EU Medical Device and IVD Regulations have been published - there's no turning back!
We've been waiting a long time for these new regulations! At last, this morning the new EU Regulations for medical devices and in vitro diagnostics were published in the Official Journal of the European Union. So what does this mean? Well in 20 days time, these regulations will pass into law so there really is no turning back!
Question is: is the MedTech sector ready? I think the reality is that for many, the impact of these new regulations on their business and their product portfolio hasn't sunk in yet. In a few months time, however, companies will be waking up to the fact that they really have got to do something about it. Remember, Medical Device companies have a 3 year transition period to achieve compliance with the new regulations whereas IVD companies have 5 years. This is the biggest shake-up of the industry for years and the reality is that many will struggle to cope. Those companies who have been planning their approach to achieve compliance over the past few months will reap the rewards. One of the biggest challenges now is lack of time and lack of resource and many will be appointing external expertise to help determine a strategy and implement this strategy through the respective transition periods.
Global Regulatory Services is here to help. Already we have over a year's experience assessing EU and global product portfolios of multinationals and SMEs against the (draft) EU medical device and IVD regulations to devise strategies and determine a plan for implementation. We'd be very happy to work with you, help you to understand the impact of these new regulations, devise an implementation strategy and then 'hold your hand' through the whole process so that you achieve your goal of achieving compliance. We would like to take the pain away from you and deliver the solution. If you like the sound of this, please email GRS@globalregulatoryservices.com or telephone: +44 (0)1223 750638.