The Clinical Evaluation Report is a document that assesses the safety and performance of a medical device in accordance with the European Union Medical Device Regulation (EU MDR). CER is an important technical document that summarizes the clinical evaluation of a medical device.
A Clinical Evaluation Report (CER) describes a structured appraisal and analysis of all available clinical evidence to assess the safety and performance of a medical device.
A properly structured CER is a key requirement for regulatory approval of all medical devices under MDR, the manufacturers need to understand the requirements for developing CERs under new regulation.
Overview of Device Classifications
Under EU MDR, medical devices are classified based on their intended use and inherent risk:
Class I: Low-risk devices (e.g., Manual wheelchair, Stethoscope).
Class IIa: Medium-risk devices (e.g., dental filling materials, catheter).
Class IIb: Higher-risk devices (e.g., ventilators, infusion pumps).
Class III: Highest-risk devices (e.g., pacemakers, implants).
The clinical evaluation process becomes increasingly stringent as the risk class increases
Class I Devices
For Class I devices, the CER is relatively straightforward due to the low-risk nature of these products. Manufacturers can often rely on published literature, post-market surveillance (PMS) data, and risk analysis to demonstrate compliance. Clinical data requirements are usually minimal for Class I devices.
However, additional clinical data may be needed if the device is sterile, measures something, or is reusable surgical equipment (Class Is, Im, or Ir). Equivalence justification is rarely needed, and clinical investigations are uncommon unless the device incorporates novel features or poses potential risks.
PMCF requirements are minimal and integrated into standard PMS activities. For most Class I devices, manufacturers self-certify compliance, with Notified Body involvement required only for Class Is, Im, or Ir devices. General guidance documents like MEDDEV 2.7/1 rev. 4 and MDCG 2020-6 are typically sufficient.
Class IIa Devices
Class IIa devices, being medium-risk, require a more detailed CER. Manufacturers must conduct a comprehensive literature review to demonstrate conformity and may rely on comparative data from equivalent devices if equivalence can be established per MDR Annex XIV.
Clinical investigations may occasionally be necessary, especially for innovative devices or those with limited literature support. PMCF activities are structured, requiring periodic collection of clinical data to verify ongoing compliance. The manufacturers are supposed to submit the Periodic Safety Update Report (PSUR) biannually.
Notified Body review of the CER is mandatory, with evaluations focusing on the sufficiency of clinical data and risk management. Specific guidance such as MDCG 2020-13 and MDCG 2021-6 help manufacturers address equivalence and PMCF requirements.
Class IIb Devices
For Class IIb devices, which carry higher risk, the CER must be robust and include a detailed evaluation of clinical safety and performance. Manufacturers are expected to provide comprehensive clinical data, often requiring additional PMS activities and post-market clinical follow-up (PMCF) plans.
Clinical investigations are more commonly needed to address gaps in clinical evidence, particularly for innovative or complex devices. The equivalence justification must be thorough, with detailed documentation of technical, clinical, and biological similarities between devices.
PMCF plans are detailed and focus on high-risk aspects of the device, with regular updates and annual reporting. The manufacturers are supposed to submit Periodic Safety Update Reports (PSURs) annually. Notified Bodies conduct rigorous reviews of the CER, ensuring that the device meets all regulatory requirements.
Class III Devices
Class III devices demand the most stringent CER requirements due to their high-risk nature. An exhaustive literature review and clinical investigation data are typically required. Justifying equivalence is particularly challenging for Class III devices and is subject to strict scrutiny.
Manufacturers claiming equivalence must have a contractual agreement to access the clinical data of the equivalent device unless the device falls under specific exemptions, such as being a W.E.T. (Well-Established Technology) device or a legacy device. Without this access, equivalence claims are generally not considered valid.
Clinical investigations play a crucial role in the evaluation of Class III devices. These investigations must provide substantial evidence of the device’s clinical safety and performance, following the guidelines outlined in MDR. The data gathered is critical for substantiating claims made in the CER and addressing any gaps in pre-existing evidence.
PMCF requirements are extensive and closely monitored, with manufacturers required to submit Periodic Safety Update Reports (PSURs) annually. Notified Bodies provide the highest level of scrutiny, and consultations with expert panels may be required as per MDR Article 54. Detailed guidance from MDCG 2020-5 and MDR Annex XIV is critical for preparing the CER and ensuring compliance.
Conclusion
The CER requirements under EU MDR become progressively stringent as the device risk class increases. Class I devices demand minimal documentation, while Class IIa and IIb devices require detailed evaluations, often involving equivalence and PMCF data. Class III devices face the highest level of scrutiny, frequently necessitating original clinical investigations and continuous PMCF. Understanding and addressing these distinctions is critical for manufacturers to ensure compliance and maintain market access. Leveraging guidance from MEDDEV, MDR Annexes, and MDCG documents helps streamline the CER process and align with regulatory expectations.
About the Author
Dr. Saryu Tyagi ( BDS, MBA)
Junior Consultant, I3CGlobal