Klaus I believe that many NBs will continue to assess technical documentation on site. Especially with the sampling procedure. When they have only 5% of the products to assess on the first cycle and they know what to expect after the initial assessment, they think it will be easier for them. And remember, that sampling is not for class III products.
As regards to the issue you mentioned about the 3rd non-compliant technical documentation: Many NBs have a different system of assessing the surveillance assessments. While they have deficiencies in the initial assessment, in the other cycles they have categorized non-conformities. Thus they can categorize a non-convenient case as Minor and assess the corrective action in the next surveillance audit. Then I suppose that if it is not fixed, they can suspend the certificate.
Please keep in mind that most of the NBs are on the way of changing their technical documentation assessment and auditing procedures
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 30-Sep-2020 03:04
From: Klaus-Dieter Ziel
Subject: EU MDD & EU MDR - Audit process
Hi,
establish a sampling plan, sample technical documentation(s), assess technical documentation(s) and assess the quality system documentation are all tasks BEFORE a notified body goes on-site for a quality managment system audit. There is not too much wihich goes parallel and this process in the MDR is very differnet compared (and lengthy) compared to the well known MDD process.
I believe that many manufactuerers will be very surprised about this different MDR process, because it could significant increase the time needed from the application until the issue of the MDR certificate!
In addition, what will happen, if for example 2 of the 3 technical documentations sampled found in compliance with the MDR, but the third one not? What happens with the planning of an on-site audit? Will it still be possible to cover the product(s) from the third technical documentation in the on-site auditing, or must these product(s) excluded?
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Klaus-Dieter Ziel
Hamburg
Germany
Original Message:
Sent: 29-Sep-2020 04:41
From: Richard Vincins
Subject: EU MDD & EU MDR - Audit process
Hello Anon,
For an initial EU MDD or EU MDR audit they would perform the Stage 1 and Stage 2 QMS audit. The Technical Documentation is usually done sometime before Stage 2, though this really depends on the Notified Body. As mentioned sometimes the Stage 2 QMS audit and Technical Documentation review are both done onsite. Also it really depends on your contract and what you have agreed with the Notified Body for the audit process and when activities would be performed. In the current situation of the world the conduct of a Stage 1 and Stage 2 audit is moving around alot, where Stage 1 is done remotely, but Stage 2 should still be done onsite. Regardless of when the Stage 2 QMS audit and Technical Documentation review/audits are performed you get 2 certificates. The QMS certificate including EU MDR does not mean you can start marketing the product - you must wait until you have the CE Certificate (review of the technical documentation) before you can start placing product on the market. So many view the Technical Documentation review as the hurdle point.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 29-Sep-2020 02:46
From: Margit Widmann
Subject: EU MDD & EU MDR - Audit process
Actually, it is not a real sequential procedere, more two tasks in parallel, as there are also different teams involved of a NB. This depends also on the workload. What is crucial, only the Certificate allow CE-labeling and to bring the products into the market.
Am 29.09.2020 08:21, schrieb Spyros Drivelos via Regulatory Affairs Professionals Society:
Hi Anon, As Margit said, Stage 1 is more of a preparatory stage. For the stage 2 I have some different info. Some NBs assess first the technical... -posted to the "Regulatory Open Forum" community
Original Message:
Sent: 9/29/2020 2:20:00 AM
From: Spyros Drivelos
Subject: RE: EU MDD & EU MDR - Audit process
Hi Anon,
As Margit said, Stage 1 is more of a preparatory stage.
For the stage 2 I have some different info. Some NBs assess first the technical documentation and then perform the audit. Some others do both of them on-site on the same time.
Some NBs do not give a lot of effort or attention to Class IIa devices.
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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