Regulatory Open Forum

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

Thank you for always ranting in this forum. Knowing that I am not the only one that loves to rant about the current medical device regulatory landscape (in particular in Europe) is a huge comfort to me ;) ! 

Now with respect to the issue of CER writers … .

First of all and anecdotal : I remember first reading the MEDDEV Rev 4 document just after it was published in June 2016. Coincidentally, the campaign for that year's US presidential elections was in full swing and it struck me that (at least formally) the requirements for this function were far less than those for writing a CER about, say, many basic and familiar medical devices like syringes or other injection or infusion devices. Indeed, the requirements from MEDDEV Rev 4 for the authors of CERs seemed to be thought up by a forum with a way too academic/bureaucratic mindset and that could never be put to practice in the real world. 

Yet, I do happen to know of at least one individual that has been writing CERs for many, many years (well over a decade). It is someone that I highly respect. He has a double degree (one in medicine and on in electrical engineering) and worked for many years at a leading Notified Body in Germany, before becoming a consultant. Many, many years ago he was already aware of the increasing importance of CERs both for manufacturers and for Notified Bodies (that might lose their designation if they would not have adequate skills to review CERs). He retired just a few years back, but I do not know whether he still occasionally comes to the rescue of manufacturers or Notified Bodies for writing or reviewing CERs. 

Also, I happen to know a local (i.e., based in Lausanne, Switzerland) consulting company that has been writing CERs for a great many years now. Their founders, too, had properly anticipated the increase in requirements for CERs and the business opportunity it represented to them. And it seems very likely that other consulting organizations have done similarly. 

Also, I recently attended a local meeting of Swiss Medtech (an organization representing the Swiss medical device industry) and asked about the feedback the attendees had received from their Notified Bodies regarding the authors of their CERs. It seems currently acceptable (defensible) practice that a knowledgeable person with a product engineering, quality, or regulatory function writes the report, but that it is reviewed (and signed) by someone with the appropriate medical background. It now remains to be seen how the acceptance of this practice evolves over time as CERs keep gaining importance under the EU MDR (mutatis mutandis the EU IVDR). Yet, manufacturers and Notified Bodies alike must keep finding mutually acceptable practices for CERs as to assure an implementation of the requirements that is addressing the device's clinical safety and performance in a practicable goal-oriented manner, not as a bureaucratic exercise. 

With kindest regards,

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

Thank you for always ranting in this forum. Knowing that I am not the only one that loves to rant about the current medical device regulatory landscape (in particular in Europe) is a huge comfort to me ;) ! 

Now with respect to the issue of CER writers … .

First of all and anecdotal : I remember first reading the MEDDEV Rev 4 document just after it was published in June 2016. Coincidentally, the campaign for that year's US presidential elections was in full swing and it struck me that (at least formally) the requirements for this function were far less than those for writing a CER about, say, many basic and familiar medical devices like syringes or other injection or infusion devices. Indeed, the requirements from MEDDEV Rev 4 for the authors of CERs seemed to be thought up by a forum with a way too academic/bureaucratic mindset and that could never be put to practice in the real world. 

Yet, I do happen to know of at least one individual that has been writing CERs for many, many years (well over a decade). It is someone that I highly respect. He has a double degree (one in medicine and on in electrical engineering) and worked for many years at a leading Notified Body in Germany, before becoming a consultant. Many, many years ago he was already aware of the increasing importance of CERs both for manufacturers and for Notified Bodies (that might lose their designation if they would not have adequate skills to review CERs). He retired just a few years back, but I do not know whether he still occasionally comes to the rescue of manufacturers or Notified Bodies for writing or reviewing CERs. 

Also, I happen to know a local (i.e., based in Lausanne, Switzerland) consulting company that has been writing CERs for a great many years now. Their founders, too, had properly anticipated the increase in requirements for CERs and the business opportunity it represented to them. And it seems very likely that other consulting organizations have done similarly. 

