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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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 16-Nov-2018 09:11
From: Richard Vincins
Subject: Article 53 CEAR and Discussion
Sorry Article 54 in the Subject Heading. Good day and wanted to clarify some information on Article 54 of the MDR (EU) 2017/745 and some information that I heard recently. I will not re-print Article 54 here in interest of space, but basically the Article says if you have a Class III implantable device or Class IIb active device for medicinal delivery than a clinical evaluation "consultation" is employed. The Notified Body after review of a company's Clinical Evaluation Report for these specific devices generates this Clinical Evaluation Assessment Report (CEAR) that is uploaded to an electronic system (does not exist yet as far as I know). This is then reviewed by an Expert Panel via MDCG who advises Commission and NB on acceptance of product for market, which then the NB can continue the review.
All of that is fairly clear to me ... and I use the word "fairly" quite loosely. What has confused me in a couple public forums in the last few months there has been some comments or indications that a CEAR would be generated for all classes of devices reviewed by a Notified Body. Only the CEAR for Class III implant and Class IIb medicinal delivery would be uploaded to this electronic system, but the others would be maintained as part of the technical documentation review process.
Has anyone heard similar? Your own interpretations of Article 54? Is this one of those Articles that industry really needs to be strong on to make sure it does not get out of control? Do we expect this to be performed retroactively for all those legacy Class III implant and Class IIb medicinal delivery products out there - since none of these existing MDD CE Mark products will have a CEAR (point c and h of Annex IX, Section 5.1 seem to indicate as such)?
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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