EU and UK Medical Device Regulations are among the most complex and stringent regulatory frameworks in the global healthcare industry - the process for achieving market authorization involves navigating the comprehensive Medical Device Regulation (MDR), UK Medical Device Regulations (UK MDR), conformity assessment procedures, and multiple quality management system requirements. The regulatory landscape demands compliance with over 175 pages of detailed legal requirements spanning classification systems, clinical evaluation protocols, and post-market surveillance obligations.
This certified program is designed to provide you with comprehensive expertise to navigate these intricate regulatory requirements and empower you to successfully overcome the complexities of medical device compliance across European markets. You will develop expertise across critical regulatory domains, including the EU MDR and UK MDR frameworks, medical device classification and risk categorization systems, conformity assessment pathways, and Notified Body selection strategies. You will gain deep insights into clinical evaluation and clinical investigation requirements, quality management system implementation, technical documentation preparation, and the complexities of Unique Device Identification (UDI) systems and European Database on Medical Devices (EUDAMED) compliance.
Furthermore, this program will help you attain advanced practical competencies to integrate regulatory requirements into product development lifecycles, ensuring seamless compliance from conception through post-market surveillance. This includes mastering the intricacies of compliance strategies for EU and UK markets, understanding authorized representative obligations, and adapting to evolving regulatory interpretations and guidance documents. You will also gain proficiency in risk management protocols, vigilance reporting systems, and effective regulatory submission strategies that minimize approval timelines and maximize compliance success rates. By the end of the program, you will be positioned to lead medical device regulatory initiatives, equipped with the strategic knowledge and practical tools necessary to mitigate compliance risks and achieve sustainable market authorization.
Upon successful completion of the program, you will attain the Certification in EU & UK Medical Device Regulations and Compliance. This distinguished certification will demonstrate your expertise in EU and UK MDR compliance, quality systems and strengthen your professional credentials. Globally demanded and recognized, this industry-recognized certification also holds lifelong validity and will empower you drive informed decisions and best practices in the evolving EU and UK medical device markets.
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This program will entitle you:
Pricing & Registration- Experience 2 days of instructor-led live training and delve into the comprehensive UK and EU regulatory landscape, including the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), post-Brexit UK MDR 2002, the complexities of medical device qualification, and the roles of notified bodies and conformity assessments.
- Attain the industry-recognized Certification in EU & UK Medical Device Regulations and Compliance. This certification enhances your qualifications, showcasing your expertise in EU and UK medical device regulations and your ability to navigate compliance, quality management, and clinical requirements across Europe and the UK.
- Master ISO 13485:2016 and ISO 14971 implementation, integrate them with EU MDR and UK MDR 2002 requirements, and ensure compliance with evolving EU and MHRA expectations through effective risk management and post-market surveillance.
- For inquiries, chat with our Program Advisers at advisor@charteredcertifications.com or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
Recent studies have revealed that over 90% of medical devices now require Notified Body involvement under the current regulations, compared to just 15% under previous directives, while conformity assessment timelines have extended from 6-8 months to 12-18 months or longer. Additionally, technical documentation requirements have increased by 150-300%, and clinical evidence costs have escalated by 200-400% across most device categories, creating substantial barriers for manufacturers seeking EU and UK market access.
This certified program is designed to provide you with an in-depth understanding of these intricate frameworks and equip you with the tools to effectively navigate the regulatory landscape. You will gain expertise in critical areas such as EU MDR and IVDR compliance, UKCA and CE marking pathways, conformity assessment procedures, clinical evaluation and investigation requirements, and post-market surveillance obligations. You will also gain insights into the technical documentation process, Unique Device Identification (UDI) and EUDAMED database registration while addressing regulatory challenges.
Furthermore, this program will provide you with practical skills to integrate regulatory requirements into product development, quality management systems, and lifecycle management. You will learn to address the challenges of multi-jurisdiction compliance, manage interactions with notified bodies and regulatory authorities, and prepare for audits and inspections. Additionally, the program will cover emerging challenges such as digital health technologies, AI-driven devices, and cybersecurity obligations, ensuring that you are prepared for the future of medical device compliance. By the end of the program, you will be equipped with the strategies to mitigate risk, reduce delays, and maintain market access across the EU and UK.
Upon successful completion of the program, you will receive the Certification in EU & UK Medical Device Regulations and Compliance, enhancing your professional credentials and demonstrating your mastery in ensuring product safety, efficacy, and regulatory adherence. Internationally recognized and valued by leading medical device manufacturers, regulatory consultancies, and healthcare organizations worldwide, this certification maintains lifelong validity and will establish you as a trusted authority in medical device regulatory affairs, substantially enhancing your career prospects in this critical and rapidly evolving field.
