The new EU medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) will begin going into effect in just a few months, at the start of 2020. As a result, some under-prepared manufacturers will be forced to pull some or all of their products off the EU market, while others will face significant delays.

Despite the challenges these reforms will present, they may also introduce a significant opportunity to gain market share and promote new products – but only for companies with a comprehensive business strategy in place. In this paper, we outline steps that device developers must address immediately to maintain market share. These include the need to:

• Overcome the growing shortage of NBs
• Address new clinical data requirements under MDR and IVDR
• Develop a global market entry strategy to capitalise on opportunities
• Consider launching new products in the US and other countries
• Involve top management in compliance efforts