Hello Tonia,
What I would recommend (for EU MDR as you indicate CER) is going to the fundamental Basic UDI-DI assignment according to your product family/device family. If you look at the regulation the Basic UDI-DI is assigned for the device/device family so for us this generally means there is a 1:1:1:1 relationship between documentation needed. Therefore, when creating the Technical Documentation, there is a Risk Management File, there is a Clinical Evaluation Plan/Report, and there is a post market surveillance plan/report all related to the same product family. Yes, there are exceptions and this may not hold true for all products, but in general the Basic UDI-DI should be the common denominator in determining how Technical Documentation are defined (which include risk management and clinical evaluation).
The basis Notified Bodies will be looking at is the Basic UDI-DI because examining the regulation this is used in many other documents like Declaration of Conformity or Safety for Clinical Safety and Performance (SSCP). When looking at the devices you listed it really comes down to product grouping into a device family/product family. Thank you for the nice detail in providing the list of the devices, but I would not presume to say whether or not those could all be grouped into one CER because this topic can be quite controversial. Your question is very valid currently though because of costs involved with Technical Documentation review including specific clinical evaluation review is increasing significantly. Rather than having a review of 5 files, indeed companies are looking to see if this can be combined into 1. I have to provide the regulatory answer is having one or multiple Clinical Evaluation files depends on many factors including regulatory appetite of the company and Notified Body perspective.
On you final question, MEDDEV 2.7/1 Rev 4 is a guidance document which has good methodology for conducting clinical evaluations - it has been sadly applied poorly (applied as requirements). And still is. Because the MEDDEV was written for the EU MDD, there is not so much clarity on if this can be used for EU MDR or not. We still use the fundamentals because again it is a decent process to follow, there are some limitations under the EU MDR, so the main comment is use caution or understand the requirements contained in the regulation. There are also some MDCG documents published discussing clinical benefit and clinical evidence, so make sure to take those into context as well.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 17-Feb-2022 14:54
From: Tonia E. Bryant
Subject: Combined CER for BP Cuffs
I have a conundrum...
Company makes blood pressures cuffs and I'm being asked if we can combine all of our cuffs into one CER. My concern is that the objective of the CER is to determine whether there is enough clinical evidence to confirm the safety and performance of the device(s) based on the intended use and associated claims.
All cuffs have essentially the same intended use, in that they are used to measure a patient's blood pressure. However, each one has a slightly different Intended purpose in how they are used in doing this function - meaning they're used with different BP machines/applications. Additionally, the patient populations are not the same across the board - some cuffs are used on adults and kids whereas some are not intended for neonates. Below are the intended use statements.
Cuff Family | Intended use statement |
ABPM Cuff | The A Cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on pediatric and adult patients. It is to be used with a Company Medical Ambulatory Blood Pressure System or with an OEM blood pressure monitoring device. |
Eclipse Cuff | The Eclipse cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on adult patients. The Cuff is designed for applications where the cuff is to be self-applied by the patient. It is to be used with a company or OEM blood pressure monitoring devices to determine blood pressure parameters on adult patients. |
APC/OPD Cuff | The All-Purpose Cuffs and One-Piece Durable Cuffs are intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. These cuffs are not intended to be used on neonates. These cuffs are intended to be used with prescription (clinical grade) blood pressure monitors or with over-the counter (home) blood pressure monitors. |
Disposable Cuff | The Disposable Blood Pressure cuff is intended to be used with non-invasive blood pressure measurement systems to determine blood pressure parameters on neonate, pediatric and adult patients. The Disposable Blood Pressure Cuff is single patient use, to assist with infection control measures. |
Orbit K Cuff | The Orbit K Blood Pressure Cuff is intended to be used with the Tango (Tango, Tango+, Tango M2) line of automated Blood Pressure monitors for cardiac stress and exercise testing. The "K" stands for Korotkoff, which indicates that these cuffs have a built-in microphone capable of detecting the "K-sounds" of the patient. |
Benefit is that we could have one CER for a common product - BP cuffs. Downside is different review times, different applications, etc.
Would appreciate thoughts. Oh, one more question...is it still acceptable to utilize MEDDEV 2.7.1/4?
Best, Tonia
------------------------------
Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
------------------------------