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Technical Documentation and the EU Declaration of Conformity Course & Certification
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Technical Documentation and the EU Declaration of Conformity
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About
Technical Documentation and the EU Declaration of Conformity provides a practical overview of the regulatory requirements for documenting and demonstrating medical device conformity under EU MDR 2017/745. It helps learners understand the structure and content of technical documentation, device description and specifications, General Safety and Performance Requirements (GSPRs), risk management, clinical evaluation, and supporting verification and validation evidence.
This course covers the preparation and maintenance of technical documentation, labelling and instructions for use, evidence traceability, conformity assessment, and the content and preparation of the EU Declaration of Conformity. It also explains the relationship between technical documentation, notified body assessment, and applicable regulatory obligations. Upon successful completion, learners will gain practical knowledge to support regulatory compliance, improve documentation quality, strengthen audit readiness, and demonstrate that medical devices meet applicable EU regulatory requirements.
Who Should Enrol?
- Medical Device Regulatory Affairs Professionals
- Quality Assurance and Quality Management Professionals
- Technical Documentation Specialists
- Regulatory Compliance Professionals
- Medical Device Manufacturers
- Professionals Responsible for EU Declarations of Conformity
- Risk Management and Clinical Evaluation Professionals
- Anyone involved in medical device conformity assessment and EU MDR compliance
What you will learn
Understand the structure and regulatory requirements of technical documentation under EU MDR 2017/745, including device description, specifications, design and manufacturing information, and General Safety and Performance Requirements (GSPRs).
Learn how to prepare, organise, and maintain technical documentation, including risk management, clinical evaluation, verification and validation evidence, labelling, instructions for use, and traceability of supporting documents.
Develop practical knowledge of the EU Declaration of Conformity, including its required content, applicable legislation, device identification, manufacturer details, and the responsibilities associated with declaring regulatory conformity.
Understand how technical documentation and the EU Declaration of Conformity support conformity assessment, notified body review, regulatory compliance, audit readiness, and the demonstration of medical device safety and performance throughout the device lifecycle.
Course Syllabus
- One obligation, four sentences, and a test that is not a format
- The addresses, and the areas grouped by what they are for
- There is no such thing as the technical file
- Ten years, fifteen for implantables, and a summary with no format
- The numbers that make the plan enforceable
- Producing it: the authority, and the authorised representative
- The medical device file is not this, and what is in force today
- The index of conformity, and what the section actually asks
- The only official description of the checklist, and its caveats
- A row that survives being read by a stranger
- The presumption of conformity, stated without overclaiming it
- Common specifications, other solutions, and a genuine choice
- Not applicable is a claim, and six ways a checklist fails
- Written first, or written to be contradicted
- Half right, and the half that is wrong is the expensive half
- Navigability, made concrete by the people who read files
- The document set and the submission are two objects
- The proof is published, and the rest has no legal status
- The same fact, stated differently in two places
- Lifecycle: what triggers an update, and why nothing does
- What this module claims, and what it refuses to claim
- The correction: the sampling rules live in Article 52
- The route dependency, and the inversion to refuse
- Annex IX: the quality system, and the assessment of the file
- Annex X and Annex XI: certifying a type, policing production
- Two sampling bases, one product family, and the guidance
- The deficiency evidence, printed only with its denominators
- A proposal that is not law, and an ancestor in Great Britain
- What the declaration says, and the point most often got wrong
- There is no template, and that is a finding rather than a gap
- Article 19 supplies the obligation. Article 20 is named only
- Great Britain: where the duty lives, and what it actually says
- A declaration with no prescribed content, and who holds it
- Great Britain has the sampling rule. What it lacks is the ruler
- Status, Northern Ireland, and what enforcement turns on
- The five corrections, restated and nothing added
- One question per module, and its answer in a sentence
- Failure One to Five
- Readiness Checks One to Two
- The status board
- What would change if the proposal were adopted as published
- What is stable, and what is expected to move underneath it
- 📘 Bonus: Technical Documentation and the EU Declaration of Conformity eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Earn CPD Points to support your professional development in Technical Documentation and the EU Declaration of Conformity under EU MDR 2017/745, subject to applicable eligibility criteria.
Certification
Receive a personal certificate upon course completion to demonstrate your knowledge of Technical Documentation and the EU Declaration of Conformity under EU MDR 2017/745.
Affordable
Get excellent value with cost-effective pricing, plus group discounts for larger purchases.
Flexibility
Learn at your own pace with convenient online access, allowing you to complete the course anytime, anywhere.
Keep Up to Date
Stay informed about technical documentation requirements, EU Declaration of Conformity obligations, relevant regulatory guidance, and updates under EU MDR 2017/745 through regularly reviewed course content.
Learn from Industry Experts
Learn from medical-device regulatory, quality, and compliance professionals through practical insights into Technical Documentation and EU Declaration of Conformity requirements under EU MDR 2017/745.
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