Regulation in Life Sciences

Change is coming to the regulatory landscape in the life sciences sector. There is a lot of uncertainty as the market shifts and stakeholders try to understand the changes coming—making the need to plan more urgent than ever. From increased scrutiny of data integrity to the tracking of medicinal products, to changing political landscape and policy changes, today’s shifting regulatory priorities will need to be front and center as you develop your compliance strategies, actions, and investments in 2017 and beyond.

Stay ahead of the curve when it comes to regulatory policy. Here you can find a range of tools within a variety of topics from around the globe that provide critical insight and advice, helping you to anticipate change and plan accordingly. And just as the regulatory landscape continues to change, so will the resources available on this site. We invite you to check back often and benefit from the latest thinking and recommendations as new compliance possibilities and scenarios arise.

EU Medical Device Regulation 

Following the breast implant scandal and the breaking hip replacement incidents, the EU decided to completely revise and align its regulations on medical and in-vitro devices. The new directive will become binding by 2020 for medical devices and by 2022 for in-vitro devices. Manufacturers need to start assessing their porfolio now to implement all the steps necessary to be compliant by 2020.

Read more about the new requirements, how best to assess your compliance and some advises on steps to take toward compliance here.