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 […]
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 […]
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 […]
Medical Devices Back in the Spotlight
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: Preparation for the new regulations The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will […]
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Medical Device Regulation: Leveraging expertise from Pharma
When the Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) transition was launched earlier this year, medical device manufacturers were faced with a steep mountain of regulatory, legal, process and resource challenges that would need to be climbed in order to introduce new and continue supplying existing devices for use in healthcare. In […]