The EU medical devices regulation
The rise of such combination products means that the integration of pharmaceutical and device regulatory requirements at the development stage is more important than ever before.
The most significant change for devices such as autoinjectors is that now the device is no longer considered as just secondary packaging under medicinal regulations.
Combination products such as autoinjectors or pressurised metered dose inhalers (pMDIs) – are governed by strict regulations in the European Union (EU) and other advanced markets. Pharmaceutical developers must demonstrate compliance with these requirements to deliver a safe and effective product to patients and trade within those territories.
Failure to ensure products meet these updated requirements could mean that pharmaceutical companies are unable to market their products in the EU. Not only would this impact on their revenue, but it would also have a negative effect on the patients that rely on their treatments.
In an article with IPI Magazine, Our Head of Regulatory and Compliance at Bespak by Recipharm, Nadine Kasidas-Neale, explains the incoming changes to EU medical device regulations and their impact on pharmaceutical companies developing drug delivery devices, including autoinjectors for the EU market.
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