Together for better patient outcomes
Medical Devices
In healthcare, medical devices play a key role and are vital in diagnosis, screening, monitoring, rehabilitation, treatment, and care. With technological advancements, medical devices are greatly improving the efficiency and quality of healthcare.
Navigating the everchanging regulatory landscape is essential for ensuring that medical devices are safe, effective, and compliant with applicable regulations and standards.
Medical devices range from multi-therapies, such as simple tongue depressors and bedpans, to complex programmable pacemakers and closed-loop artificial pancreas systems. Based on the intended medical purpose, even the software used in devices can also be considered as a medical device (SaMD) as per guidance from the regulatory agencies.
SaMD includes software applications intended for diagnosis, treatment, mitigation, and prevention of diseases; SaMD can be used either in conjunction with other medical devices or as an interface with general-purpose software.
Medical Devices in multi-therapeutic areas
Key Regulatory Requirements for Medical Devices
21 CFR Part 801 contains labeling requirements for medical devices, including content, format, and placement.
21 CFR Part 803 contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
21 CFR Part 807 contains requirements for manufacturers to register their establishments and list the devices with the FDA.
21 CFR Part 812 contains requirements for investigational device exemption (IDE).
21 CFR Part 814 contains requirements for the premarket approval (PMA) process of medical devices with the FDA.
21 CFR Part 820 contains regulations for the quality management system that manufacturers need to follow to ensure the devices adhere to quality and safety standards.
In the EU, the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 was published on 5 May 2017 and replaced the previous Directive 98/79/EC (In Vitro Diagnostic Directive [IVDD]) with a transition period of 5 years ending in May 2022. Medical Device Regulation (EU) 2017/745 (EU MDR) became effective on 25 May 2017 repealing the existing Medical Device Directive 93/42/EEC (EU MDD) with a transition period of 4 years, including the end of extension period in May 2021.
The UK has established its own regulatory framework for medical devices separate from the EU regulations post Brexit. The UK Conformity Assessment (UKCA) mark replaced the CE mark for medical devices. However, the Medicine and Healthcare Products Regulatory Agency (MHRA) restated its existing plan to recognize the CE mark for medical devices and IVDs until 2028 and 2030, respectively. The MHRA is responsible for the regulation of medical devices in the UK. Manufacturers based outside of the UK must appoint a UK Responsible Person to act on their behalf in the UK. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted
Medical device regulations in Canada are strict guidelines established by Health Canada to ensure the safety, efficacy, and quality of medical devices available in the market. Manufacturers need to obtain a Medical Device License (MDL) to market medical devices in Canada. Health Canada uses a risk-based approach, focusing resources on higher-risk medical devices and facilitating faster approval for low-risk ones. Compliance with these regulations is crucial for patient safety and public trust in the Canadian healthcare system.
The medical device companies need to have robust and effective strategies to ensure continued adherence to dynamic regulatory compliance and keep pace with increasing complexity within scientific elements of this area.
Ensuring compliance involves complex processes, and implementation of these activities could be challenging for medical device companies.
US Medical Device Regulations
21 CFR Part 803 contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA
EU Medical Device Regulations
In the EU, the Medical Device Regulation (EU) 2017 /745 (EU MDR) came into force on 25 May 2017 repealing the existing Medical Device Directive 93/42/EEC (EU MDD) with transition period of four years including end of extension period in May 2021.
Post-Brexit Medical Device Regulations
Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, Where the single market relies on one set of rules, different rules will apply for different markets – newly defined in the EU and UK as of January 1, 2020.
Key Regulatory Requirements for Medical Devices
The medical device companies need to have robust and effective strategies in place to ensure continued adherence to dynamic regulatory compliance and keep pace with increasing complexity within scientific elements of this area
The processes necessary to ensure compliance are complex and associated implementation activities could be challenging for small and medium organizations
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Medical Information & Complaint Intake
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Safety management & Vigilance Reporting
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Addition of Roles for responsible personnel (EU)
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Regulatory Affairs & Medical Writing
- Intake of device complaints
- Intake and response to inquiries related to the medical device(s)
- Triage and flag safety reports to the safety department
End to end safety data management during clinical trials and post marketing
- Serious adverse events (SAEs)
- Unanticipated serious adverse device effects (USADEs)
- Unanticipated adverse device effects (UADEs)
- Adverse events of special interest (AESI)
- Device deficiencies
- IDE reports
- Annual safety reports
- Literature monitoring
- Trend analysis, signal detection
- Electronic Medical Device Reporting (e-MDR)/ EUDAMED
- Person Responsible for Regulatory Compliance (PRRC) as per the EU-MDR
- Authorized Representative
- Regulatory strategy design e.g., Medical device classification
- Regulatory Submissions (e.g., Technical Files/Design Dossiers, CER for CE Marking etc.)
- Expedited and periodic submissions to regulatory authorities
- Technical Documentation & Quality management systems
- Benefit-Risk Analysis and Risk Management
- Post market surveillance (PMS) plan, Clinical Evaluation and Post market clinical follow up (PMCF) plan and protocols, PMCF reports etc.
- Post market surveillance Report (PMSR)/ (Periodic Safety Update Report) PSUR
The APCER Advantage
Domain Expertise
- 100+ physicians, 90% healthcare professionals supporting product safety and vigilance requirements
- Experience and expertise in different product types, including drugs, vaccines, biologics, biosimilars, cell and gene therapy products/advanced therapy medicinal products, medical devices, and combination products
- Medical and scientific writing to support global product approval and post marketing requirements of devices
Client Focus
- Scalable and flexible operating models
- Strong governance with collaborative approach
- Outcome-driven engagements
- End-to-end vigilance, medical information, regulatory affairs, quality assurance, and medical writing activities throughout the device life cycle as per regulatory requirements
Global Presence
- Presence in the US, the UK, Europe, and Asia
- Safety reporting capabilities in 100+ countries
- Medical information coverage in 50+ countries and 30+ languages, scalable to 100+ languages
- Developing and contributing to regulatory strategies to maintain global regulatory compliance across the life cycle of devices
Quality and Compliance
- Extensive experience in supporting successful regulatory inspections and audits
- ISO accreditations received:
- ISO 9001:2015 (QMS)
- ISO 27001:2022 (ISMS)
- ISO 27701:2019 (PIMS)
