2019-10-01T15:14:00+01:00By Daniela Drago, Agung Purnama
In the EU, the development of medical devices is supported by the European Commission Directive (93/42/EEC Medical Devices Directive). To this, the EU has a unique system in dealing with medical devices, iconised as the CE Marking, which provides the right for the products to be commercialised in the EU. This continuing professional development supplement presents the unique system of medical devices that is currently applied in the EU. Additionally, the new regulation of medical devices (EU 2017/745 Medical Device Regulation) is also covered.
This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).
2019-10-01T15:31:00+01:00By Agung Purnama, Daniela Drago
The Poly Implant Prothèse (PIP) silicone breast implant failures had a socioeconomic impact at an international level, affecting nearly 400,000 patients in 55 different countries, and resulted in major EU regulatory updates. PIP was a French company founded in 1991 and it produced approximately two million sets of silicone breast ...
2019-05-01T16:08:00+01:00By Agung Purnama, Daniela Drago
Peripheral arterial disease (PAD) affects around 8–12 million people in the US. The strong association with ageing, tobacco smoking, and diabetes means that the prevalence of PAD will continue to increase in the coming years. Although 20–50% of patients with PAD are asymptomatic, they are still at significant risk of ...
2019-05-01T15:59:00+01:00By Agung Purnama, Daniela Drago
The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.
This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
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