Regulatory background for medical devices in the European Union
In 2021, the EU Medical Devices Regulation (EU MDR 2017/745) became applicable after a four-year transition, replacing the EU Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). Devices being placed on the EU market for the first time must now comply with MDR requirements to obtain CE Marking, which is required to distribute medical devices in all EU Member States (though some states have additional requirements). Legacy devices (except for Class I self-certifying devices) with CE Marking certificates under the MDD or AIMDD can continue marketing their devices until their final transition deadline as long as they maintain compliance with provisional requirements according to Regulation (EU) 2023/607, which amended Article 120 of the MDR.
CE Marking Regulatory Roadmap Under the EU MDR
Classification under the MDR determines the conformity assessment procedure for your device. Medical devices are classified into Class I, IIa, IIb, or III based on their risk level, intended use, and the classification rules outlined in Annex VIII of the MDR. Under the MDR, all Class IIa, IIb, and III devices require a conformity assessment conducted by a designated Notified Body (NB) to obtain CE marking. Certain Class I devices also require Notified Body involvement if they are sterile, have a measuring function, or are reusable surgical instruments (Class Is, Class Im, Class Ir).
EU MDR Conformity Assessment Procedures for Medical Devices
All medical devices, regardless of classification, must meet the following key requirements to obtain CE Marking under the EU MDR and maintain regulatory compliance throughout the life cycle of the device:
- fulfill the General Safety and Performance Requirements (GSPRs) outlined in Annex I of the MDR.
- compile and maintain Technical Documentation in accordance with Annexes II and III that demonstrates compliance with MDR requirements.
- implement a Quality Management System (QMS) that aligns with MDR requirements, typically conforming to ISO 13485:2016.
- assign a Unique Device Identifier (UDI) to enable traceability throughout the supply chain.
- non-EU manufacturers must appoint an EU-based Authorized Representative (symbol EU REP) to represent them to regulatory authorities.
Manufacturers of Class I medical devices (excluding sterile, measuring, or reusable surgical instruments) may self-declare conformity and affix the CE Mark without the involvement of a Notified Body. However, all Class Is (sterile), Im (measuring), Ir (reusable surgical), IIa, IIb, and III devices require a Notified Body audit.
The scope and depth of the NB conformity assessment increases with the risk classification. For example, manufacturers of high-risk devices requiring pre-market clinical investigations can expect the NB to scrutinize their clinical data and verify that the investigation was conducted to ensure clinical compliance with Articles 62-82 of the MDR. Risk management files, QMS documentation, supply chain, and Clinical Evaluation Reports will be thoroughly examined. However, for low-risk devices, such as a Class I measuring device, the NB audit will be limited to conformity procedures relevant to the measuring function.
When the conformity assessment is complete, the Notified Body will issue a CE Mark Certificate (EC Certificate). The manufacturer can then affix the CE Mark, sign the Declaration of Conformity (DoC), and register the device in EUDAMED and/or with the relevant Competent Authority.
