Medical Device Regulations (EU)

What's included:

• Grab an enrolment letter as a gift!
• Eligibility to earn a CPD & QLS endorsed certificate.
• Fully Online Recorded Class
• 24/7 & Lifetime Access
• Online support
• No hidden fees

This specialised course on Regulations (EU) for medical devices is crafted to provide a solid grasp of the evolving framework governing device safety, classification, risk management, and post-market surveillance. It equips learners with the essential understanding of how Regulations (EU) impact everything from design and development to reporting obligations, technical documentation, and CE marking for medical devices across European territories.

Whether you are part of a medical manufacturing team, regulatory affairs, or a quality control division, staying aligned with the latest Regulations (EU) is essential to ensure compliance with MDR. The course offers structured insights into roles and responsibilities, regulatory pathways, and the importance of vigilance reporting. It focuses on instilling the confidence required to interpret, apply, and manage Regulations (EU) in a manner that supports product lifecycle and patient safety, without being overwhelmed by legislative jargon or interpretive grey areas.

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Learning Outcomes

• Understand the legal foundation of Regulations (EU) for medical devices.
• Learn device classification under current Regulations (EU) rules.
• Identify the role of economic operators under Regulations (EU).
• Manage documentation as per Regulations (EU) requirements.
• Recognise post-market responsibilities within Regulations (EU).

Who is this course for?

• Regulatory officers working with EU medical device rules.
• Quality managers overseeing product compliance and documentation.
• Medical device manufacturers aiming for EU market access.
• Consultants providing guidance on Regulations (EU) standards.
• Individuals entering healthcare device regulatory fields.

Career Path & Average UK Salaries

• Regulatory Affairs Officer – £38,000 per year
• Medical Device Auditor – £45,000 per year
• Quality Assurance Specialist – £40,000 per year
• Clinical Evaluation Manager – £48,000 per year
• Medical Device Consultant – £52,000 per year
• Product Lifecycle Manager – £44,000 per year