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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.

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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 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)

Our risk advisory services

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

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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).

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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.

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Our thinking

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Discover the impact of Scope 3 emissions and delve into the challenges and solutions identified in our in-depth research, commissioned by the Dutch Ministry of Infrastructure and Water Management, providing a tailored report for businesses, organizations, and academia seeking actionable insights.
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Roadmap to EU-MDR compliance and certification

Steps, considerations and timelines for manufacturers of medical devices for a timely and smooth transition to the EU-MDR.
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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.
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Explore our thinking

Get in touch

Aida Demneri

Partner
+31882880018

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