Tag: changes medical device regulation


Overview of the role of Key Stakeholders in the Medical Device Regulations

The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. These obligations need to be fulfilled to ensure compliance with the regulation when placing the device on the market. Manufacturer Dependent on classification of the device, will get a CE certificate from the Notified Body or self-certify the device. Affix CE mark. Responsible for placing CE marked product on the market. Responsible for registering products on the EUDAMED database Retain technical documentation, CE......

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Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

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Why is regulatory strategy so important?

The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a......

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