The certification of medical devices (MD) and in vitro diagnostic devices (IVD) is a formal process confirming compliance with European Union legal requirements. This process underwent significant modernization with the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). These new regulations introduced stringent procedures concerning safety, efficacy, and quality of devices, while substantially expanding manufacturers’ obligations regarding documentation and post-market surveillance. As Professor Günter Brückner, a medical regulatory expert, notes: “MDR and IVDR are not merely regulations—they represent a new philosophy of manufacturer responsibility throughout the entire lifecycle of a device.”

Scope of Certification: Medical Devices and IVDs

Certification encompasses all MDs and IVDs, determined by their risk classification and intended clinical or diagnostic use. Medical devices are categorized into Classes I, IIa, IIb, and III, while IVDs fall into Classes A, B, C, and D. The device class dictates the type of conformity assessment procedure and the necessity for involvement of a notified body. For IVDs, performance evaluation is crucial, whereas clinical evaluation is fundamental for MDs. Innovative and critical devices, such as SARS-CoV-2 molecular tests and infusion pumps, are given particular attention.

Certification of Innovative Devices and Software (SaMD)

An innovative device leverages new technology, lacks a reference equivalent in the EU market, or extends beyond existing applications. This category includes devices with software functions, known as Software as a Medical Device (SaMD). Certifying such products necessitates not only clinical evaluation but also validation of algorithms, cybersecurity measures, and compliance with interoperability requirements. Documentation must precisely define functionalities, include risk analysis for software, and demonstrate adherence to standards like IEC 62304. Additionally, procedures for version control and system updates are mandatory.

Regulatory Strategy as a Component of Certification Planning

A regulatory strategy is a project document outlining the pathway for market authorization in accordance with MDR or IVDR requirements. It encompasses planned classification, identification of the certification route, selection of a notified body, scheduling, and strategies for risk and clinical data management. Integrating a regulatory strategy during the design phase enhances the likelihood of efficient certification and helps avoid costly modifications later. This document also serves as a foundation for communication with stakeholders, including research partners and investors.

Key Elements of the Certification Process

The certification process involves sequential stages of assessment, design, and assurance of compliance with applicable standards. Manufacturers must implement a quality system, prepare technical documentation, and demonstrate the safety and efficacy of the device. The efficiency of the entire process is measured by the time taken to obtain certification and the absence of non-conformities identified by notified bodies.

Role of the Notified Body

A notified body is an independent organization authorized to assess the conformity of devices within higher risk classes. Its responsibilities include reviewing technical documentation, auditing the quality management system, evaluating clinical data, and issuing relevant certificates. For IVDs in Classes B, C, and D, and MDs in Classes IIa, IIb, and III, involvement of a notified body is mandatory.
Wikipedia

Selecting a notified body should be preceded by an analysis of its accreditation scope (NANDO), experience with specific device groups, and availability for audits. Attention should also be paid to the quality of communication and the level of technical support offered. An inappropriate choice can lead to significant delays in the certification process.

Clinical Evaluation and Performance Evaluation in the Certification Process

Clinical evaluation and performance evaluation are fundamental assessments of a device’s safety and efficacy. They are essential for documenting that the product performs as intended. These data inform updates to technical documentation and underpin decisions made by the notified body.

  • Clinical evaluation – conducted based on clinical studies, scientific literature, and Post-Market Clinical Follow-up (PMCF) observations,
  • IVD performance evaluation – includes validation of analytical parameters: sensitivity, specificity, repeatability, and predictive values.

CE Marking

CE marking is formal evidence that a device meets the requirements specified in the EU MDR and IVDR regulations. Upon successful conformity assessment, the manufacturer issues a declaration of conformity and affixes the CE mark to the device. For Class I devices, marking can be based on the manufacturer’s self-declaration without the involvement of a notified body, simplifying the market entry process.

Importance of Post-Market Surveillance

The Post-Market Surveillance (PMS) system is a critical mechanism for verifying the safety and performance of a device after certification. Its purpose is to detect hazards, assess the effectiveness of corrective actions, and update the clinical evaluation. A well-designed PMS increases the confidence of the notified body and reduces the risk of certificate suspension.

Device Changes and Recertification

Significant changes in the design, intended use, or manufacturing process of a device may necessitate recertification. Such changes must be reported to the notified body, which will assess their impact on safety and compliance with MDR/IVDR. In practice, this entails updating technical documentation and, often, conducting a new clinical or analytical evaluation.

How Pure Clinical Can Assist with MD and IVD Certification

Pure Clinical offers comprehensive support in regulatory strategy, documentation, and liaison with notified bodies. Our services include:

  • Development and review of technical documentation,
  • Planning and execution of clinical evaluations and IVD performance studies,
  • Implementation of risk management systems in compliance with ISO 14971,
  • Preparation for audits in accordance with notified body requirements.

We collaborate with manufacturers of high-risk devices, software-based devices (SaMD), implantable devices, and molecular tests. We ensure compliance with MDR, IVDR, ISO 14155, and industry best practices.

FAQ

Does every medical device need to be certified?

No. Class I devices may be placed on the market without a notified body, provided they fully meet MDR requirements and are properly documented.

How long does device certification take?

Depending on the class and completeness of documentation, certification takes between 6 and 18 months. High-risk devices (Class III, D) require more time.

How long is a certificate issued by a notified body valid?

Certificates issued by a notified body are typically valid for up to 5 years, unless significant changes occur in the device or its intended use. A recertification audit and documentation update are required before expiration.

What is a Declaration of Conformity and who issues it?

A Declaration of Conformity is a formal document in which the manufacturer states that the device complies with MDR or IVDR. It must include the notified body number (if applicable), manufacturer details, and references to applied standards.

Can a non-EU manufacturer obtain CE certification?

Yes, but they must appoint an authorised representative in the EU responsible for regulatory compliance and maintaining technical documentation available to authorities.