Roundtable debate: MEP welcomes dialogue on new legislation

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TOPRA organised a roundtable discussion where regulatory affairs professionals had the opportunity to meet Marina Yannakoudakis, MEP. The event took place on 10 January 2013 at the Royal Society.

Marina is an MEP for the London region in the UK and sits on the ENVI committee, the Environment, Public Health and Food Safety committee within the European Parliament.

The role of ENVI is to scrutinise legislation proposed by the EU Commission. Three forthcoming pieces of legislation are of particular interest to regulatory professionals, covering clinical trials, medical devices and in-vitro medical devices.

In reviewing these legislative proposals Marina tries to engage with as many stakeholders as possible to elicit their views. Her aim is to find out what is truly important and what can give way in the legislation if necessary. As a London MEP, Marina will also do what is good for her constituents, for example in terms of job creation.

Clinical trials

The aim of the legislation is speedier approvals and hence saving in money for academia and industry whist maintaining patient safety. The discussion covered risk, data retention, interventions, reporting procedures, insurance and transparency of clinical data.

Marina felt the chances of this legislation getting through before the end of this parliamentary term were slim.

Devices

The current legislation is very old; new regulations need to take account of changes in technology and recent issues concerning the control of devices in the market.

The discussion touched on unique label identifiers, implant passports, central manufacture database, clinical data database, notified bodies and conformity assessment.

Marina felt that there was a good chance this legislation would be on the stature books by the end of this parliament.

In-vitro medical devices

The in-vitro medical devices legislation was discussed briefly. It has a wider scope than the old legislation, covering new technology. As with the devices legislation, there will also be more classes.

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