If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.
Unannounced notified body audits are nothing new. Unfortunately, because of one really bad apple in the industry and a perception of the regulatory environment in the EU lacking teeth, the Commission has come up with an unrealistic and expensive solution for industry.