If you were excited when the European Commission finally released four guidance documents covering Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8) last week (23 April 2020), you were not alone! Many of us have been waiting in anticipation for further guidance on how to handle PMCFs and were anxious for further clarification on the expectations of medical device manufacturers in this area.
Our team looked into the guidance right away in hopes that we could find some clarification for our clients. As one of our experts put it, however, on the surface this guidance is “clear as mud”. So, we dug into the new guidance and made a table to help make connections for the industry.
A few of our overall observations are listed here and check out the table below to dig deeper into each section.
• The biggest challenge we see is that because this guidance came so late in the cycle, many manufacturers have been trying to figure out how to comply and move forward for some time now. This leaves many organizations wondering how to use what they have already done and apply the guidance to their completed work.
• Additionally, there is continued ambiguity around what to do first, further proving that this is a continuous process and not a linear process. So, where do you start?
• We would have liked to see more discussion around risks and benefits regarding the guidance for legacy devices, or better direction pointing manufacturers to the best way to take ownership of this area.
• One upside we found is that there is a table for legacy devices that provides a hierarchical appendix for ranking PMCF activities, which is incredibly helpful.
Here is a tip from our pros: FDA guidance can be helpful in deciphering the expectations especially around risk-benefit analysis.
|REFERENCE||TITLE||GOOD NEWS||WATCH OUTs||NOT SURPRISING||WAS THIS REALLY NECESSARY?|
|MDCG 2020-8||Guidance on PMCF Evaluation Report Template||- The administrative section is a direct copy from the administrative section of the PMCF plan.||- You must declare if your device is novel or not; this should match your technical documentation
- You need your CND codes; if you haven’t done these yet, it is time
- The data from similar devices is required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis
|- You need to specifically define how the PMCF report impacts the CER or justify why it doesn’t
- You need to specifically define how the PMCF report impacts the risk management or justify why it doesn’t
|- You will need to include common specifications, harmonized standards and guidance documents utilized for the product; Make friends with Regulatory since they have to do that in the technical documentation|
|MDCG 2020-7||Guidance on PMCF Plan Template||- The administrative section is a direct copy from the administrative section of the PMCF plan.||- You must define explicitly where the PMCF activity need is coming from (Notified Body request, CER, Risk Management, etc.)
- You need to review case reports that may reveal off-labeling usage or misuse as part of PMCF
- You need your CND codes; if you haven’t done these yet, it is time
- The data from equivalent and similar devices are required and must include an assessment if this impacts state of the art, identifies new hazards or impacts benefit risk analysis
|- The general and specific methods and procedures PMCF activities need to be included with aim, appropriateness of methods, limitations, and endpoint/deliverable schedule
- You need to specifically define how the PMCF plan impacts the CER and risk management report or justify why it doesn’t
|- You will need to include evaluation of similar and equivalent device clinical data, including CER location in text references and how this data will be used (must match technical documentation)
- You will need to include common specifications, harmonized standards and guidance documents utilized for the product
|MDCG 2020-6||Guidance on Sufficient Clinical Evidence for Legacy Devices||- The definitions section includes terms that may not have been defined explicitly in the MDR, expands upon terms and cites where the definitions were derived (MEDDEV 2.7.1 Rev.4, etc.), especially on what “well-established technologies” can include.
- Examples of validated clinical data methodological quality assessment tools are provided
- Appendices contain modified Clinical Evaluation Plan for Legacy devices and a suggested hierarchy of clinical evidence for confirmation with relevant GSPRS under MDR, depending on the device—a lower level of clinical evidence may be justified
|- During the period of validity of the MDD/AIMDD certificates, the MDR requirements for the PMS apply from the MDR date of application-- Legacy devices are not exempted from the additional requirements in MDR concerning PMS, including PMCF
- Changes in the state of the art, new risks identified via PMS, clinical evidence of devices not sampled prior to application of MDR may not have had Notified Body scrutiny, and more detail required for indications and contraindications may change the clinical evidence needed
- Clinically relevant endpoints may be addressed through compliance to product-specific common specifications (device and sufficient clinical data-dependent)
- Clinically relevant questionnaires used to bridge gaps with MDR requirements should be scientifically sound and the guidance includes minimum considerations
|- The MDR has new requirements for equivalence and clinical data, which may reduce data available for demonstration of conformity with GSPRs
- You need to conduct a gap analysis for legacy devices per MDR GSPRs, if you have not done so
- You need to establish or update a clinical evaluation plan
|- Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report)|
|MDCG 2020-5||Guidance on Clinical Evaluation – Equivalence||- Differences in equivalence criteria (technical, biological, and clinical characteristic) between MDR and MEDDEV 2.7.1 Rev. 4 delineated and includes explanatory text.
- Example considerations of an equivalence characteristic table is included in Annex I (Note: this is not an exhaustive list)
|- Proper scientific justification for equivalence is needed --devices must have no clinically significant difference in safety and performance between the equivalent and device in-question when used under similar conditions -OR- a description of safety and clinical performance impact must be provided that must be justified.
- Clinical data that does not meet the MDR definition cannot be used as clinical evidence to conform with relevant GSPRs.
- Pre-clinical data considered for equivalence demonstration should adequately evaluate technical and biological characteristics, and whether differences would result in a significant difference in safety and clinical performance
- For products without an intended medical purpose, clinical investigation should be performed unless reliance on existing clinical data from an analogous device is justified—using demonstration of equivalence, demonstration of clinical benefit, compliance to any product-specific common specifications, and demonstrating no clinically significant difference in safety and performance between the devices.
|- The MDR biological characteristics require assessment of the final product to include factors such as processing or
- Principles in ISO 10993 standards can be adopted depending on the biological evaluation necessary for the device.
- Equivalence claims cannot be made if a manufacturer cannot demonstrate sufficient access to the presumed equivalent device
- Similar device data can be used for risk management (design hazards, clinical risks, adverse events, and acceptable occurrence rates), state of the art, clinical investigation/ PMCF study design, definition of minimum required quantified clinical benefit
|- Compliance to nonclinical common specifications relevant to device safety and performance need to be referenced depending on the device type and sufficient clinical data (these may need to be reference in the PMCF plan and PMCF report). Make friends with Regulatory since they have to do that in the technical documentation.|
Have questions? Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know.
Source: European Commission. Docs Room. Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8). Accessed 30 April 2020. https://ec.europa.eu/docsroom/?locale=en
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