Also, I recently attended a local meeting of Swiss Medtech (an organization representing the Swiss medical device industry) and asked about the feedback the attendees had received from their Notified Bodies regarding the authors of their CERs. It seems currently acceptable (defensible) practice that a knowledgeable person with a product engineering, quality, or regulatory function writes the report, but that it is reviewed (and signed) by someone with the appropriate medical background. It now remains to be seen how the acceptance of this practice evolves over time as CERs keep gaining importance under the EU MDR (mutatis mutandis the EU IVDR). Yet, manufacturers and Notified Bodies alike must keep finding mutually acceptable practices for CERs as to assure an implementation of the requirements that is addressing the device's clinical safety and performance in a practicable goal-oriented manner, not as a bureaucratic exercise. 

With kindest regards,

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

Thank you for always ranting in this forum. Knowing that I am not the only one that loves to rant about the current medical device regulatory landscape (in particular in Europe) is a huge comfort to me ;) ! 

Now with respect to the issue of CER writers … .

First of all and anecdotal : I remember first reading the MEDDEV Rev 4 document just after it was published in June 2016. Coincidentally, the campaign for that year's US presidential elections was in full swing and it struck me that (at least formally) the requirements for this function were far less than those for writing a CER about, say, many basic and familiar medical devices like syringes or other injection or infusion devices. Indeed, the requirements from MEDDEV Rev 4 for the authors of CERs seemed to be thought up by a forum with a way too academic/bureaucratic mindset and that could never be put to practice in the real world. 

Yet, I do happen to know of at least one individual that has been writing CERs for many, many years (well over a decade). It is someone that I highly respect. He has a double degree (one in medicine and on in electrical engineering) and worked for many years at a leading Notified Body in Germany, before becoming a consultant. Many, many years ago he was already aware of the increasing importance of CERs both for manufacturers and for Notified Bodies (that might lose their designation if they would not have adequate skills to review CERs). He retired just a few years back, but I do not know whether he still occasionally comes to the rescue of manufacturers or Notified Bodies for writing or reviewing CERs. 

Also, I happen to know a local (i.e., based in Lausanne, Switzerland) consulting company that has been writing CERs for a great many years now. Their founders, too, had properly anticipated the increase in requirements for CERs and the business opportunity it represented to them. And it seems very likely that other consulting organizations have done similarly. 

Also, I recently attended a local meeting of Swiss Medtech (an organization representing the Swiss medical device industry) and asked about the feedback the attendees had received from their Notified Bodies regarding the authors of their CERs. It seems currently acceptable (defensible) practice that a knowledgeable person with a product engineering, quality, or regulatory function writes the report, but that it is reviewed (and signed) by someone with the appropriate medical background. It now remains to be seen how the acceptance of this practice evolves over time as CERs keep gaining importance under the EU MDR (mutatis mutandis the EU IVDR). Yet, manufacturers and Notified Bodies alike must keep finding mutually acceptable practices for CERs as to assure an implementation of the requirements that is addressing the device's clinical safety and performance in a practicable goal-oriented manner, not as a bureaucratic exercise. 

With kindest regards,

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

Thank you for always ranting in this forum. Knowing that I am not the only one that loves to rant about the current medical device regulatory landscape (in particular in Europe) is a huge comfort to me ;) ! 

Now with respect to the issue of CER writers … .

First of all and anecdotal : I remember first reading the MEDDEV Rev 4 document just after it was published in June 2016. Coincidentally, the campaign for that year's US presidential elections was in full swing and it struck me that (at least formally) the requirements for this function were far less than those for writing a CER about, say, many basic and familiar medical devices like syringes or other injection or infusion devices. Indeed, the requirements from MEDDEV Rev 4 for the authors of CERs seemed to be thought up by a forum with a way too academic/bureaucratic mindset and that could never be put to practice in the real world. 

Yet, I do happen to know of at least one individual that has been writing CERs for many, many years (well over a decade). It is someone that I highly respect. He has a double degree (one in medicine and on in electrical engineering) and worked for many years at a leading Notified Body in Germany, before becoming a consultant. Many, many years ago he was already aware of the increasing importance of CERs both for manufacturers and for Notified Bodies (that might lose their designation if they would not have adequate skills to review CERs). He retired just a few years back, but I do not know whether he still occasionally comes to the rescue of manufacturers or Notified Bodies for writing or reviewing CERs. 

