Regulatory Expertise for Medical Devices and IVDs
Proven regulatory advice, planning, and operational support for obtaining a CE mark in EuropeThe regulations for Medical Devices (MD) and In Vitro Diagnostics (IVD), including Combination Products and Companion Diagnostics, are changing throughout Europe. A deep understanding of the new MD and IVD Regulations (MDR and IVDR) enables us to provide customized recommendations for optimal product development to successfully obtain the CE mark.
That is why Veristat offers a team of scientific-minded regulatory experts who understand how to develop the documentation and elaboration needed to support the CE mark certification.
Regulatory Strategies for Medical Devices and IVDs
Successful MD or IVD development begins with the right road map to move forward, avoiding common pitfalls and identifying fast and cost-effective ways to successfully certify your device.
Regulatory Road Map
Developing a Road Map is critical to evaluate the regulatory and development requirements for an MD or IVD to obtain the CE mark under the new European MDR and IVDR.
The Road Map includes analysis and advice on potential regulatory, non-clinical and clinical investigations as well as on MDR/IVDR specific activities to support the certification of the device. The Road Map will also include fast pathways to certification, including the pros, cons, and risks of the alternatives and a description of the timings of the regulatory applications.
Building the Road Map
Provide regulatory assessment and recommendations regarding the MD and IVD classification
Propose a development strategy to complete with the General Safety and Performance Requirements (GSPRS), including an analysis of the available data and potential need for a clinical investigation
Schedule interactions with key Competent Authorities and Regulators - and select the right Notified Body.
Define post-marketing activities required under new Regulations
Regulatory Gap Analysis
A gap analysis is intended to examine and identify the differences between the current state of development of the MD and IVD and what the situation should be to ensure certification is obtained.
Conducting a Gap Analysis will help to improve your development process efficiency by allowing the identification of gaps, and to help define the objectives and needs that will allow your product to transition to the required end goal (e.g. enter into clinical-stage, fulfill the clinical evaluation, obtain the CE mark, etc.).
The Veristat Gap Analysis report delivers a detailed plan of the next steps and future milestones for the product to reach the foremost objective in the most efficient and successful way.
Ensuring compliance with the MDR and IVDR regulations is essential for the development of your MDs and IVDs.Our team of regulatory strategists and officers help prepare the documentation to successfully attain certification and implement the correct maintenance processes, including:
The Technical Documentation is an active document compiling all the information generated for a specific device or IVD, which will be submitted to a Notified Body (NB).
A Clinical Evaluation is the systematic process of continuously generating, collecting, analyzing, and assessing the clinical data pertaining to a Medical Device (MD) and verifying its safety and performance. This information should be compiled in the Clinical Evaluation Report (CER), which will be part of the Technical Documentation.
A Clinical Investigation is a systematic assessment involving one or more human subjects, undertaken to evaluate the safety and performance of an MD. In principle, all Class III and implantable MDs should undergo a Clinical Investigation unless an exception applies.
Our regulatory experts help design and budget the clinical investigations, with integrated cross-functional support from our in-house strategic consulting, biometrics, clinical operations, medical writing, and patient safety experts. And the same integrated teams can execute then execute the clinical investigations.
We help to establish the Risk Management Plan and the Quality Management System (QMS) needed for each MD or IVD certification under MDR and IVDR.
The performance evaluation is an assessment and analysis of data to establish or verify the scientific validity, the analytical performance, and, where applicable, the clinical performance of a device. The Performance Evaluation Report (PER) gathers and assesses all that information allowing demonstration of the clinical evidence.
We assist companies in preparing the PER by delivering a literature search and choosing those studies considered supportive. Furthermore, our team can search for an equivalent IVD to explore its path to certification.
We may also compile all the documentation and elaborate the PER for the Technical Documentation to be assessed by a Notified Body.
The Performance Study aims to establish or confirm the analytical and/or clinical performance of an IVD to achieve the manufacturer’s intended purpose.
We can help the manufacturer design the Performance Studies that support the intended purpose of the IVD.
Medical Writing for Medical Devices/IVDs
Medical device regulations can differ from pharmaceutical regulations, making compliance assurance challenging. Our scientific-minded medical writing team works closely with our regulatory experts and has significant experience preparing documents specific to medical device regulatory requirements, including:
• Clinical investigation plans and reports
• Clinical evaluation reports
• Medical device publications