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Essentials of European Medical Device Regulations Level 1
High Skills Training

*Complete 3 Courses in One Bundle* | PDF Certificate | Lifetime Access | Expert Help | 14-Day Money-Back Promise

Summary

Price
£19 inc VAT
Study method
Online, On Demand 
Duration
2.7 hours · Self-paced
Qualification
No formal qualification
Certificates
  • Reed Courses Certificate of Completion - Free
Additional info
  • Tutor is available to students

Add to basket or enquire

Overview

Last Update: January 2026

Essentials of European Medical Device Regulations Level 1 – 3-in-1 Compliance Bundle

★★ Trusted by 1000+ Industry Professionals ★★
CPD-Accredited | Learn Anytime, Anywhere | Regulatory & Compliance Expertise

Enhance your knowledge of medical device regulations with HighSkills Training’s Essentials of European Medical Device Regulations Level 1 course bundle. Perfect for professionals in medical device manufacturing, regulatory affairs, quality assurance, and healthcare compliance, this online training ensures you understand both EU and UK regulatory requirements.

3-in-1 Course Bundle – Individual Prices

1. Essentials of European Medical Device Regulations Level 1 – £25.00

  • Learn the structure, purpose, and scope of EU MDR 2017/745.

  • Classify medical devices correctly and follow appropriate regulatory pathways.

  • Understand roles of manufacturers, importers, and authorised representatives.

  • Ensure compliance through documentation, risk management, and post-market surveillance.

2. UK Medical Law (Bonus) – £25.00

  • Explore consent, confidentiality, medical negligence, and duty of care.

  • Gain essential knowledge for regulated healthcare and clinical roles.

  • Apply legal principles to daily compliance and patient safety practices.

3. Health and Safety at Work (Bonus) – £25.00

  • Understand workplace legal obligations, including risk assessments, COSHH, manual handling, and emergency procedures.

  • Learn to maintain safe work environments in manufacturing and clinical settings.

Total individual course value: £75. Bundle pricing available on enrolment.

Learning Outcomes

  • Achieve CPD-accredited certification in EU and UK medical device compliance.

  • Apply regulatory principles in real-world manufacturing, clinical, and quality assurance settings.

  • Understand your responsibilities under UK medical law and workplace safety regulations.

  • Master key compliance concepts with unlimited MCQ-based assessment retakes.

  • Study fully online at your own pace with access to expert tutor guidance.

Why Choose HighSkills Training?

  • CPD Certified: Recognised in healthcare, life sciences, and regulatory sectors.

  • Flexible Online Learning: 24/7 access from desktop, tablet, or mobile.

  • Unlimited Assessment Retakes: Learn without pressure and perfect your knowledge.

  • Dedicated Tutor Support: Guidance from regulatory and compliance professionals.

  • 14-Day Money-Back Guarantee: Enrol risk-free with peace of mind.

Student Testimonials

★★★★★ “A must for anyone in MedTech. Clear, practical, and easy to follow. The UK Medical Law module was especially useful.” — Amelia D.

★★★★★ “Comprehensive and relevant. The bonus courses gave me a wider perspective on compliance and workplace safety.” — David H.

Take Control of Medical Device Compliance

Enrol today in HighSkills Training’s Essentials of European Medical Device Regulations Level 1 Bundle and build the foundation for a successful career in regulatory affairs, quality assurance, and healthcare compliance.

Certificates

Curriculum

4
sections
12
lectures
2h 44m
total

Description

Course 1: Essentials of European Medical Device Regulations Level 1

Section 1: Understanding the Basics of European Medical Device RegulationsLecture 1: Introduction to European Medical Device Regulations

  • What Is the European Union Medical Device Regulation?
  • EU Directives of Medical Devices
  • The Impact of Medical Device Regulations in the European
  • Terms and Definition of EU Medical Device Regulations

Section 2: Technical Documentation RequirementsLecture 2: Essentials Components of EU MDR

  • Technical Documentation of Medical Devices
  • Classification Rules for Medical Devices
  • Clinical Evidence and Post-Market Surveillance

Section 3: Essential Design and Manufacturing Requirements for Medical DevicesLecture 3:Requirements for Design and Manufacture of Medical Devices

  • Chemical, Physical and Biological Properties
  • Design and Manufacture of devices
  • Justification of the Presence of CMR and Endocrine-Disrupting Substances
  • Follow Guidelines on Phthalates and Endocrine-disrupting Substances
  • Labelling
  • Infection and Microbial Contamination
  • Protection from Radiation
  • Particular Requirements for Active Implantable Devices
  • Protection against Mechanical and Thermal Risks
  • Protection against Devices Supplying Energy or Substances
  • Protection against Devices Intended by the Manufacturer for Use by Lay Persons

Section 4: Medical Devices Identification, Traceability and Reporting Adverse EventsLecture 4: Requirements for Identification, Traceability and Reporting Adverse Events

  • Unique Device Identifier for the Traceability of Medical Device
  • European Database on Medical Devices (EDUAMED)
  • Reporting Procedures for Adverse Events

Section 5: EU Regulations for the Quality Management of Medical DevicesLecture 5: Quality Management System for Medical Devices for EU MDR

  • Medical Device Quality Management System (QMS)
  • International Standards and Regulations for Medical Device QMS
  • How to Implement Quality Management Systems on Medical Devices
  • Quality Management System for EU MDR

Course 2: Uk Medical Law
Course 3: Health and Safety at Work

Who is this course for?

The Essentials of European Medical Device Regulations Level 1 course is ideal for individuals working in, or aspiring to enter, the medical device and healthcare compliance sectors. It’s particularly suited for:

  • Regulatory Affairs Assistants and Officers

  • Medical Device Manufacturers and Technicians

  • Quality Assurance and Compliance Professionals

  • Healthcare Administrators and Managers

  • Clinical Research Associates

  • Product Development and R&D Staff in MedTech

  • Healthcare Professionals looking to understand device regulations

  • Anyone preparing for a role involving EU MDR compliance or UK medical law

Requirements

There is no prerequisite for this. Don’t worry—we will teach you everything step by step.

Career path

Here are relevant job positions in the UK that align with this course:

  • Regulatory Affairs Assistant

  • Regulatory Compliance Officer

  • Clinical Trials Assistant

  • Medical Device Technician

  • Medical Device Manufacturing Operative

  • Product Compliance Administrator

  • Technical File Coordinator

  • Healthcare Compliance Officer

  • Post-Market Surveillance Coordinator

  • Clinical Research Support Staff

Questions and answers

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Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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