How MDCG guidance aids conformity with the MDR clinical requirements
Preparing a Clinical Evaluation under the EU Medical Device Regulation (EU MDR) can be a daunting task. The EU MDR (Regulation (EU) 2017/745) has shifted the expectations for these clinical evaluations, requiring manufacturers to provide more specific, device-relevant clinical data, and placing a much greater emphasis on the analysis and justification for what is presented and used to evaluate a device’s performance and safety profile. As such, these documents can quickly become complex without the right tools and references.
Fortunately, the Medical Device Coordination Group (MDCG) has published a suite of guidance documents that help manufacturers interpret MDR requirements and apply them consistently[1]. While not legally binding, they reflect the expectations of Notified Bodies and the European Commission. When used effectively, the MDCG guidance can significantly improve the clarity, structure, and regulatory defensibility of Clinical Evaluation documentation. Whether you are drafting a Clinical Evaluation Plan (CEP), a Clinical Evaluation Report (CER), or just wondering how you can ensure you have an appropriate level of clinical evidence for your device, these resources can help demonstrate MDR conformity in a well-reasoned, compliant manner.
Let’s take a specific look at the 4 most-effective MDCG guidance documents that can support your Clinical Evaluation work.
MDCG 2020-13: Clinical evaluation assessment report template
MDCG 2020-13 provides a template for the Clinical Evaluation Assessment Report (CEAR), the document a Notified Body prepares when reviewing your Clinical Evaluation. In other words, it shows you exactly how your work will be assessed.
For manufacturers, this guidance is incredibly valuable as, while the CEAR itself is created by the Notified Body, the structure and questions it contains can be used as a reverse-engineered blueprint when designing your own CEP and CER templates.
MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices
Not every medical device is required to have direct clinical evidence that has been conducted in the relevant patient population in order to demonstrate conformity with the EU MDR. For devices that: have been previously placed on the EU market under the EU MDD; have been used safely and effectively for decades; have extensive and appropriate PMS data; have a simple and consistent design; and are well-understood and characterised within their medical field, the collection of direct clinical evidence is often not considered feasible. These devices are known as legacy devices. The MDCG 2020-6 explains how manufacturers can demonstrate sufficient clinical evidence for such devices without having existing clinical data and without generating new clinical data, provided they meet certain criteria. This guidance is especially relevant for simple, longstanding technologies such as forceps, ice packs, surgical scissors, basic wound dressings, or hand-held examination instruments.
MDCG 2020-5: Guidance on clinical evaluation – Equivalence
Under the previous MDD regulation, equivalence was a widely used approach to justify safety and performance when direct clinical data was limited. The MDR however, tightened the requirements for claiming equivalence, in terms of the more stringent application of technical, biological, and clinical characteristics, and as a result, equivalence is no longer the powerful justification tool it once was. The MDCG 2020-5 explains when equivalence can still be used legitimately and how to document it.
Today, equivalence is applicable primarily in two scenarios:
- Bringing an existing product in-house, provided access to technical documentation is guaranteed
- For medical device software (MDSW) relying on clinical data from a previous software version, providing functionality, performance, usability, and associated risks that remain consistent.
MDCG 2020-1: Clinical and performance evaluation of medical device software
Medical device software (MDSW) presents unique challenges under the MDR. Data presented within a Clinical Evaluation Report, as per the MDCG 2020-1 document, must demonstrate three things, clinical performance, scientific validity, and technical performance. These three things ensure that: 1). the device performance and safety profile are demonstrable via clinical evidence; 2), the device is clinically valid and the principles by which it functions are appropriately established, as often demonstrable via the State of the Art Analysis; and 3). that the device has been verified and validated with respect to its technical performance and that it can accurately and reliably produce its intended output, as often demonstrable through pre-clinical evidence.
Using MDCG guidance to strengthen your Clinical Evaluation strategy
When writing Clinical Evaluation documents under the MDR, it’s essential to not only demonstrate that sufficient evidence exists, but also that you have interpreted and applied regulatory expectations correctly. Using MDCG guidance documents strategically helps you:
- structure your documentation more clearly
- anticipate Notified Body review questions
- apply consistent, defensible methodologies
- reduce unnecessary clinical evidence generation
- produce Clinical Evaluations that withstand regulatory scrutiny
MDCG guidance documents are invaluable resources for any manufacturer preparing Clinical Evaluation documentation under the EU MDR. They provide clarity where the regulation is broad, offer structure where methodology is needed, and help ensure your approach aligns with regulatory expectations. Whether you are working with legacy devices, assessing software, or simply improving your internal templates, these documents serve as a practical foundation for achieving MDR compliance.
Relying on an expert regulatory consultancy can make this process far smoother. Experienced consultants not only help interpret MDCG guidance correctly but also ensure your Clinical Evaluation is well-structured, defensible, and aligned with current MDR expectations, saving time, avoiding common pitfalls, and increasing confidence in your conformity assessment outcomes.
Ready to improve your Clinical Evaluation and ensure MDR compliance? Contact us at hello@imedconsultancy.com to find out how we can support your medical device journey.
