All CE marking articles
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FocusPractical insights into the recent EU MDR framework
This article focuses on the impact of the new guidance document on drug-device combination (DDC) products, in Article 117 of the European Medical Device Regulation (MDR) for pharmaceutical marketing authorisation holders (MAHs). It explores the new role of the notified body (NB) versus the MAH pertaining to the device part of the DDC, some of the pitfalls encountered by pharmaceutical MAHs and potential solutions to efficiently navigate the new framework. It also provides practical insights into key technical requirements for the product-specific quality aspects of a medical device, which are within the quality dossier of a successful EU application. The article also explores efficient global implementation within fast evolving and at times divergent, regional regulations.
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Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.
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JournalEU PIP breast implant withdrawal
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,[1] 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 ...
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JournalFundamentals of the European devices regulatory framework
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.