Know your regulatory route to market

Know your regulatory route to market

For this webinar we are delighted to be joined by Julian Hitchcock, Intellectual Property and Regulatory Lawyer at Denoon Legal, with a particular focus on life science intellectual property and regulation. Julian’s extensive experience in the field means he is frequently involved in UK and EU policy matters, with his work extending to medical devices, genomic/personalised medicine/ bioinformatics and m-health.

The nature of healthcare means that the level of regulation is high, and it is essential that small companies understand the applicable regulations surrounding their innovations prior to reaching a stage of development where compliance becomes difficult or impossible to obtain.

There are a number of key regulations that commonly risk being stumbling blocks for innovators, but these mainly centre on the following areas:

  • Data Protection
  • Medical devices

Failure to understand and address appropriate regulatory approval for your innovation can act as a barrier to entry for the market, so don’t be caught out.

In the context of these key regulations, Julian covers:

  • The regulatory landscape for healthcare innovation: What SMEs need to know
  • Steps to check your compliance
  • Where to look if you’re not sure

Additional Resources

MHRA Device Determination Guide

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MEDDEV Classification Tree


Our thanks to Julian for sharing his expertise with us