Key Skills You Will Gain
- Medical Devices Directive (MDD)
- UK MDR 2002
- Medical Devices Regulations (MDR) Compliance
- IVDR Understanding
- Device Classification
- Risk Assessment
- Quality Management
- UK UDI Systems Management
- ISO 13485 Compliance
- ISO 14971 Application
- Clinical Evaluation
- Regulatory Submissions
- UK Approved Bodies Navigation
- Quality Management Systems (QMS)
- Notified Body Interaction
- Technical Documentation
- Post-Market Surveillance
- Adverse Event Reporting
- EUDAMED Data Management
- Clinical Development Plan (CDP)
- Declaration of Conformity (DoC)
- Post-Market Clinical Follow-Up (PMCF)
- Unique Device Identification (UDI) System
- Person Responsible for Regulatory Compliance (PRRC)
- CE (Conformité Européenne) Marking
- UKCA Marking
- Field Safety Corrective Actions (FSCA)
- Conformity Assessment
- MHRA Registration
- Standard of Care (SoC)
Your Faculty Director
Asha Jacob is a distinguished leader in regulatory affairs and compliance within the MedTech industry, boasting an impressive 18-year career. Her expertise spans across R&D, regulatory affairs, clinical affairs, medical writing, quality assurance, and quality management. Currently, she serves as the Head of the Regulatory Affairs and Compliance team at Philips Medical Systems in the Netherlands. Asha also holds the crucial roles of EU Authorized Representative Officer for EU MDR & EU IVDR and Person Responsible For Regulatory Compliance-2 at Philips.
Asha's holistic, cross-functional understanding of EU MDR has enabled her to guide both business and market organizations through regulatory complexities. Her expertise is further validated by BSI training in MDR Implementation for CE Marking and CQI & IRCA ISO 13485:2016 Auditor/Lead Auditor Certification, underscoring her commitment to maintaining the highest standards in regulatory affairs and compliance.
EU & UK Medical Device Regulations and Compliance Program Agenda
How You Will Benefit
- Master EU and UK MDR Frameworks: Gain comprehensive expertise in navigating the EU MDR, IVDR, and UK MDR regulatory systems with confidence.
- Understand Device Classification: Learn medical device classification, risk categorization, and conformity assessment procedures for compliance success.
- Optimize Notified Body Strategies: Acquire skills to evaluate and select appropriate Notified Bodies for faster market authorization.
- Strengthen Clinical Compliance: Understand clinical evaluation and clinical investigation requirements to ensure regulatory approval.
- Implement Quality Management Systems: Develop the ability to design, apply, and audit effective QMS in line with EU and UK standards.
- Navigate Documentation and Databases: Gain proficiency in preparing technical documentation, managing UDI systems, and achieving EUDAMED compliance.
- Integrate Regulations into Product Lifecycles: Learn to embed compliance requirements into product development, from conception to post-market surveillance.
- Manage Multi-Jurisdiction Compliance: Develop strategies to handle obligations across EU and UK markets, including authorized representative roles and evolving guidance.
- Enhance Risk and Vigilance Protocols: Build expertise in applying risk management frameworks, vigilance reporting, and regulatory submission strategies.
- Address Emerging Compliance Challenges: Prepare for future demands, including digital health technologies, AI-driven devices, and cybersecurity obligations.
Certification in EU & UK Medical Device Regulations and Compliance
Upon successfully attending this program, you will be awarded with the Certification in EU & UK Medical Device Regulations and Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity. Globally demanded and recognized, this certification underscores your expertise in managing complex regulatory environments, elevating your professional standing and effectiveness in ensuring medical device compliance across international markets. This program is developed by Chartered Institute of Professional Certifications and the content of this program has been certified by CPD Certification Service as conforming to continuing professional principles.
Pricing & Registration
EU & UK
Dates: 24 - 25 Mar 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm Greenwich Mean Time (GMT)
10:00am - 5:30pm Central European Time (CET)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 09 Jan 2026 | By 20 Feb 2026 | After 20 Feb 2026 | |
| EU Delegates | EUR 1,395 | EUR 1,595 | EUR 1,695 |
| Switzerland Delegates | CHF 1,295 | CHF 1,495 | CHF 1,595 |
| UK Delegates | GBP 1,195 | GBP 1,395 | GBP 1,495 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
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EU & UK Medical Device Regulations and Compliance
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