The keystone to CE marking success for medical device manufacturers

It serves as a critical gateway for market entry in these regions, ensuring the delivery of devices that uphold the highest standards of safety and efficacy for end users, including patients and healthcare professionals. This mark indicates compliance with stringent EU MDR certification requirements through conformity assessment procedures conducted by the Notified Bodies – the conformity assessment bodies of the EU CE marking – are recognised beyond the EU in markets such as the United Kingdom, certain regions of Asia, and the Middle East, where many countries align with or reference EU regulations.

Under the EU MDR, manufacturers must prepare and submit a comprehensive Technical Documentation File for devices that require CE marking. The Clinical Evaluation Report (CER) is a crucial component of this documentation.

Clinical Evaluation of Medical Devices: A Critical Pillar of CE Marking Compliance

Clinical evaluation is a systematic approach to scientifically demonstrating the safety and performance of a medical device by analysing clinical data related to the device itself or a comparable equivalent. This clinical data may originate from clinical investigations conducted on the subject device, equivalent devices, or from peer-reviewed scientific literature accessible through various databases or from post-market clinical data. All this evidence should align with the relevant General Safety and Performance Requirements (GSPRs) applicable to the device, as defined in Annex I of the EU MDR 2017/745.

The gathered evidence is carefully assessed, appraised, analysed, and consolidated into a comprehensive Clinical Evaluation Report (CER) in accordance with guidance documents like Meddev 2.7/1 Rev. 4, MDCG 2020-5, MDCG 2020-26, etc. This report, along with its associated plan, called the Clinical Evaluation Plan, is a key component of the Technical Documentation File. The Technical Documentation serves as the primary dossier reviewed by the Notified Body during the process of granting EU MDR certification for CE marking compliance.

Navigating the Rigours of Clinical Evaluation Under EU MDR

With the enforcement of EU MDR 2017/745 in May 2017, the requirements for medical devices Clinical Evaluation have become more stringent, particularly in preparing evidence for the Clinical Evaluation Report (CER). Notified Bodies now meticulously document all clinical evidence submitted by manufacturers in a Clinical Evaluation Assessment Record (CEAR), a counterpart to the Technical Documentation Assessment Record (TDAR), before granting the EU MDR certificate.

For low- to medium-high-risk devices (Class I - IIb), Clinical Evaluation may rely on peer-reviewed literature and post-market clinical data rather than clinical investigation data.

For higher-risk devices, such as Class III (Heart valves, Surgical Meshes) and implantable devices (Intraocular Lens, Bone wax) —specially those entering the market for the first time—Clinical Investigation often becomes an unavoidable requirement for demonstrating safety and performance. This is particularly true when no equivalent device can be referenced through contractual agreements with equivalent device manufacturers. Defined under Article 61 of the EU MDR, this obligation places a significant financial strain on small-scale manufacturers striving for CE marking compliance, as both pathways demand substantial investment.

On the contrary, Class III devices and implantable medical device manufacturers which are legacy and already on the EU market, are not typically required to conduct Clinical Investigations unless they intend to expand the device's intended purpose or clinical indications, or if new risks are identified. However, for these legacy device manufacturers, the CER must include Post-Market Clinical Follow-up (PMCF) data as part of the clinical evidence, supplemented by peer-reviewed scientific literature.

Expert Insights

Asha Johnson, serving as the Manager for Medical Device Regulations at I3CGLOBAL, provides insightful guidance on the subject: “Achieving CE marking under the EU MDR demands strict adherence to safety and performance standards, with rigorous notified body assessments. Manufacturers often face financial and technical hurdles, particularly in defining the Clinical Evaluation pathway and its documentation. Effective planning, budgeting, and leveraging experts like Clinical Evaluators and Medical Writers are crucial. Early collaboration with seasoned consultants ensures smooth navigation of these challenges and compliance with stringent requirements.”

By implementing these strategies, manufacturers of all sizes can strengthen their preparedness for EU MDR compliance, mitigate risks, and secure a competitive edge in the EU medical devices market.

Conclusion

CE marking is essential for regulatory compliance in the EU and aligned markets, ensuring medical devices’ safety and performance. The EU MDR 2017/745 introduces stringent requirements, especially for Clinical Evaluation, necessitating a strategic approach from manufacturers.

The Clinical Evaluation Report (CER) is crucial for showcasing device safety and efficacy. Manufacturers must meticulously plan, budget, and collaborate to ensure the global delivery of innovative, safe, and effective medical devices while meeting regulatory expectations and financial challenges.

Partnering with experienced regulatory consultants like I3CGLOBAL provides valuable insights, streamlining compliance and enhancing market readiness. This proactive strategy ensures CE marking and bolsters market presence.

(This article is part of IndiaDotCom Pvt Ltd’s Consumer Connect Initiative, a paid publication programme. IDPL claims no editorial involvement and assumes no responsibility, liability or claims for any errors or omissions in the content of the article.)