Regulatory Open Forum

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

1. The organization communicates with its Authorized Representative in accordance with the corresponding procedures in this CE Marking SOP, in the written mandate executed between the organization and Authorized Representative, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
2. The organization communicates with Notified Bodies (if any are involved) in accordance with the corresponding procedures in this CE Marking SOP, in any contracts executed with the Notified Body, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
3. The organization communicates with Competent Authorities by way of the organization's PRRC and Authorized Representative in accordance with the EU Serious Incident Reporting SOP and the Recall SOP.
4. The organization communicates with its importers and distributors in accordance with the corresponding contract(s) and Complaint Handling SOP, and also by way of the Order Fulfillment SOP.
5. The organization communicates with customers and other stakeholders in accordance with the EU MDR Post-Market Surveillance SOP, the Complaint Handling SOP, and the Recall SOP.

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

1. The organization communicates with its Authorized Representative in accordance with the corresponding procedures in this CE Marking SOP, in the written mandate executed between the organization and Authorized Representative, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
2. The organization communicates with Notified Bodies (if any are involved) in accordance with the corresponding procedures in this CE Marking SOP, in any contracts executed with the Notified Body, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
3. The organization communicates with Competent Authorities by way of the organization's PRRC and Authorized Representative in accordance with the EU Serious Incident Reporting SOP and the Recall SOP.
4. The organization communicates with its importers and distributors in accordance with the corresponding contract(s) and Complaint Handling SOP, and also by way of the Order Fulfillment SOP.
5. The organization communicates with customers and other stakeholders in accordance with the EU MDR Post-Market Surveillance SOP, the Complaint Handling SOP, and the Recall SOP.

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

1. The organization communicates with its Authorized Representative in accordance with the corresponding procedures in this CE Marking SOP, in the written mandate executed between the organization and Authorized Representative, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
2. The organization communicates with Notified Bodies (if any are involved) in accordance with the corresponding procedures in this CE Marking SOP, in any contracts executed with the Notified Body, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
3. The organization communicates with Competent Authorities by way of the organization's PRRC and Authorized Representative in accordance with the EU Serious Incident Reporting SOP and the Recall SOP.
4. The organization communicates with its importers and distributors in accordance with the corresponding contract(s) and Complaint Handling SOP, and also by way of the Order Fulfillment SOP.
5. The organization communicates with customers and other stakeholders in accordance with the EU MDR Post-Market Surveillance SOP, the Complaint Handling SOP, and the Recall SOP.

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

1. The organization communicates with its Authorized Representative in accordance with the corresponding procedures in this CE Marking SOP, in the written mandate executed between the organization and Authorized Representative, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
2. The organization communicates with Notified Bodies (if any are involved) in accordance with the corresponding procedures in this CE Marking SOP, in any contracts executed with the Notified Body, in the design change procedures, in the EU Serious Incident Reporting SOP, and in the Recall SOP.
3. The organization communicates with Competent Authorities by way of the organization's PRRC and Authorized Representative in accordance with the EU Serious Incident Reporting SOP and the Recall SOP.
4. The organization communicates with its importers and distributors in accordance with the corresponding contract(s) and Complaint Handling SOP, and also by way of the Order Fulfillment SOP.
5. The organization communicates with customers and other stakeholders in accordance with the EU MDR Post-Market Surveillance SOP, the Complaint Handling SOP, and the Recall SOP.

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

Start with ISO 13485:2016, 7.2.3 second paragraph. Expand you implementing SOP to cover the regulators in the MDR which should include your Authorized Representative, Notified Body, and Competent Authority.

I add Authorized Representative because some have my clients have an Authorized Representative that reviews the Technical Documentation, etc. as if they were a Notified Body.

To satisfy the Annex III requirement point to the SOP.

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks

As part of the new technical documentation requirements for medical devices, manufacturers are required to create a procedure for "methods of communication with competent authorities, notified bodies, economic operators, and users."

I can't seem to find many good resources on this to make sure all bases are covered, has anybody else, and if so please do share them!

Many Thanks