Regulatory Open Forum

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

This doesn't look right to me.

My model is a Quality Management System, QMS, that includes other systems, such as the PMS system, the PMCF system, etc.

In general, each system requires a plan, the plan's execution, an initial report, and report updates. In the EU-MDR there are plans inside plans, but I'm going to pull them for this description.

For PMS you will have an SOP at the QMS level that implements the requirements in Article 83. It will also have a template for writing a PMS Plan that implements Article 84 and Annex III(1.1)

You will also have template for writing a PMSR or PSUR that implements Article 85, Article 86, and Annex III(1.2).

Then for each device (or family of devices) you will write a specific PMS Plan using the template, execute the plan, and write the initial report using that template.

The pattern carries forward. Write a separate SOP with templates for each system, and then use the templates to write the plans and reports.

The systems involved here are:
Clinical Evaluation System with a Clinical Evaluation Plan and a Clinical Evaluation Report

A Clinical Development System with a Clinical Development Plan (as part of the Clinical Evaluation Plan) and a Clinical Development Report

A PMCF System with a PMCF Plan (as part of the PMS Plan)  and a PMCF Evaluation Report

A Trend Analysis System with a Trend Analysis Plan (as part of the PMS Plan) and a Trend Analysis Report


You mention "PMCF template (checklist)". I infer that by PMCF template you mean PMCF Plan template. Looking at the requirements for the PMCF Plan Annex XIV(6.1) I don't think a checklist would be satisfactory.

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".

The MDD approach won't work for the MDR. You need to start again with a different approach.

The EU-MDR has a variety of systems which are also part of the Quality Management System, QMS. Article 10(10) requires the manufacturer to create a PMS system, PMSS, in accordance with Article 83. Article 10(9)(i) requires that the PMSS be part of the QMS.

You should write an SOP in the QMS that implements the requirements of Article 83. It could have templates for the PMS Plan, the PMS report (PMSR), and the PSUR.

For each device, or family of devices, you will then write a PMS Plan using the template from the SOP. Note that the PMS Plan requires a PMCF Plan and a Trend Reporting Plan. (In my course I show the concept of plans inside plans as Russian matryoshka dolls.) Then, you will implement the PMS Plan and use the results to write your initial PMSR or PSUR, depending on the device class determined from Annex VIII.

You will apply to an NB, probably following Annex IX. Part of the application includes (Annex IX(2.1), eight indent) "the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan".