Under the MDR, whenever a Notified Body (NB) is involved in the conformity assessment procedure, the NB is required to develop a clinical evaluation assessment report (CEAR). See Annex VII, Requirements to be met by Notified Bodies, Subsection 4.6, Reporting. In addition, the need to document an assessment of clinical evaluation in a CEAR is found in other parts of the MDR.
Also, the EU guidance on clinical evaluation (MEDDEV 2.7/1 Rev 4) states that NBs should document the assessment of clinical evaluation in a CEAR. The previous revision of the guidance also indicates that a CEAR should be developed; whereas, the 2003 version states that the assessment should be in documented in a report.
Under the directives, regarding legacy devices, NBs are expected to have documented their assessments either in a general report on the Technical Documentation or in a separate CEAR. Under the MDR, whenever NBs assess or reassess a clinical evaluation report (CER), including for legacy devices, NBs will need to document their assessments in CEARs.
There is a lot going on here, so I'll make a short summary.
The manufacturer implements a clinical evaluation system as part of the QMS. For each device there is a clinical evaluation plan, a clinical evaluation report, and means to update the clinical evaluation information. All of this is in the Annex II technical documentation. This applies to all device types. (For me, a device type is the class plus attributes. For example, a Class I device with a measuring function is a device type.)
Under Annex IX, the NB audits the QMS and reviews the technical documentation, which includes the Annex II clinical evaluation information.
The NB activities include preparing a clinical evaluation assessment report and submitting it to an Article 106 expert panel. The question is what are the conditions under which the NB performs each of the activities.
According to Annex VII, 4.5 the NB implements procedures for conformity assessment. (This is a detailed section that all manufacturers need to understand.) Annex VII, 4.5.5 describes how the NB assesses clinical evaluation. Annex VII, 4.6 on reporting, first paragraph, 3rd indent requires the NB to clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation assessment report.
In short, whenever the NB assess Annex II technical document it assesses the clinical evaluation information and prepares a clinical evaluation assessment report.
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product, the NB transmits the clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation to the Commission. [Annex IX, 5.1.a, second paragraph]
The Commission transmits it to the Article 106 Expert Panel. [Annex IX, 5.1.a, third paragraph]
The Article 106 Expert Panel decides whether or not to issue a scientific opinion.
This should answer the questions of the NB's preparing a clinical evaluation assessment report and when it goes to Article 106 Expert Panel.
You ask, "Do we expect this to be performed retroactively for all those legacy Class III implant and Class IIb medicinal delivery products out there …?"
The best answer is that there are no legacy products and no concept of retroactivity. To put a CE Mark on a device under the EU-MDR, the manufacturer must start with a "clean piece of paper". There may be (a lot) of work done under the MDD that could be brought over, but it is a fresh start. Every such device will have clinical evaluation information following the EU-MDR, an NB clinical evaluation assessment report, and an Article 106 Expert Panel decision on offering a scientific opinion.
As said on TV, "BUT WAIT – THERE IS MORE!!!!"
For Class III devices and Class IIb active devices intended to administer and/or remove a medicinal product, the manufacturer may decide to have a consultation with an Article 106 Expert Panel. [Article 61, section 2]
The NB's Competent Authority reviews the NB's assessments of the manufacturers' technical documentation, in particular the clinical evaluation documentation, on a sampling basis. [Article 44, section 8 and Article 45, section 1]
The Commission prepares an annual review of the devices subject to Annex IX, Section 5.1 and submits it to the European Parliament, to the Council, and to the MDCG. [Article 54, section 4]
In short, clinical evaluation is a big deal in the EU-MDR and subject to many levels of scrutiny.
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