Compliance With EU MDR and UK MDD

Navigating multiple regulatory environments is not uncommon for global companies. However, it can be difficult to implement mandated changes close to home, especially when multiple quality regulations are changing at once.

Read this brief to learn the differences between UK and EU regulations for medical device manufacturers. See how an electronic quality management system (eQMS) can help you achieve dual-regulatory compliance and give you an edge against your paper-based competitors who are struggling to catch-up.

Differences between UK and EU regulatory bodies and processes.
Impacts on medical device manufacturers.
How an eQMS reduces the cost and effort of compliance.
What actions are needed to get and keep products on the market.

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UK & EU Compliance Roadmap: Navigating Pharma Regulations

Aligning With the EU MDR

What are the key changes introduced by the EU MDR in terms of quality regulations?

The EU MDR is more stringent than previous directives and four times longer. There are more requirements for robust quality management, including quality assurance, risk management, and postmarket expectations.

How does the EU MDR affect the classification of medical devices from a quality perspective?

Instead of distinguishing medical devices by name or function, the EU MDR classifies devices depending on the level of risk to the patient. The classification rules determine the quality standards and conformity assessments that must be completed before a device can be released to market.

What are the timelines and deadlines for transitioning to EU MDR quality regulations?

The current EU MDR and EU IVDR are now fully enforced. As of May 2021, medical devices manufacturers must comply with the EU MDR. May 26, 2024 is the last date to submit applications for legacy device extensions.

What are the potential consequences of non-compliance with EU MDR quality regulations?

Failure to comply with EU MDR quality regulations will make it impossible to legally market a product in the EU. Other penalties for noncompliance can include warnings, fines, delays, recalls, shutdowns, and so forth.

UK and EU Quality Regulations Explained

Expertly navigate EU quality regulations and be proactive to stay compliant.

Successful Compliance: How Confident Are You?

Transitioning to EU MDR

Medical device manufacturers must recertify legacy devices to meet new regulations outlined in EU MDR.

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Compliance Software

Dual regulations shouldn’t mean double the work. Use software purpose-built for life sciences companies and achieve efficient, cost-effective compliance.