I am working towards CE marking of Class IIb device under the new IVDR, and am wondering what the role of the NB is during the clinical investigation/trial stage as part of the CE marking process.
Obviously our competent authority will be notified and cleared to perform the...
I have a Portuguese client (start-up) whose stakeholders are requesting we use Portuguese companies where possible.
1. Do any of you know any ISO 13585 notified bodies based in Portugal for Non-active general medical devices? Also in the future who can perform MDSAP audits.
2. Test House...
Does anyone know when notified bodies will be ready to perform audit to the MDR? Say a company is planning an audit directly to the MDR requirements (and does not hold an MDD certificate so there is no transition), when should this company expect to have their first MDR audit...
I really just want to scream right now so I am hoping someone here can talk me off the ledge.
Ok, during our recent unannounced NB audit we were given a finding because the particular Tech File for the product they were observing during the audit wasn't up to date. What I...
Dear all, last week the European Commission published a document outlining the impact of the Brexit per March 29, 2019.
Depending on your economic operator role and where you are located, you might have to take actions as no CE...
I recently attended a workshop with MDC (one of the notified bodies) and listened to two webinars on the MDR.
Attached are my personal notes on the key changes in the MDR for your learning.
This seems like a dumb question but just to be very sure:
The OEM manufacturer of the devices mentioned in the product scope of the OBL's ISO 13485 & EC cert, must have a valid ISO 13485 & EC cert of their own.
If their certs do not cover those devices, then the NB of the OBL will...
The new MDR speaks a lot of NBs impartiality and independence, inter alia of Manufacturers they assess. Is that even possible where manufacturers hire the services of NBs, which are essentially commercial entities that need to stay financially afloat? Apparently there's a built-in conflict of...
Is there any website other than the Nb's which i can look up for checking:
The authenticity of a NB ?
Whether the NB is authorized for medical device directive ?
Which class of medical device can they audit ?
Certificates issued by them are falsified or not?
Any help would...
Since the MEDDEV guide is not legally binding, I can challenge nonconformity issued by NB, like clinical evaluation does not take into account the MEDDEV 2.7/1 revision 4. Is that right?
Does anyone know what is going on in DQS? In the commission website, DQS also got a "warning symbol", they are our notified body, if they are not competent, we will need to look for another NB quickly. Thanks for your help.
Does anyone know whether Nemko has lost ist accreditation for medical devices? There is a "warning symbol" on the comission website:
"The Commission has not received assurance of the continuing competence of this NB concerning its tasks under 93/42/EEC Medical devices"
What does that mean?
We have submitted our Clinical Evaluation Report to our notified body, and they came back with some cryptic feedback we're not quite sure what to make of it.
We're taking the literature review approach, compliant to MEDDEV. 2.7.1 Rev.3.
The main issue focuses on our Rationale for the...
With our previous NB I sent Technical Files on a disc to their offices for review (too big for email). However, our very new NB is planning to review four technical files by three auditors on our site over two days next year. Now I know TFs were reviewed first hand during an normal audit in the...
My company decided that a certain product (CE marked) will reach to its end-of-life.
In this essence, it would not be manufactured nor distributed anymore.
My question is with regards to the manufacturer's responsibility to notify the NB regarding the above:
1) In case company...
Wondering if anyone can share experiences with respect to the likelihood that critical suppliers/sub-contractors may be audited by Notified Bodies.
I'm looking at an article from LNE-GMED, which raises some concerns...
The article states:
"Per the NBOG’s Best Practice Guide 2010-1; a critical...
We have a full quality system for our class IIa and IIb devices and as such our CE certification indicates compliance with Annex II of MDD 93/42/EEC. A while back; based on very similar products on the market, I realised that one of our IIa products should really be a class I device with a...
Can anyone give me the big picture on notified bodies? Like others, I've been hearing rumors of widespread panic among the NBs, as well as a range of activity (mergers, closings, refusing new clients) for awhile now.
I'm not sure if all if this is in anticipation of specific requirements for...