your device class" width="1600" height="900" />Explore the crucial steps for obtaining CE approval for your medical device under MDR. Learn more about the key aspects of conformity assessment tailored to each device class.
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Over the past years, the QbD Group has amassed extensive experience in guiding manufacturers towards CE approval for their medical devices, now including compliance under MDR.
This challenging process necessitates a deep understanding of the regulations and how notified bodies inspect the conformity of submitted dossiers. We often encounter questions about possible workarounds, particularly whether all this work is necessary when a manufacturer is ‘only’ placing a Class I or Class IIa medical device on the market.
In this blog post, we aim to dispel the misconception that obtaining CE approval for lower-class medical devices is easier and quicker. We will summarize the most important aspects of conformity assessment for each device class to elucidate the process.
As indicated on the website of the European Commission, a medical device can only be placed on the EU market if the manufacturer can show that it meets all the applicable requirements. A conformity assessment should be carried out before the product can be sold.
This means that the medical device should be demonstrated to meet all the legislative requirements, including testing, inspection, and certifications, so it ensures the confidence of consumers, public authorities, and manufacturers regarding the conformity of the product.
In practice, the manufacturer carries out the conformity assessment as described in the legislation (MDR in the case of Medical Devices) and draws up a Declaration of Conformity (DoC) containing:
With the latest regulation on medical devices, REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017, significant changes to the conformity assessment procedure have been introduced (Annex IX to XI), including the requirement that every medical device must include sufficient clinical evidence to demonstrate compliance.
Different types of conformity assessment procedures exist, and the one you need to follow depends on your medical device’s classification. Refer to Annex IX for assessments based on a quality management system and technical documentation; to Annex X for type examination assessments; and to Annex XI for product conformity testing assessments.
In exceptional cases, and upon request, manufacturers may be exempted from the conformity assessment procedure. However, this is only possible if it’s previously verified that the medical device will benefit public health and enhance patient safety and/or health.
For Class I devices (except for Class Im (measuring), Class Is (sterile), and Class Ir (reusable)), the manufacturer can opt for the so-called ‘self-certification’ route. To declare conformity of the device, the manufacturer issues the EU Declaration of Conformity according to Article 19 of the MDR, after fulfilling the general obligations listed in Article 10.
The Technical Documentation should be maintained in accordance with Annexes II and III. However, Class Im, Is, and Ir devices require a limited Quality Management System (QMS) to control production (as per Annex XI, part A) or to control special characteristics (as per Annex IX, Chapters I and III). Notified Bodies are involved in assessing this QMS.
Class II medical devices are further classified as Class IIa or Class IIb. Class IIb devices are categorized into implantable devices, or active devices intended to remove or administer medicinal substances, and those not included in the aforementioned categories.
Exempt from this classification are custom-made devices and investigational devices. Also exempt are sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, and connectors. Special requirements exist for these exempted devices.
In general, the MDR provides several options for conducting conformity assessments: either by assessing the Technical Documentation of a representative sample of the devices or by carrying out tests to confirm the conformity of the devices. The distinction is that for Class IIa devices, a Notified Body assesses at least one representative device per category, whereas for Class IIb devices, the assessment is done per generic device group.
Conformity assessment for Class IIa devices can be conducted under Annex IX, requiring a full QMS and an audit by the Notified Bodies, along with their assessment of the Technical Documentation. Alternatively, the manufacturer can opt for the assessment under Annex XI for product control, coupled with the required Technical Documentation as per Annexes II and III, and an audit by the Notified Bodies of the Production Quality Assurance to ensure the capability to produce and test the device.
For Class IIb medical devices, whether implantable or non-implantable, the routes for conformity assessment to consider are:
For Class IIb medical devices that are active and intended to administer or remove a medicinal substance, there are also three types of conformity assessments to choose from:
