing Medical Devices Directive (MDD, Directive 93/42/EC) and Active Implantable Medical Devices Directive (AIMDD, Directive 90/385/EEC), while the EU IVDR will replace the IVD Directive (Directive 98/79/EC). Essential in the legislative reform is that it will form a clearing house for all legacy products and operators. As such, there intentionally is no grandfathering for products already CE-marked, and no grandfathering for Notified Bodies. Why a new EU MDR and EU IVDR? The revision of EU medical devices law began in 2007 with informal interactions between the EU Commission and selected stakeholders, followed by two more formal consultations in 2008 and 2010 that aimed to make mid- life updates to the existing directives for medical devices, active implantable medical devices and IVDs. The oldest of the three directives dates back to 1990 and never has been changed substantially. In 2012, when the Commission made its legislative proposals, it felt compelled to amend them significantly following an additional impact assessment related to several highly publicised issues with medical devices in the EU market, such as the PIP breast implants, metal-on-metal hip
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