Overview of Medical Device Regulatory Affairs Decoding medical device regulatory compliance

Introduction

Regulatory affairs play a vital role throughout the lifecycle of a medical device. It enables medical device manufacturers to devise premarket strategy, drafting regulatory submissions, and ensuring post-market compliance. Here is a quick look at the medical device regulatory affairs market share.

• Global medical devices market $495.46 B (2022) $718.92 B (2029) at a CAGR of 5.5% between 2022-2029.
• European medical devices market $149 BN (2019) $232 BN (2027) at a CAGR of 5.8% between 2020–2027.
• US medical devices market $186.5 BN (2021) $262 BN (2028) at a CAGR of 5% between 2021–2028.
• China medical devices market $53.9 BN (2021) $73.2 BN (2027) at a CAGR of 5.2% between 2021–2027.

Placing a Medical Device in the Global Market – Quick Comparison

As per the current market trend, new product development (NPD), sustenance, and transition are the three main activities where a regulatory affairs specialist has a major role to play. As an example, let us consider the European market with regard to:

Medical device regulatory strategy and phase-wise activity for new product development The regulatory strategy for NPD is carried out in three stages:

EU MDR-2017/745 and EU IVDR-2017/746 sustenance post CE mark

WHY

To continue selling medical devices in the European Union post MDR go-live, manufacturers have to perform

• Relevant incident-driven activities, as per EU MDR-2017/745 and EU IVDR-2017/746
• Mandatory periodic updates for QMS and documentations.

WHERE

These regulations apply in the case of:

• New inclusions amendments in EU MDR or EU IVDR regulations
• Certification renewal/re-submission
• Quality Management System (QMS) new inclusions/updates
• Product/process change
• Vendor/facility change
• Periodic/surveillance audit-triggered feedback/Non Conformance (NCs)

WHAT

The following are covered by these regulations:

• Management of standards and regulations
• STeD/technical file maintenance
• PMS and reporting
• Updating clinical documents such as PMCF, PMPF CER, PER, SSCP, SSP
• Establishing/implementing, and maintaining QMS and Risk Management File (RMF) per regulations
• Implementing EUDAMED/EUDAMED maintenance, including adverse reporting
• Monitoring economic operators—manufacturer/supplier, importer, distributor, authorized representative

EU MDR and EU IVDR NPD, Transition, and Sustenance— Cyient’s Function-Wise Approach

The diagram below represents Cyient’s understanding and function-wise approach for NPD, transition and sustenance. The thought-process behind the below representation is to clearly identify the requirements as per the applicable regulatory requirement and function-wise segregation of tasks/ activities to assign ownership to ensure compliance. The ownership is assigned to associates with right skillsets listed in the bucket below.

CyARC: Cyient’s Accelerated Regulatory Compliance Offering

CyARC is a solution offering to accelerate the Regulatory Compliance process for regulated industries such as- Healthcare. It is an automated solution which intends to replace time taking manual and tedious processes and thereby speeding up time-to-market. CyARC’s intelligent framework utilizes NLP techniques and data clustering algorithms. Powered by a rule-based engine CyARC automatically generates pre-populated regulation checklists and templates, device-specific applicability assessments, and gap analysis. It offers the quickest way to provide design input to R&D engineers. CyARC’s digital database is designed to capture information and knowledge. Capable of scaling up, getting trained with user actions, and continuously improving, CyARC’s architecture is flexible and modular. Considering the state of the art, CyARC is one of the most promising solutions to fast-paced product development and sustenance.

EU MDR Sustenance Roadmap

Placing a Medical Device in the European Market—EU MDD to EU MDR-2017/745 Transition

Conclusion

Most medical device companies are racing against time to ensure compliance to EU MDR-217/745 and EU IVDR-2017/746 in all the above-mentioned scenarios (NPD, sustenance, transition). Cyient offers a one-stop solution, the CyARC – Accelerated Regulatory Platform, to help medical device companies ensure regulatory compliance. Empowered by our Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all the functions with the skillsets and expertise to support medical device companies throughout the life cycle of medical devices.

About the Author

Abhishek Kumar is an SME in medical device regulatory and quality assurance services. With 12+ years of experience, he has successfully led multiple engagement programs for Europe, US, China, ASEAN markets for NPD and sustenance. Additionally, Abhishek has prepared and implemented the regulatory plan for NPD for 90+ countries by analyzing project feasibility, freezing regulatory requirements, and coordinating with various cross-functional teams.