Medical Devices & In Vitro Diagnostics has been saved
Solution
Medical Devices & In Vitro Diagnostics
Demonstrating conformity with the European Regulations requires specialized quality and regulatory knowledge and experience
We provide a wide range of strategic and hands-on quality and regulatory support services in Device Lifecycle Support, Quality and Regulatory Automation and Training.
Your challenge
The process of obtaining CE marking for medical devices and in vitro diagnostics (IVDs) can be long and complex. There is no one-size-fits-all-solution for the implementation of the medical device and IVD regulations. Endless variations exist between device types, manufacturers and supply chain process interactions.
Dedicated regulatory knowledge and practical experience are essential to overcome the regulatory hurdles faced by manufacturers and to design and implement the best possible solution for a device and the applicable lifecycle processes.
Why Deloitte
We assist manufacturers of medical devices and IVDs with a wide range of quality and regulatory (Q&R) support services throughout the entire device lifecycle.
We have the right expertise for defining optimal strategies for placing and maintaining medical devices and IVDs on the EU market.
We are specialized in Quality and Regulatory Compliance for Medical Devices and IVDs, in particular Regulation (EU) 2017/745 (EU-MDR) and Regulation (EU) 2017/746 (EU-IVDR).
We assist manufacturers and other economic operators through compliance readiness and maturity assessments and by delivering cross-functional remediation and transformation projects.
Our global network accelerates the delivery of our Q&R services world-wide.
Our solution
We provide a wide range of strategic and hands-on quality and regulatory (Q&R) support services in three main areas:
Device lifecycle support
From regulatory strategy development to product realization, market authorization & registration and post-market surveillance
- Design controls & risk management
- Clinical evaluation & investigation
- Clinical evidence, performance evaluation and performance studies
- Supplier controls & contract development
- Labelling & Instructions for use (IFU)
- Technical documentation (TD) setup & assessment
- Quality management system (QMS) setup & assessment
- Computer system validation (CSV)
- Data privacy and cyber safety
- Unique device identification (UDI) & EUDAMED registration
- Post-market surveillance (PMS) & vigilance
Quality and Regulatory Automation
To automate regulatory intelligence, improve quality and regulatory information management and to speed regulatory submissions.
More and more manufacturers are considering technology-enabled solutions to fulfil the increased quality and regulatory demands. We support them in the selection, implementation and optimisation of the right information management solutions such as Regulatory Information Management Systems (RIMS) and electronic Quality Management Systems (eQMS).
Training
To establish appropriate understanding of EU-MDR and EU-IVDR, the impact and benefits for all levels within your organisation, and to leverage best practice solutions seen in the industry.
Our focus areas
We assist the medical device and IVD industry with delivering regulatory compliance and transformation projects covering a wide range of medical device and IVD types such as:
- Digital / Connected / Software Medical Devices
- Combination Products/ Drug-Device Combinations (DDCs)
- Implantable Medical Devices
- Substance-based Medical Devices
- In Vitro Diagnostics (IVDs)/ Companion Diagnostics (CDx)
Related articles
Handreiking helpt bij certificeringsproces MDR en IVDR
De Europese Verordening voor Medische Hulpmiddelen (MDR) en In-Vitro Diagnostiek (IVDR) hebben als doel om de veiligheid van medische hulpmiddelen te waarborgen. Een fabrikant mag een medisch hulpmiddel pas op de markt brengen als dit voldoet aan de wettelijke eisen. Wordt aan deze eisen voldaan, dan geeft een Notified Body een certificaat af. Maar hoe werkt dat proces precies? In opdracht van VWS ontwikkelde Deloitte een handreiking om je op weg te helpen. Deze handreiking is met name gericht op start-ups en het MKB die het certificeringsproces nog moeten doorlopen of die momenteel zijn begonnen met de (her)certificering.
Navigating EUDAMED implementation
Although (full) EUDAMED go-live might seem distant, early preparation is key to success. Manufacturers face the challenging job of carefully improving their processes, preparing the organization, their technology, and information landscape. This involves a lot of effort and time, especially because it is important to take a thorough and proactive approach to make sure that you can successfully comply with EUDAMED requirements. Learn more on EUDAMED modules, timelines and how to start your compliance journey.
Mastering QMS Transformation
Medical device manufacturers should future-proof their Quality Management System to better navigate the shifting tides of the regulatory and market landscape. Learn more about the characteristics of an evolving QMS and explore how the POTI approach facilitates your QMS transformation program.
Roadmap to EU-MDR compliance and certification
The EU-MDR is a significant upgrade to the previous regulatory framework and aims to ensure the highest possible safety and effectiveness of medical devices. Medical devices may now be placed on the European market only if they comply with the applicable requirements as laid down in the EU-MDR. What does this mean for manufacturers and their roadmap to EU-MDR compliance and certification?
European Medical Device Regulation
The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical devices before and after these are brought to the EU market. There is no one-size-fits-all-solution for the implementation of the medical device regulations.
Is your medical device cybersecure enough?
Manufacturers of digital medical devices, medical devices that incorporate electronic programmable systems (PEMS) and software that are medical devices, will have full responsibility to establish and maintain ‘security by design’ with the introduction of the Medical Device Regulation (MDR).
When digital tech becomes a medical device
Wearables and other digital tech have enormous potential for enabling personalized and preventative healthcare but their adoption into the clinical environment has been relatively slow due to data quality, privacy and cyber safety concerns. The industry should embrace the new EU regulations for medical devices to address these concerns and to unlock the full potential of their products for healthcare.
AI in Healthcare: opportunity or threat?
Artificial Intelligence has the potential to revolutionise healthcare and wider dimensions of wellness, but the ethical implications are becoming increasingly complex. Where decisions are often sensitive and impact people’s lives directly, what can and should you leave to self-learning algorithms?
European In Vitro Diagnostic Medical Device Regulation (EU-IVDR)
The EU-IVDR came into effect as of May 2022 and has replaced the In Vitro Diagnostics Medical Device Directive 98/790/EC (IVDD), laying the basis for safe IVDs market entry and maintenance. However, the process of obtaining CE marking for IVDs can be long and complex.
COVID-19: Shaping the future regulation of emergency medical equipment supply
The COVID-19 pandemic has disrupted everyone’s daily lives and touched every industry across the world. The demand for appropriate medical devices and equipment quickly outstripped supply, leading to critical shortages, particularly of ventilators and personal protective equipment (PPE). Consequently, traditional and novel medical equipment manufacturers have pivoted many of their activities to meet this demand. At the same time, international and national regulators have had to adapt their approach to granting market approval. These changes have implications for the future of medical device regulation.
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