Technology in the medical device industry has progressed and the standards and regulations that govern the industry have been updated
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Medical Device Regulation
Extensive reform to the rules that govern the European sector represent the most disruptive changes to the industry in recent history. Since the MDR has replaced the current directive, in general, companies must comply by full application. These regulations will affect almost all products in the medical device spectrum. Our experts have the knowledge and understanding to help your organisation navigate safely through the changes.
SOME SIGNIFICANT CHANGES
The MDR has expanded the definition of a medical device, and other definitions relating to medical devices, to include a wider range of products.
Products that were not previously classified as medical devices, such as cleaning and sterilization products, enabling accessory devices, custom made devices and devices used for control or support of conception will now fall under the scope of the MDR.
The MDR has increased requirements for further and on-going clinical data before a device can be CE Marked.
The amount of clinical data necessary for each device classification is proportionate to the amount of risk associated with intended use.
High-risk devices such as class III and implantable medical devices will require more clinical data for approval.
All devices will have to be classified according to the new regulation.
Currently, marketed devices will have to receive confirmation of correct MDR classification or be reclassified.
There is no grandfathering of legacy products from MDD to MDR certification.
All currently approved devices must be re-certified in accordance with the new requirements, including all safety and performance and clinical data requirements.
Medical device manufacturers will be required to appoint a Person Responsible for Regulatory compliance(PRRC).
The PRRC will be responsible for ensuring accurate conformity assessment, maintenance and upkeep of technical documentation, post-market surveillance obligations, and ensuring reporting obligations are met.
The MDR introduces expanded traceability requirements.
All devices must be registered to EUDAMED (European Databank on Medical Devices) and issued with a unique device identification that will be associated with various tracking information and post-market vigilance reports.
The MDR introduces more stringent designation requirements for Notified Bodies.
Additionally, Notified Bodies will be tasked with new regulatory enforcement tasks.
For example, designated Notified Bodies are required to carry out periodic unannounced audits of manufacturers at least once in a five-year period.
The Quality Management System(QMS) requirements under MDR have multiple new requirements.
Some of the new requirements include installation and upkeep requirements for systems on risk management, clinical evaluations, post market surveillance, design control, safety and performance and strategies for regulatory compliance.
The MDR introduces requirements for a more rigorous post market surveillance system.
This will include plans, documentation, implementation and upkeep of all quality, performance and safety information of a device over its entire life cycle.
It also requires conclusions to be made and the relevant corrective and preventive actions to be enforced.
Periodic Safety Reports must be updated at least every two years and any incidents reporting must be submitted within 15 days (decreased from 30 days).
Key Dates for The Medical Device Regulation
APEx “A More Evolved Approach”
Understand the Change:
A comprehensive overview of the MDR’s layout and structure while gaining an understanding of the most significant changes.
Business Impact Assessment:
A global, company-wide assessment involving an initial determination of the impact of the MDR on the business.
A review of the current product portfolio from a business perspective, with identification of revenue associated with specific products and markets, including an overview of the impact that MDR CE certification has on product lines in regions worldwide.
Scope and Plan:
A plan that defines the scope, objectives and project methodologies to be used. It Includes assigning a steering committee, drafting project charters, timelines, tools and identifying resources that will be required.
A product and company wide analysis that identifies the gaps between the MDR and the current regulatory state.
An impact assessment utilising the information gathered in the gap analysis to prioritise findings based on business impact.
A detailed plan per product/ product family defining project objectives, responsibilities of each team/function in line with agreed charters and plan.
Implementation, Execution and Ongoing Assessments:
Implementation of project plans tracking key objectives with periodic updates to management.
Notified Body Assessment:
The final check for MDR compliance will be performed by your notified body.