Regulatory Open Forum

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!

Hi Rebecca,

My main strategy was to read the MDR, and focus on the sections/areas listed in the study guide. As far as study materials, I mainly relied on the MDR text and used a Udemy MDR course to help fill in my general knowledge.  A general suggestion is to pay attention to the details. As I recall, there were a number of questions on reporting timelines and regulatory differences between device types and classes. Hope that helps and best of luck.

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!

Hi Rebecca,

My main strategy was to read the MDR, and focus on the sections/areas listed in the study guide. As far as study materials, I mainly relied on the MDR text and used a Udemy MDR course to help fill in my general knowledge.  A general suggestion is to pay attention to the details. As I recall, there were a number of questions on reporting timelines and regulatory differences between device types and classes. Hope that helps and best of luck.

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!

In addition to reviewing the MDR sections specified in the study guide, I used the attached BSI MDR conformity assessment booklet pages as "flashcards" for studying conformity assessment routes, requirements, and post-approval obligations (e.g., SSCP, PSUR). I paid particular attention to MDR text on additional requirements for devices with medicinal substances, other substances, and human/animal tissues as the latter two were not in my wheelhouse.

Hi Rebecca,

My main strategy was to read the MDR, and focus on the sections/areas listed in the study guide. As far as study materials, I mainly relied on the MDR text and used a Udemy MDR course to help fill in my general knowledge.  A general suggestion is to pay attention to the details. As I recall, there were a number of questions on reporting timelines and regulatory differences between device types and classes. Hope that helps and best of luck.

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!

Thanks so much for your insights! 

Do you have any recommendations on how to prepare for this section of the exam?

In addition to reviewing the MDR sections specified in the study guide, I used the attached BSI MDR conformity assessment booklet pages as "flashcards" for studying conformity assessment routes, requirements, and post-approval obligations (e.g., SSCP, PSUR). I paid particular attention to MDR text on additional requirements for devices with medicinal substances, other substances, and human/animal tissues as the latter two were not in my wheelhouse.

Hi Rebecca,

My main strategy was to read the MDR, and focus on the sections/areas listed in the study guide. As far as study materials, I mainly relied on the MDR text and used a Udemy MDR course to help fill in my general knowledge.  A general suggestion is to pay attention to the details. As I recall, there were a number of questions on reporting timelines and regulatory differences between device types and classes. Hope that helps and best of luck.

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!

Unfortunately, I do not. As others have mentioned in this forum, the RAPS document on the RCC MDR was poorly written (the IVDR document is better). Start with MDR Chapter II to understand manufacturer (and PCCR) responsibilities wrt to conformity of the device. Note that for some product types (e.g., those with substances from blood or plasma) I believe batch verification is mentioned in Annex IX.

Thanks so much for your insights! 

Do you have any recommendations on how to prepare for this section of the exam?

In addition to reviewing the MDR sections specified in the study guide, I used the attached BSI MDR conformity assessment booklet pages as "flashcards" for studying conformity assessment routes, requirements, and post-approval obligations (e.g., SSCP, PSUR). I paid particular attention to MDR text on additional requirements for devices with medicinal substances, other substances, and human/animal tissues as the latter two were not in my wheelhouse.

Hi Rebecca,

My main strategy was to read the MDR, and focus on the sections/areas listed in the study guide. As far as study materials, I mainly relied on the MDR text and used a Udemy MDR course to help fill in my general knowledge.  A general suggestion is to pay attention to the details. As I recall, there were a number of questions on reporting timelines and regulatory differences between device types and classes. Hope that helps and best of luck.

Firstly, congrats to all who passed the first round of RCC exams!
Secondly, for those who passed the RCC MDR exam, now that you've experienced the exam, what study materials/prep would you suggest? How helpful was the checklist provided in the Candidate Guide? 

Thanks in advance!