Non-active medical devices constitute one of the most numerous groups of devices used in modern healthcare. They are utilized throughout every stage of patient care, from prevention and treatment to rehabilitation. They find application in medical facilities, specialist clinics, pharmacies, medical stores, and home environments.
According to Regulation (EU) 2017/745 (MDR), a medical device is any instrument, apparatus, appliance, software, implant, material, or other article intended by the manufacturer to be used for human beings for specific medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease and injury, or compensation for a disability. The classification of a product as a medical device is primarily determined by its intended use as specified by the manufacturer.
Non-active medical devices are those whose operation does not depend on an external or internal source of electrical energy or any energy source other than that generated directly by the human body or gravity. This means they do not use electrical energy to perform their primary medical function. This group includes, among others, dressings, bandages, syringes, needles, cannulas, catheters, ostomy products, orthopedic implants, surgical sutures, contact lenses, reusable surgical instruments, and various materials used during medical procedures.
Like all medical devices placed on the European Union market, non-active devices are subject to the requirements of Regulation (EU) 2017/745. The manufacturer is obliged to demonstrate that the device meets the relevant safety and performance requirements, has a properly conducted clinical evaluation, an implemented quality management system where required, appropriate technical documentation, and an effective post-market surveillance system. Compliance with these requirements is confirmed in the conformity assessment process, the scope of which depends on the risk class of the device.
The classification of non-active medical devices is based on the rules set out in Annex VIII of the MDR. It primarily considers the degree of risk associated with the use of the device, the intended duration of contact with the body, the site and method of application, and the degree of invasiveness. The classification of non-active medical devices includes the following categories:
· Class I - includes devices with the lowest risk level. These are primarily non-invasive devices or those with very low risk to the patient, such as hospital beds, wheelchairs, orthopedic crutches, plasters, gauze dressings, or certain sample containers.
· Class Is - covers Class I devices supplied in a sterile state, such as sterile syringes, sterile dressing kits, or sterile single-use catheters. In this case, a Notified Body assesses aspects related to ensuring sterility.
· Class Im - applies to Class I devices with a measuring function whose accuracy is significant for the safety and effectiveness of use. Examples include dosing syringes, medicine measures, or other devices enabling precise dosing.
· Class Ir – includes Clas I reusable surgical instruments, such as forceps, surgical scissors, retractors, or pincettes intended for repeated use after an appropriate cleaning, disinfection, and sterilization process. Although these are Class I devices, according to the MDR they require the involvement of a notified body regarding the assessment of aspects related to their safe reuse, specifically the processes of cleaning, disinfection, sterilization, maintenance, functional testing, and the instructions for preparing the device for reuse.
· Class IIa - includes devices with a moderate risk level, such as infusion cannulas, injection needles, short-term contact lenses, some inhalers without their own power source, or selected devices used for short-term contact with the body.
· Class IIb - includes higher-risk devices, often used long-term or in more invasive medical procedures. This group includes dialysis catheters, intraocular lenses, non-absorbable surgical sutures, certain implants, and specialized devices used during procedures.
· Class III - is the highest risk class, covering devices of critical importance for the life or health of the patient and implantable devices with the highest risk level. Examples include spinal implants, biological heart valves of animal origin, catheters coated with medicinal substances, or long-term absorbable sutures.
The device class determines the scope of the manufacturer's obligations and the conformity assessment path. For most Class I devices, the manufacturer can independently conduct the assessment and issue the EU declaration of conformity. Exceptions are Class Is, Im, and Class Ir reusable surgical instruments, for which a Notified Body must assess specific aspects. For all Class IIa, IIb, and III devices, the involvement of a Notified Body is mandatory. The Notified Body evaluates the manufacturer's quality management system and the technical documentation of the devices. After a positive conclusion, a certificate is issued which, together with the EU declaration of conformity, allows the device to be CE marked and legally placed on the EU market.
Correctly determining the device class, preparing complete technical documentation, and choosing the right conformity assessment procedure are crucial for a smooth certification process. Understanding MDR requirements at the design and development stage helps reduce the risk of delays and streamlines cooperation with the notified body.
