The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.

The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.

The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.

The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.

Julie,
The EU-MDR is quite clear in the terminology. The manufacturer writes the Clinical Evaluation Report. The NB writes the Clinical Evaluation Assessment Report.

As part of the pre-market activities the manufacturer implements the clinical evaluation process. One process output is the Clinical Evaluation Report. The manufacturer includes the clinical evaluation process documentation and the Clinical Evaluation Report in the Annex IX application to the NB. For the Clinical Evaluation Plan see Annex IX(2.1, tenth indent). For the Clinical Evaluation Report see Annex IX (2.2(c), fourth indent) and Annex IX(4.4).

The NB assesses the manufacturer's Clinical Evaluation Report and writes a Clinical Evaluation Assessment Report. The NB provides a copy of the Clinical Evaluation Assessment Report to the manufacturer who includes it in the Annex II technical documentation. See Annex VII(4.6)for the NB part and Annex II(6.1(c)).

The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.

Julie,
The EU-MDR is quite clear in the terminology. The manufacturer writes the Clinical Evaluation Report. The NB writes the Clinical Evaluation Assessment Report.

As part of the pre-market activities the manufacturer implements the clinical evaluation process. One process output is the Clinical Evaluation Report. The manufacturer includes the clinical evaluation process documentation and the Clinical Evaluation Report in the Annex IX application to the NB. For the Clinical Evaluation Plan see Annex IX(2.1, tenth indent). For the Clinical Evaluation Report see Annex IX (2.2(c), fourth indent) and Annex IX(4.4).

The NB assesses the manufacturer's Clinical Evaluation Report and writes a Clinical Evaluation Assessment Report. The NB provides a copy of the Clinical Evaluation Assessment Report to the manufacturer who includes it in the Annex II technical documentation. See Annex VII(4.6)for the NB part and Annex II(6.1(c)).

The EU-MDR does not specify the qualifications or organizational requirements for the author of a clinical evaluation report.

There are a few issues that I wish to raise.

I recommend that we stop using the term clinical evaluation report, CER, when referring to the process required by the EU-MDR Article 61. Under the MDD, the result was the CER and it became a shorthand. However, under the EU-MDR there is a more defined process which requires plans, reports, and updates. I think it would be better to refer to the clinical evaluation process rather than one output, the CER.

I'm concerned about using MEDDEV 2.71 revision 4 for the EU-MDR. The MEDDEV is written for the MDD and includes things that are not explicit in the MDD. The EU-MDR has many explicit requirements and they do not align with the MEDDEV. My concern is that following the clinical evaluation process in the MEDDEV will not assure compliance with the EU-MDR clinical evaluation process.

Article 8 suggests there may be harmonized standards for clinical evaluation. I don't believe there is an EN standard for clinical evaluation, let alone a harmonized standard.

Article 9 suggests there may be common specifications for clinical evaluation, but there are none yet.

Until we have clarifying documentation on clinical evaluation, my recommendation is to become familiar with the EU-MDR requirements as new requirements. Develop your company's clinical evaluation process based solely on the EU-MDR. Consider the MEDDEV as background reading and not as the EU-MDR methodology.