The current articles in this issue
Three topics that MedTech companies and medical device manufacturers are currently dealing with – categorized by our regulatory experts
Health Data and the GDPR in Workplace Chats: When a Diagnosis Becomes “Information for Everyone”
A WhatsApp group for scheduling shifts, an annoyed comment about covering someone’s shift, and, right in the middle of it all, the diagnosis of a sick coworker: The Siegburg Labor Court views this as a violation of the GDPR that justifies an injunction and damages. The defendant must personally pay 1,000 euros, because a chat group does not become private simply because it was created as a private group.
Product Liability for Medical Devices: An Overview of the New Law
The new Product Liability Act tightens product liability requirements for software used in medical devices. The more digital systems continue to learn or receive updates after they are placed on the market, the more important the question becomes: development risk or manufacturer control? It is precisely this distinction that will determine liability for medical devices in the future.
BAYOOCARE supports MedTech companies, pharmaceutical companies and international manufacturers from the initial product idea to worldwide market approval. As a certified legal manufacturer in accordance with MDR and IVDR, we assume full regulatory responsibility – so that you can concentrate on development and sales.
The Regulatory Update is part of our commitment to keeping our customers and partners up to date at all times – because regulatory knowledge is a decisive competitive advantage today.
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