MD Classify

MD Classify is an online medical device classification platform designed to support manufacturers, MedTech companies, start-ups, regulatory affairs professionals and healthcare technology developers during the preliminary assessment of medical devices under Regulation (EU) 2017/745, commonly known as the European Medical Device Regulation or EU MDR.

Available at www.mdclassify.com, the platform provides a structured and accessible way to explore the potential regulatory classification of a medical device according to the classification principles established in Annex VIII of the EU MDR.

Medical device classification is one of the first and most important stages in the EU regulatory process. The classification assigned to a product can influence its conformity assessment route, technical documentation requirements, clinical evaluation, post-market surveillance obligations and the possible involvement of a Notified Body.

Under the EU MDR, medical devices are classified as Class I, Class IIa, Class IIb or Class III according to factors such as their intended purpose, duration of use, invasiveness, anatomical location, mode of action and potential level of risk for patients and users.

MD Classify helps users navigate this assessment through a guided online questionnaire focused on the characteristics that may affect the applicable medical device risk class. The platform considers whether the product is active, invasive, implantable, surgically invasive or intended to monitor, diagnose, treat or support physiological functions.

It also evaluates factors such as the duration of patient contact, the administration or removal of substances, the monitoring of vital parameters and the potential consequences of device failure.

Based on the information entered, MD Classify applies structured classification logic to identify the EU MDR rule that may be relevant to the device and provides an immediate preliminary classification result.

The platform has been developed to make medical device regulatory classification clearer, faster and more understandable, particularly during the early stages of product development and regulatory planning.

Rather than providing only a final device class, MD Classify is designed to help users understand the reasoning behind the result and the characteristics that have influenced the preliminary assessment. This transparent approach can support internal discussions between regulatory, technical, quality and product development teams.

Users can also generate a structured PDF report summarising the preliminary medical device classification, the applicable reasoning and the information provided during the assessment. The report can be used as a starting point for internal regulatory reviews, discussions with consultants, preliminary due diligence and preparation for meetings with regulatory professionals or Notified Bodies.

MD Classify is intended for a wide range of users operating in the medical device and MedTech sectors, including established manufacturers, innovative start-ups, medical software developers, regulatory consultants, quality assurance specialists, product designers, engineers, importers, distributors and organisations evaluating regulated healthcare technologies.

The platform can be particularly valuable for companies that need an initial indication of a possible EU MDR device class before investing in a complete regulatory strategy, quality management system, clinical evaluation plan or conformity assessment procedure.

It may also support businesses evaluating new healthcare products, digital health solutions, active medical devices and other technologies that could fall within the scope of European medical device regulation.

The online medical device classification assessment is designed to be completed quickly and provides users with an immediate preliminary result. The core assessment is available online through www.mdclassify.com, allowing users to begin exploring the potential regulatory classification of a medical device without complex software installations.

MD Classify does not replace a formal regulatory assessment, legal opinion, conformity assessment or classification decision issued by a Competent Authority or Notified Body. The platform provides an informational and preliminary indication based on the data entered by the user.

Final responsibility for determining and documenting the correct classification remains with the medical device manufacturer. Complex devices, borderline products, medical software, combination products and technologies with multiple intended purposes may require further assessment by qualified regulatory affairs professionals.

By combining a guided questionnaire, EU MDR classification logic, clear explanations and an immediate downloadable report, MD Classify offers a practical starting point for organisations seeking to better understand the European medical device classification process.