Implementation of the New Regulations is a Top Priority for the Industry

16 May 2017

The new medical device regulations have now been voted in as European Law. The deadlines have been set and the staggered transitional period has now begun. You have 3 years to ensure all of your medical devices meet the regulations and 5 years for in-vitro diagnostic medical devices. However, some aspects of the new regulations will become legally binding after 6 months.

Get prepared now to ensure that you meet the guidelines set out in the regulations.

The regulations will bring major changes to the MedTech sector, especially to the in-vitro diagnostic sector. 

For industry some of the most important questions regarding the regulations include:
• What financial impact will the regulations have on SMEs?
• How will the role of the notified body change? Will there be a decrease in the number of notified bodies available?
• How will the regulations impact clinical evaluations, trials and the classification process?

MedilinkWM, in conjunction with Acclaim Biomedical Consulting, is offering a one day intensive course exploring the new regulations. With over 20 years experience in medical devices, Acclaim Biomedical Consulting are best placed to support and advise on the regulatory changes and the impact these will have on existing practice.

Join these courses today to get answers to those burning questions and advice on what steps you should be taking next and when you need to take them. These courses aim to provide delegates with the insight and tools required to plan and implement an organisational strategy for continued access to the European markets.

Impact and Assessment of European Medical Device Regulations | 24 May 2017

Impact and Assessment of European In Vitro Diagnostic Regulations | 29 June 2017