The EU MDR and IVDR have been approved. So, what’s next?

Susan Gosnell Life Sciences Leave a Comment

On April 5th Europe finally adopted the MDR and IVDR after a vote at the European Parliament. This was the last step in the European Union’s long process of overhauling medical device and IVD regulation. The new regulations on medical and in-vitro diagnostic medical devices will help to ensure that all medical devices – from heart valves to sticking plasters …

Medical device

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Life Sciences Leave a Comment

The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …

Common UDI label mistake: The barcode prints over the edge of the label

UDI labeling: common mistakes and best practices

Marko Vrbnjak Life Sciences Leave a Comment

There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …

Speach at UDI compliance conference

Europe is closely watching UDI

Marko Vrbnjak Life Sciences Leave a Comment

The conference was a UDI-dedicated networking and learning meeting for device manufacturers and healthcare providers. The focus was on how they can support each other to benefit the patients. I recently attended and presented at the UDIs & Traceability for Medical Devices Forum in Munich. A prominent theme at the event was technology and how compliance to UDI and other …