Quality First International has published a guidance book to raise awareness and preparedness of medical device manufacturers with regard to Regulation (EU) 2016/679, encompassing additional elements of the UK Data Protection Act 2018. This sector-specific guidance has been developed to help manufacturers understand and apply personal data protection obligations in the medical devices’ area.
London-based medical device regulatory consultancy Quality First International (QFI) has published a Medical Device Guidance Book: Guidance on application of Regulation (EU) 2016/679 on data protection to medical devices in the European Union and United Kingdom – Understanding and practice to help manufacturers achieve compliance with the pertinent regulations in the European Union and the United Kingdom.
“The guidance is motivated by recognition that the medical device sector is generally oblivious or cavalier about personal data protection and therefore might be ill-equipped to comply; or worse, exposed to enforcement that could otherwise be avoided easily.”, says Haroon Atchia, CEO and co-founder of QFI. “Fines can be huge for non-compliance with the regulations and this guidance can be used to apply the regulations to improve understanding and practice in the area of general personal data protection.”
The guidance book is available from QFI upon request, please contact [email protected]. 178 pages, PDF, Price: 249 GBP.