combination products

Article

What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]

Article

Bridging the regulatory gaps for combination product makers

New combination products are being developed to fulfil unmet medical needs but the regulations are taking time to catch up. Shayestey F├╝rst-Ladani and Lindsay Kostadinov report from a conference where drug and…

Article

From Borderline to Border Area

Traditionally the borderlines between different categories of regulated products (medicinal products, medical devices, food, cosmetics, etc.) have been looked at as strict lines. More and more however it becomes evident that although…

Article

Update on EU medical devices Recast regarding combination products

The DIA Euromeeting in Geneva was an excellent opportunity to meet a number of the regulators involved in the process of the Recast of the EU medical devices directives. Since a lot…

Navigate through our knowledgebase