Clinical evaluation is a critical component of the Medical Device Regulation (MDR) (EU) 2017/745. It involves the assessment and analysis of all clinical data to verify the clinical safety and performance of a medical device. MDR updated the requirements for clinical evaluation and emphasizes careful planning in early phase of development. In some cases, there is a need for pre- or post-market clinical investigations.
In addition to the MDR itself, relevant MEDDEV/MDCG guidance documents and ISO standards give guidance about conducting and documenting clinical evaluations and investigations. ISO standard 14155 ‘Clinical investigation of medical devices for human subjects — Good clinical practice’ is under update. Using ISO 14155:2020 helps to ensure compliance with good clinical practice (GCP) and regulatory expectations of the MDR. Additionally, ISO/CD 18969 ‘Clinical evaluation of medical devices’ is under development.
We are excited to invite you to our upcoming webinar on these topics. In this webinar you will learn if your medical device is in a need of clinical investigations. You will also learn about properly documenting a clinical evaluation, including how to compile a clinical evaluation plan and a clinical evaluation report according to the requirements in the MDR.
In the webinar we will also give practical tips for ensuring that your clinical investigation meets the needed GCP requirements and none of the essential elements are forgotten.
Who Should Attend:
- Medical device manufacturers
- Scientists involved in medical device product development
- Medical device regulatory affairs professionals
- Clinical project managers for medical devices
- Medical device quality assurance specialists
- Anyone involved in EU MDR compliance and clinical investigations
Why attend:
- To learn how to conduct and document an MDR compliant clinical evaluation
- To get confirmation if your device’s clinical evaluation plan or report needs to be updated
- To learn when pre- or post-market clinical investigations are needed and how to tell if your device needs an investigation
- If you are planning a clinical investigation, you will learn which elements to pay attention to
- To get practical tips on ensuring compliance of your clinical investigation with MDR requirements
The live session of the webinar was fully booked, showing how important and relevant this topic is. Many participants found the webinar useful and informative:
“Very complete and clear explanation”
“It gave a very good overview of what needs to be done”
“In a short time, all the material was presented in a concise format. Thank you.”
“Very good webinar, especially strong focus on the clinical investigation”
Speakers:
Essi Sarkkinen
Director, Clinical Research and Medical Device
Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit, which consists of experts in Finland and the Baltic region. In March 2025, she was appointed Director of Clinical Research and Medical Device.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
Satu Koskimies
Project Manager, Clinical Operations
Since 2001, Satu Koskimies has accumulated more than two decades of experience in clinical project management and coordination, medical writing and regulatory intelligence. Satu has worked at Medfiles since 2022, now as Clinical Project Manager. Satu has a M.Sc. in biology, and she is also a practical paediatric nurse and a seasoned clinical trial professional.
At Medfiles, she is involved with both medicinal products and medical devices, with a history of previously working with various CROs and biotech and pharma companies. Actively participating in the creation and implementation of robust quality management systems, preparing new operating procedures and enhancing high-quality performance in clinical research activities have been her favourite assignments during her career.
Emma Talvitie
Regulatory Affairs Expert, Medical Devices and IVDs
Emma Talvitie is a medical device and in vitro diagnostic (IVD) regulatory affairs professional with a Master of Science (Tech.) degree in biotechnology, who has over 4 years of professional experience in MD and IVD regulatory affairs. Emma has a strong background in IVD regulatory affairs and assay development. During her studies she focused on assay development, especially in molecular diagnostics and immunoassays. She started her career by updating the IVDD compliant technical documentation of an IVD analyser to be compliant with the IVDR. She has also been responsible for planning, executing, data analysis and reporting of IVD assay verification and validation studies and contributed to writing and reviewing IVDR and FDA 510(k) documentation for IVD assays.
Since April 2023, as a Regulatory Affairs Expert at Medfiles, Emma has worked in varying projects helping clients with regulatory issues and compiling technical documentation for multiple medical devices and IVDs. Emma is exited about contributing to the development of innovative, high-quality devices that meet both regulatory requirements and user needs.
Medical device clinical evaluation and clinical investigation services
At Medfiles, we support you throughout the medical device lifecycle – from clinical evaluation and clinical investigations to regulatory compliance and post-market activities. Our expertise covers both medical device and IVD studies at every stage: from study design, regulatory and ethical approvals, to conduct, monitoring and reporting. With over a decade of hands-on experience in clinical evaluation and clinical studies, we help you manage your projects efficiently.
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