Regulatory Open Forum

Hello Marshall,

Our company develops clinical evaluation reports (CERs) and I am the evaluator of those reports, most of which I have drafted alone, but others leading a team within our group. We also have a practicing physician who I have trained and who will shortly begin to work with us under my supervision. I am a Medical Doctor who specialized in Anatomical and Clinical Pathology, which provided me with a very broad medical background and knowledge. I worked for the US FDA for six years in CDRH. Since moving to Rome, Italy during the early days of the medical devices Directives, I have been involved with helping companies comply with European medical device regulations. So, I meet the requirement of being a medical professional with knowledge of the regulations. For meeting the particular clinical specialist requirements, I ask all our client companies to have a medical specialist critically review and also sign the clinical evaluation. To date, this approach has been acceptable to the Notified Bodies reviewing our CERs. 

Just to clarify, there is a new Medical Device Regulation (REGULATION (EU) 2017/745) (MDR), but it is very likely that your Notified Body is not asking you to comply with this regulation because no one is yet able to actually work under the regulation. This is because although it has entered into force (26 May 2017), it is not yet operational. That is, companies can begin to work towards compliance, but until a Notified Body has been redesignated by a competent authority to work under the MDR (and other actions are taken), CE marking under the MDR cannot yet take place. Instead, your Notified Body is undoubtedly requiring that you follow the latest revision of the European guideline on clinical evaluations, MEDDEV 2.7/1 Rev. 4, issued in June 2016. Before that date, your company was surely following Rev. 3 of that guideline. Although the competent authority who was the principal author of MEDDEV 2.7/1 Rev. 4 has stated that the guidance is not a regulation and therefore Notified Bodies should not treat it as such, some competent authorities do not have the same view and are pushing Notified Bodies to require that MEDDEV 2.7/1 Rev. 4 be followed.

Section 6.4 of MEDDEV 2.7/1 Rev. 4, "Who should perform the clinical evaluation?", states that with respect to the particular device under evaluation, evaluators should have knowledge of: the device technology and its application and diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty). Following this particular part of the guidance will be extremely difficult or impossible for many medical device companies. Even Notified Bodies are facing significant difficulties in contracting with a sufficient number of medical specialists for CER review purposes. Therefore, many companies will follow the last sentence of guidance in Section 6.4, which is: "There may be circumstances where the level of evaluator expertise may be less or different; this should be documented and duly justified."

I would be happy to discuss this further if you wish to do so.

Hello Marshall,

Our company develops clinical evaluation reports (CERs) and I am the evaluator of those reports, most of which I have drafted alone, but others leading a team within our group. We also have a practicing physician who I have trained and who will shortly begin to work with us under my supervision. I am a Medical Doctor who specialized in Anatomical and Clinical Pathology, which provided me with a very broad medical background and knowledge. I worked for the US FDA for six years in CDRH. Since moving to Rome, Italy during the early days of the medical devices Directives, I have been involved with helping companies comply with European medical device regulations. So, I meet the requirement of being a medical professional with knowledge of the regulations. For meeting the particular clinical specialist requirements, I ask all our client companies to have a medical specialist critically review and also sign the clinical evaluation. To date, this approach has been acceptable to the Notified Bodies reviewing our CERs. 

Just to clarify, there is a new Medical Device Regulation (REGULATION (EU) 2017/745) (MDR), but it is very likely that your Notified Body is not asking you to comply with this regulation because no one is yet able to actually work under the regulation. This is because although it has entered into force (26 May 2017), it is not yet operational. That is, companies can begin to work towards compliance, but until a Notified Body has been redesignated by a competent authority to work under the MDR (and other actions are taken), CE marking under the MDR cannot yet take place. Instead, your Notified Body is undoubtedly requiring that you follow the latest revision of the European guideline on clinical evaluations, MEDDEV 2.7/1 Rev. 4, issued in June 2016. Before that date, your company was surely following Rev. 3 of that guideline. Although the competent authority who was the principal author of MEDDEV 2.7/1 Rev. 4 has stated that the guidance is not a regulation and therefore Notified Bodies should not treat it as such, some competent authorities do not have the same view and are pushing Notified Bodies to require that MEDDEV 2.7/1 Rev. 4 be followed.

Section 6.4 of MEDDEV 2.7/1 Rev. 4, "Who should perform the clinical evaluation?", states that with respect to the particular device under evaluation, evaluators should have knowledge of: the device technology and its application and diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty). Following this particular part of the guidance will be extremely difficult or impossible for many medical device companies. Even Notified Bodies are facing significant difficulties in contracting with a sufficient number of medical specialists for CER review purposes. Therefore, many companies will follow the last sentence of guidance in Section 6.4, which is: "There may be circumstances where the level of evaluator expertise may be less or different; this should be documented and duly justified."

I would be happy to discuss this further if you wish to do so.

Hello Marshall,

Our company develops clinical evaluation reports (CERs) and I am the evaluator of those reports, most of which I have drafted alone, but others leading a team within our group. We also have a practicing physician who I have trained and who will shortly begin to work with us under my supervision. I am a Medical Doctor who specialized in Anatomical and Clinical Pathology, which provided me with a very broad medical background and knowledge. I worked for the US FDA for six years in CDRH. Since moving to Rome, Italy during the early days of the medical devices Directives, I have been involved with helping companies comply with European medical device regulations. So, I meet the requirement of being a medical professional with knowledge of the regulations. For meeting the particular clinical specialist requirements, I ask all our client companies to have a medical specialist critically review and also sign the clinical evaluation. To date, this approach has been acceptable to the Notified Bodies reviewing our CERs. 

Just to clarify, there is a new Medical Device Regulation (REGULATION (EU) 2017/745) (MDR), but it is very likely that your Notified Body is not asking you to comply with this regulation because no one is yet able to actually work under the regulation. This is because although it has entered into force (26 May 2017), it is not yet operational. That is, companies can begin to work towards compliance, but until a Notified Body has been redesignated by a competent authority to work under the MDR (and other actions are taken), CE marking under the MDR cannot yet take place. Instead, your Notified Body is undoubtedly requiring that you follow the latest revision of the European guideline on clinical evaluations, MEDDEV 2.7/1 Rev. 4, issued in June 2016. Before that date, your company was surely following Rev. 3 of that guideline. Although the competent authority who was the principal author of MEDDEV 2.7/1 Rev. 4 has stated that the guidance is not a regulation and therefore Notified Bodies should not treat it as such, some competent authorities do not have the same view and are pushing Notified Bodies to require that MEDDEV 2.7/1 Rev. 4 be followed.

Section 6.4 of MEDDEV 2.7/1 Rev. 4, "Who should perform the clinical evaluation?", states that with respect to the particular device under evaluation, evaluators should have knowledge of: the device technology and its application and diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty). Following this particular part of the guidance will be extremely difficult or impossible for many medical device companies. Even Notified Bodies are facing significant difficulties in contracting with a sufficient number of medical specialists for CER review purposes. Therefore, many companies will follow the last sentence of guidance in Section 6.4, which is: "There may be circumstances where the level of evaluator expertise may be less or different; this should be documented and duly justified."

I would be happy to discuss this further if you wish to do so.