Regulatory Open Forum

1. How do I have to handle the deputies?
   1. Do they have to be officially appointed (EUDAMED and/or internal letter of appointment) as well, or is being deputy a kind of delegation of duties?
   2. How needs a deputy to sign ("by order of prrc" or "on behalf of prrc" or  without any kind of disclaimer)?
2. Do I need some kind of declaration of consent of the persons in question before I submit their names to EUDAMED (--> data privacy)? Should this be part of the letter of appointment?
3. How do I handle questions regarding liabity? Does the "directors and officers liability Insurance" need to include the names of the prrc's or the position of prrc as appointed?
4. When we have several PRRC, may they sign as PRRC or do they need to be exact (e.g. PRRC Vigilance)?
5. and, last question: has anyone a template, which she/he might like to share?

Don't have deputies. A person is either a PRRC or not. You can have more than one PRRC. If you do then "their respective areas of responsibility shall be stipulated in writing". I recommend that you give each person every area of responsibility. That gives you flexibility.

The appointment letter should come from top management as defined in ISO 13485:2016 which incorporates the definition in ISO 9000:2015.

It should say, "I appoint the following people as a Person Responsible for Regulatory Compliance under the EU-MDR Article 15. Each person has responsibility related to Art. 15(3)." <List of Names>

Under the assumption your QMS implements 21 CFR Part 820, put the appointment letter in the Quality System Record, 820.186. ISO 13485:2016 doesn't have a similar place.

The PRRC doesn't have to sign anything. The role is to assure that certain things happen, not to do them. If your company has an approach to "official" acts performed by the Management Representative, then use that as model.

I don't think there is a privacy issue in Eudamed because you are not providing personal information. This is company information.

1. How do I have to handle the deputies?
   1. Do they have to be officially appointed (EUDAMED and/or internal letter of appointment) as well, or is being deputy a kind of delegation of duties?
   2. How needs a deputy to sign ("by order of prrc" or "on behalf of prrc" or  without any kind of disclaimer)?
2. Do I need some kind of declaration of consent of the persons in question before I submit their names to EUDAMED (--> data privacy)? Should this be part of the letter of appointment?
3. How do I handle questions regarding liabity? Does the "directors and officers liability Insurance" need to include the names of the prrc's or the position of prrc as appointed?
4. When we have several PRRC, may they sign as PRRC or do they need to be exact (e.g. PRRC Vigilance)?
5. and, last question: has anyone a template, which she/he might like to share?

Don't have deputies. A person is either a PRRC or not. You can have more than one PRRC. If you do then "their respective areas of responsibility shall be stipulated in writing". I recommend that you give each person every area of responsibility. That gives you flexibility.

The appointment letter should come from top management as defined in ISO 13485:2016 which incorporates the definition in ISO 9000:2015.

It should say, "I appoint the following people as a Person Responsible for Regulatory Compliance under the EU-MDR Article 15. Each person has responsibility related to Art. 15(3)." <List of Names>

Under the assumption your QMS implements 21 CFR Part 820, put the appointment letter in the Quality System Record, 820.186. ISO 13485:2016 doesn't have a similar place.

The PRRC doesn't have to sign anything. The role is to assure that certain things happen, not to do them. If your company has an approach to "official" acts performed by the Management Representative, then use that as model.

I don't think there is a privacy issue in Eudamed because you are not providing personal information. This is company information.

1. How do I have to handle the deputies?
   1. Do they have to be officially appointed (EUDAMED and/or internal letter of appointment) as well, or is being deputy a kind of delegation of duties?
   2. How needs a deputy to sign ("by order of prrc" or "on behalf of prrc" or  without any kind of disclaimer)?
2. Do I need some kind of declaration of consent of the persons in question before I submit their names to EUDAMED (--> data privacy)? Should this be part of the letter of appointment?
3. How do I handle questions regarding liabity? Does the "directors and officers liability Insurance" need to include the names of the prrc's or the position of prrc as appointed?
4. When we have several PRRC, may they sign as PRRC or do they need to be exact (e.g. PRRC Vigilance)?
5. and, last question: has anyone a template, which she/he might like to share?

Don't have deputies. A person is either a PRRC or not. You can have more than one PRRC. If you do then "their respective areas of responsibility shall be stipulated in writing". I recommend that you give each person every area of responsibility. That gives you flexibility.

The appointment letter should come from top management as defined in ISO 13485:2016 which incorporates the definition in ISO 9000:2015.

It should say, "I appoint the following people as a Person Responsible for Regulatory Compliance under the EU-MDR Article 15. Each person has responsibility related to Art. 15(3)." <List of Names>

Under the assumption your QMS implements 21 CFR Part 820, put the appointment letter in the Quality System Record, 820.186. ISO 13485:2016 doesn't have a similar place.

The PRRC doesn't have to sign anything. The role is to assure that certain things happen, not to do them. If your company has an approach to "official" acts performed by the Management Representative, then use that as model.

I don't think there is a privacy issue in Eudamed because you are not providing personal information. This is company information.

1. How do I have to handle the deputies?
   1. Do they have to be officially appointed (EUDAMED and/or internal letter of appointment) as well, or is being deputy a kind of delegation of duties?
   2. How needs a deputy to sign ("by order of prrc" or "on behalf of prrc" or  without any kind of disclaimer)?
2. Do I need some kind of declaration of consent of the persons in question before I submit their names to EUDAMED (--> data privacy)? Should this be part of the letter of appointment?
3. How do I handle questions regarding liabity? Does the "directors and officers liability Insurance" need to include the names of the prrc's or the position of prrc as appointed?
4. When we have several PRRC, may they sign as PRRC or do they need to be exact (e.g. PRRC Vigilance)?
5. and, last question: has anyone a template, which she/he might like to share?

1. How do I have to handle the deputies?
   1. Do they have to be officially appointed (EUDAMED and/or internal letter of appointment) as well, or is being deputy a kind of delegation of duties?
   2. How needs a deputy to sign ("by order of prrc" or "on behalf of prrc" or  without any kind of disclaimer)?
2. Do I need some kind of declaration of consent of the persons in question before I submit their names to EUDAMED (--> data privacy)? Should this be part of the letter of appointment?
3. How do I handle questions regarding liabity? Does the "directors and officers liability Insurance" need to include the names of the prrc's or the position of prrc as appointed?
4. When we have several PRRC, may they sign as PRRC or do they need to be exact (e.g. PRRC Vigilance)?
5. and, last question: has anyone a template, which she/he might like to share?