Kim,
Congratulations on your new assignment. Bringing a product to Europe is exciting. Two big steps required. 1) Get a CE Mark for your quality system from a Notified Body according to the requirements of ISO 13485 and 2) Submit the technical / clinical dossier for each product to the Notified Body for CE mark on the product(s).
As the Notified Body is the gate keeper for both certifications, selecting this important business / regulatory partner is a critical multi-functional decision.
To accomplish the first objective, you will need to partner with the quality assurance manager and evaluate the 13485 readiness of the quality system and organization.
To accomplish the second, a thoughtful assessment of the status of the product is required. Some of the key questions are how long has it been used in the US, how much clinical information is there already (was the device used in a US clinical trials, for example), is the device / procedure unique or well accepted therapy? All of these factors go into the determination by the notified body as to whether the device can be CE marked without a device-specific clinical trial.
All devices need a structured (clinical) literature review, which is often done by a contracted medical writer. Some devices get a CE mark based on a literature review only. Other devices require a clinical trial. A US clinical trial if done under FDA controls will likely be acceptable. A product approved under 510(k) without a clinical trial may or may not require a clinical trial to gain the CE mark.
Your partners in this preliminary evaluation are the R&D manager and the clinical affairs manager. Your role as the regulatory voice on the team is to find the Medical Device Directive and to understand the structure of the requirements, the sequence of the steps, and the role of the Notified Body. Once the team has a plan, there may be a big project to take the FDA submission documents and to map this information into the requirements of the technical dossier. This part of the project often is undertaken by the regulatory team member.
- Kate
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Katharine Stohlman RAC
Waltham MA
United States
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Original Message:
Sent: 01-24-2013 09:01
From: Kim Finch
Subject: Notified Body Minor Observation - Clinical Evaluation Report
I work for an OEM of orthopedic implants, I recently joined the firm and we currently on;y market in the US. THe owners have recently request we move forward in applying for a CE mark and marketing in EU. Could someone point me in the wright direct to even begin the clinical evaluation of our product line? Is the regulatory person usually the one who prepares these evaluations?
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Kim Finch
Regulatory Affairs Manager
CHOICE SPINE
Knoxville TN
United States
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Original Message:
Sent: 01-23-2013 01:47
From: Florian Tolkmitt
Subject: Notified Body Minor Observation - Clinical Evaluation Report
Trina,
if I understand right, that the observation is, that there is no evidence of who the author is, this can simply be solved by providing the CER with the author(s) signature(s) and adding evidence of the author(s) qualification(s) to write the clinical evaluation. The way you mention seems to be OK. What we do, is to attach a CV of the authors, that shows the prefessional background in the area of evaluation.
From my point of view, this documentation should be standard in clinical evaluations and it sounds a little strange that they have not asked for it before.
However, I think that what your notified body might be pointing at, is that it is not clear to them why you chose the specific authors. This is something that came along with MEDDEV 2.7.1. Rev.3 and there are acutally notified bodies that ask for an argumentation or reason why an author is chosen. The reason is: because he/she is qualified to be an author and that is because he/she is an expert in the area of product application.
Just writing this down and providing the above mentioned evidence of qualification should solve your issue.
Asking for this argumentation is in line with documenting the whole process of clinical evaluation including where you look for data and why certain data sets are e.g. not included in the evaluation.
Hope this helps
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de
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Original Message:
Sent: 01-22-2013 13:58
From: Trina Slabiak
Subject: Notified Body Minor Observation - Clinical Evaluation Report
After completing all of the Clinical Evaluation support documents for Class I and Class II Surgical Devices, we had a minor observation in an audit that there was no objective evidence that the author (a clinical professional) had created the Clinical Evaluations.
What is the best way to solve this issue with the Notified Body? Is it possible to simply list my clinical qualifications along with the product categories included within these reports? I am not a physician but I have a few allied health certifications. All of the surgeon preference evaluation (SPE) reports were completed by board certified surgeons.
Thanks for your input,
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Trina Slabiak RAC
San Francisco CA
United States
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