Also, I happen to know a local (i.e., based in Lausanne, Switzerland) consulting company that has been writing CERs for a great many years now. Their founders, too, had properly anticipated the increase in requirements for CERs and the business opportunity it represented to them. And it seems very likely that other consulting organizations have done similarly. 

Also, I recently attended a local meeting of Swiss Medtech (an organization representing the Swiss medical device industry) and asked about the feedback the attendees had received from their Notified Bodies regarding the authors of their CERs. It seems currently acceptable (defensible) practice that a knowledgeable person with a product engineering, quality, or regulatory function writes the report, but that it is reviewed (and signed) by someone with the appropriate medical background. It now remains to be seen how the acceptance of this practice evolves over time as CERs keep gaining importance under the EU MDR (mutatis mutandis the EU IVDR). Yet, manufacturers and Notified Bodies alike must keep finding mutually acceptable practices for CERs as to assure an implementation of the requirements that is addressing the device's clinical safety and performance in a practicable goal-oriented manner, not as a bureaucratic exercise. 

With kindest regards,

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

Thank you for always ranting in this forum. Knowing that I am not the only one that loves to rant about the current medical device regulatory landscape (in particular in Europe) is a huge comfort to me ;) ! 

Now with respect to the issue of CER writers … .

First of all and anecdotal : I remember first reading the MEDDEV Rev 4 document just after it was published in June 2016. Coincidentally, the campaign for that year's US presidential elections was in full swing and it struck me that (at least formally) the requirements for this function were far less than those for writing a CER about, say, many basic and familiar medical devices like syringes or other injection or infusion devices. Indeed, the requirements from MEDDEV Rev 4 for the authors of CERs seemed to be thought up by a forum with a way too academic/bureaucratic mindset and that could never be put to practice in the real world. 

Yet, I do happen to know of at least one individual that has been writing CERs for many, many years (well over a decade). It is someone that I highly respect. He has a double degree (one in medicine and on in electrical engineering) and worked for many years at a leading Notified Body in Germany, before becoming a consultant. Many, many years ago he was already aware of the increasing importance of CERs both for manufacturers and for Notified Bodies (that might lose their designation if they would not have adequate skills to review CERs). He retired just a few years back, but I do not know whether he still occasionally comes to the rescue of manufacturers or Notified Bodies for writing or reviewing CERs. 

Also, I happen to know a local (i.e., based in Lausanne, Switzerland) consulting company that has been writing CERs for a great many years now. Their founders, too, had properly anticipated the increase in requirements for CERs and the business opportunity it represented to them. And it seems very likely that other consulting organizations have done similarly. 

Also, I recently attended a local meeting of Swiss Medtech (an organization representing the Swiss medical device industry) and asked about the feedback the attendees had received from their Notified Bodies regarding the authors of their CERs. It seems currently acceptable (defensible) practice that a knowledgeable person with a product engineering, quality, or regulatory function writes the report, but that it is reviewed (and signed) by someone with the appropriate medical background. It now remains to be seen how the acceptance of this practice evolves over time as CERs keep gaining importance under the EU MDR (mutatis mutandis the EU IVDR). Yet, manufacturers and Notified Bodies alike must keep finding mutually acceptable practices for CERs as to assure an implementation of the requirements that is addressing the device's clinical safety and performance in a practicable goal-oriented manner, not as a bureaucratic exercise. 

With kindest regards,

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)

• There was virtually no such thing as a CER writer until Rev 4 was issued in June 2016, exactly three years ago.  There were a lot of people who got 6-12 month contracts to write CERs at that time, but after the Rev 4 rush was over, I think the demand slowed to a routine trickle, and since then most of them have gone on to do other things.

• The people who write CERs are either medical writers or RA professionals.  Medical writers write lots of different kinds of documents and RA professionals do a lot of different things.  Neither one writes CERs full time.  (I've only ever written them in the course of getting CE certification, because a CER was needed, and there was no one else to write one.)