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Asking the Right Questions: Staying Ahead of the CTR and MDR with the EU Legal Representative

The EU legal representative plays a unique role in the life sciences industry and requires a distinctive skill set – with a background in regulatory affairs and quality assurance, but from inside the good clinical practice (GCP) sphere. Now, with the added complexity of the Clinical Trials Regulation and the Medical Devices Regulation, the role […]

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The QA to the Sponsor’s QA: Why the Legal Representative Should be Separate from the CRO

The role of the legal representative for clinical studies – both in pharmaceuticals and now in medical devices under the EU Medical Devices Regulation (MDR) – might be described as quality assurance of the sponsor’s QA role. In future, under the new EU Clinical Trials Regulation (CTR) and MDR, the legal representative will be responsible […]

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Why “Ensuring” the Sponsor’s Compliance is Not the Right Role for CROs

The Medical Devices Regulation will bring massive and rapid change to the industry. Not only must companies adjust to new clinical investigation requirements, but they will suddenly find themselves in need of a number of new experts. Medical device companies wanting to run clinical investigations of their products in Europe will need a qualified person […]

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This Changes Everything: MDR and the Role of the EU Legal Representative

The medical devices industry has changed dramatically in recent years. Historically, medical devices had more in common with product manufacturing industries such as aviation, which meant testing and standards were very engineering focussed: Is the product built robustly? Are the materials adequate for their intended purpose? Will the product and materials last? While those standards […]