Medical device regulatory analysis

If you wish to market your product within the EEA (European Economic Area), you need to comply with specific requirements as set out in European directives and regulations. For some products it may be challenging to differentiate if they should properly be classified as medicinal product, medical device or even dietary supplement or cosmetic. Eventually, such borderline product must be assigned into a specific category and fall within the scope of applicable set of legislation.

Medical devices (MDs) fall within Regulation (EU) 2017/745 (MDR) and medicinal products for human use are covered by Directive 2001/83/EC (MPD). The qualification of product is crucial for further assessment of project timelines, the extent of data and estimated costs of introduction to the market.

Analysis of regulatory requirements for medical device can answer the following:

• if the product meets the definition of medical device under MDR and can be registered as such;
• what risk class can be assigned to the device;
• scope of clinical/non-clinical data for demonstration of compliance with General Safety and Performance Requirements (GSPRs);
• usefulness of public source data and literature evidence in MD certification process;
• requirements for technical documentation;
• registration strategy for MD used in combination with medicinal product;
• qualification of borderline product, advantages and disadvantages of each regulatory path;
• other questions related to MDR implementation and product classification.

The analysis may constitute a comprehensive assessment of the applicability of: desired product category, product design and intended purpose, required documentation, clinical evaluation plan and completion (including the need for further investigations), estimation of costs and timelines for market introduction and other case-specific aspects. It can also be a short problem-focused assessment for particular goals, according to individual client needs.

Why SciencePharma?

SciencePharma offers comprehensive services in product development, registration process and maintenance of medicinal products and medical devices. We can step in at every stage of the product’s lifecycle and provide suitable solutions, regardless if you are scarcely planning a development of specific device, or you need to deal with transition into the new EU legislation with your legacy device.

Thanks to our 15 years of presence in pharma industry and cooperation with private sector pharmaceutical companies and public research institutions, SciencePharma holds invaluable experience and practical knowledge to support our clients. We have prepared over 200 scientific opinions/advices concerning regulatory aspects, including over 40 opinions on medical devices. In the projects implemented so far, our recommendations have been recognized by notified bodies and competent authorities within EU. Our team constantly improves their knowledge by participation in internal and external trainings, and being up-to-date with regulatory obligations and current state-of-the-art.

Benefits of cooperation with us

Clients collaborating with SciencePharma can reap the benefits of our wide experience, transparency and creativity for seeking innovative solutions. Our interdisciplinary team incorporates medical, quality and regulatory insight to offer made-to-measure solutions for our Clients.

Finding the optimal regulatory pathway and specifying the scope of required clinical and non-clinical data for your product is crucial for a smooth and successful product registration process, without unnecessary downtime and delays during the procedure. We ensure timely preparation of detailed analysis, which provides specific answers to troublesome issues regarding medical device development, certification process and/or post-market surveillance. Based on the initial inquiry of the customer, our team prepares preliminary assessment of the scope of needed services with total cost and timelines. If you choose to work with us, we will be glad to answer all your questions and prepare a solution tailored for you.

Medical devices or medicinal products?

Want to know more about distinguishing between medical devices and medicinal products? – read about borderline product classification under MDR.

If you are interested in cooperation, please contact us. Our experts will be glad to answer all your questions regarding medical devices and more.

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