Regulatory Open Forum

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

• the Technical File should be written to the primary reader - a CA investigator following up on an adverse incident
• some devices have complex but known inherent failure modes

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

The fundamental intent of Technical Documentation (such as Annex II Chapter 4) is to identify which basic general safety and performance requirements apply to a subject device, and then to demonstrate conformity with such general safety and performance requirements.  The Technical Documentation is for showing evidence of fundamentally proper, safe, and effective device design and manufacturing.

The fundamental intent of the Technical Documentation is not to facilitate device failure investigation, nor to showcase or document the failure investigation process.  For example, the GHTF has stated, "The STED would not typically be used to aid the postmarket investigation of adverse events…where different types of information are likely to be called for…"

Though device failure investigation is certainly important, that activity is instead a requirement embodied by fundamentally different aspects of the EU MDR, which have fundamentally different purposes, such as the corresponding aspects of Article 10(9) (e.g., those on vigilance and corrective/preventive action), and such as the failure investigation requirement of Article 89(1).

One sure way to achieve a poor audit outcome is to give assessors different information than what they've requested.  Another fine way to crash is to convolute process A with out-of-scope content from process B.  Accordingly, if a conformity assessment body has requested evidence of GSPR conformity, then I would strongly advise against responding with a showcase of the failure investigation process.  Such an approach is guaranteed to confuse and agitate the assessor, and to increase the number of nonconformities that the assessor documents.

• the Technical File should be written to the primary reader - a CA investigator following up on an adverse incident
• some devices have complex but known inherent failure modes

Dear Colleagues, may I ask how you would manage the GSPR requirements in Chapter 4. of Annex II?

 The chapter requires, that "the documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

 The simplest solution might be to create a table, that has 6 columns, which are the followings:

1. list of the general safety and performance requirements,
2. apply/does not apply to the device,
3. explanation why requirements are considered not applicable,
4. the method(s) used to demonstrate conformity with each applicable general safety and performance requirement,
5. the harmonised standards, CS or other solutions applied,
6. the link to the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.