Regulatory Open Forum

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.  

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.   

As I read posts on RegEx regarding the new European Medical Device Regulation (MDR) I am reminded of the lessons from the implementation of the Medical Device Directive (MDD) in the 90's.

In the early days of the MDD we got lots wrong and lacked enough guidance/clarification from the authorities. We learnt much as we worked through the transition and implementation of the MDD, clarity improved over years and refinement continued. Expectations from authorities evolved and sometimes changed. I think we are much better prepared to understand the MDR today and there are requirements that are quite clear, but there is also a lot still to interpret (significant grey areas – particularly calibrating how much is required). Where things need interpretation there are often many expert opinions, but not all expert opinions are aligned. All opinions need to be weighed and carefully considered against contrary opinions. There is sometimes more than one way to comply. Opinions are invaluable in helping to refine our thoughts and develop resilient solutions appropriate to our specific situations. We always need to look for and take account of guidance's and pay attention to the words from expert engagement organizations, Member States, competent authorities and notified bodies. With the MDR we hope for and expect much more consistency than we initially experienced under the MDD, but still we are all learning from implementing the MDR.

We need to address the requirements and navigate the grey cautiously in a balanced, informed and measured way recording our supporting justifications/rationales. Grey is good, particularly during the transition period, it supports the development of practice that is pragmatic, can be defended and is compliant. As with the MDD over the years our understanding of MDR best compliance will improve, guidance and interpretations will evolve, expectations will be refined and we will all grow more confident of the compliance of our solutions.

Thank you for engaging and sharing on RegEx it is a wonderful example of members supporting as we as a regulatory affairs commuinity work through and navigate the grey.