Certification of non-active medical devices according to the MDR.
Placing a non-active medical device on the European Union market requires a conformity assessment procedure. For devices requiring a notified body, the process includes a comprehensive assessment of technical documentation, clinical evaluation, the quality management system, and fulfillment of General Safety and Performance Requirements. The aim is to confirm that the device meets all legal requirements and can be safely placed on the market.
TÜV NORD Polska is the first Polish notified body designated for the conformity assessment of medical devices under the MDR. Currently, manufacturers can also use the services of many other notified bodies designated by EU member states.
The MDR, which became applicable on May 26, 2021, replaced Directive 93/42/EEC (MDD), introducing much stricter requirements for design, assessment, and surveillance. The new regulations expanded manufacturer obligations regarding safety documentation, clinical evaluation, risk management, and post-market surveillance. At the same time, the scope of activities conducted by Notified Bodies during the certification process has been expanded.
The increased scope of required documentation and more detailed assessments conducted by notified bodies have resulted in longer certification processes, which in practice often take from several to dozens of months, depending on the device class, its complexity, and the completeness of the documentation prepared by the manufacturer.
To ensure the continuity of the supply of medical devices on the European market, transitional provisions set out in Regulation (EU) 2023/607 were introduced. They allow for the continued placement on the market of devices with certificates issued under Directive 93/42/EEC, provided that the requirements specified in the transitional regulations are met, including the timely submission of an MDR certification application to a notified body and the conclusion of a relevant agreement with it.
The deadlines for the end of the transition period depend on the risk class. The deadline is:
· May 26, 2026 - for Class III custom-made implantable devices;
· December 31, 2027 - for Class III devices and Class IIb implantable devices (excluding devices such as sutures, staples, dental fillings, orthodontic appliances, crowns, screws, wedges, plates, wires, pins, clips, and connectors);
· December 31, 2028 - for other Class IIb devices, Class IIa devices, and Class I sterile (Is), measuring (Im) and reusable (Ir) devices;
· December 31, 2028 - for Class I devices that require the involvement of a notified body under the MDR, even though they were not subject to certification under the MDD (e.g., certain medical devices composed of substances).
It should be emphasized, however, that utilizing the transitional provisions does not exempt manufacturers from the obligation to comply with selected MDR requirements. Even during the transition period, manufacturers are required, among other things, to implement the obligations arising from Article 10 of the MDR, maintain a post-market surveillance (PMS) system, monitor device safety, and report incidents in accordance with applicable regulations.
A significant limitation of the transition period is also the prohibition on making significant changes to devices covered by certificates issued under the MDD. Only non-significant changes are permitted, which in many cases require assessment by a notified body and confirmation that they do not affect the device's compliance with the conditions of the certificate.
It should also be remembered that the transitional provisions do not apply to new medical devices being placed on the European Union market for the first time. Such devices must undergo the full conformity assessment procedure in accordance with MDR requirements, regardless of their risk class.
For manufacturers planning certification, this means the necessity of starting preparations sufficiently early, properly planning the process, and completing documentation in accordance with the regulation's requirements. This allows for reducing the risk of delays, streamlining cooperation with the notified body, and efficiently conducting the certification process resulting in the acquisition of the CE marking.
Aleksandra Grzegorzewska
Auditor and Technical Expert for Medical Devices
TÜV NORD Polska
Aleksandra Grzegorzewska is a Senior Medical Device Auditor and Decision-Maker at TÜV NORD Polska. She specializes in medical device conformity assessment under the MDR frameworks, certification processes, and the qualification of borderline products.
She has extensive professional experience across both the medical device and pharmaceutical industries. Throughout her career, she has designed and supervised Quality Management Systems, managed quality control laboratories, implemented GMP and ISO standards, developed quality documentation, conducted validation activities, and performed internal and external audits.
In her current role within a Notified Body, she conducts MDR audits, reviews technical documentation, participates in certification decision-making processes, and supports manufacturers in navigating European regulatory requirements. She combines hands-on operational expertise with in-depth regulatory knowledge, focusing on a risk-based approach, patient safety, and the delivery of high-quality medical devices.