We had an surveillance audit for CE certication according to Medical Device Directive 93/42/EEC.
One of the non-conformities is as following: "Contracts with critical suppliers do not meet all the requirements of NBOG 2010-1 ANNEX-II.
For example: The content of the contract does not include...
Hello all. This is my first time here, and I am looking for some advice on this standard. The thing is our company manufactures simple medical devices (all in class IIa according to rule X of 93/42/EEC), and the devices are well-proven and widely sold here in Argentina and some other markets...
Does anybody knows can we testing according to EN 285 standard ourselfs? (With calibrated measuring instruments, created tests etc.) Medical device for testing is steam sterilizer.
Or that testing, and issuing test report and certificate must be conducted from external...
I am getting my ISO13485:2016 following the MDR which I will obtain by 1st quarter of 2019. I will then apply for CE Mark which will be under MDD 93/42/EEC as the CE Mark under MDR is not effective yet till May 2020. So the question is will I be able to apply for CE Mark under MDD 93/94/EEC with...
I am really confused. I am preparing a TF SOP and would like some clarification if someone can help shed the light
1. Is the TF now based on the MDR 745/2017. Is the last directive ESSENTIAL REQUIREMENTS ACCORDING TO ANNEX 1 EC DIRECTIVE 93/42/EEC still valid
2. Is there a format for...
May I know, if literature alone can be used for the preparing the Clinical Evaluation Report of a Class-IIb device? How stringent are the NB's requirements on the CER's?
I'd appreciate if somebody could clarify me the right guidance documents that can be used for the clinical...
Would you advise a small business owner to have their product certified after the 93/42 ewg? Is ISO 13485 mandatory or not? Is it even possible to do it without much prior knowledge?
Thank you in advance for the answers:bigwave:
Registry as defined by EU is as follows: An organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes, and comprehensively covers the population defined by exposure to particular device(s) at a reasonably...
We are a small North American manufacturer of Class-2a and 2b devices for Europe. Our devices fall under MDD 93/42/EEC. We have a notified body. Our authorized representative for Europe is based in France.
If there is an adverse event that requires to be reported or an FSCA...
It would be great if you could explain me what is the meaning of this:
Annex II, excluding point Clause 4 conformity assessment route of EC Council Directive 93/42/EEC, as amended by 2007/47/EC concerning medical
Why this needs to be included in the CERs?
I'm revising a risk procedure based on ISO 14971 for my company ( an SME selling mainly class I (some class IIa), pressure relieving devices)).
I want to pull in the requirements of the MDD 93/42/EEC as there are some deviations as per annex ZA of ISO 14971 and I'm stuck...
I was trying to get my head around what edition of the IEC 60601-1 standard is required on European Commission\harmonised standards for medical devices page
There are the following notes:
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying...
I am looking for some guidance interpreting EU Directive 93/42/EEC, specifically (13.3 (b)): "the details strictly necessary to identify the device and the contents of the packaging especially for the users".
Does that necessitate that a full list of contents be placed on the system kit's...
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...
we are new firm/dummies for Device marketing in Europe.We want market surgical gowns,Drapes.
Please share the information reg'..EU
1) How to register&Fee structure.?
2)Any sample submission/template .?
really im thankful to you.
I have a doubt, my company sell our MD together some accesories (all of them are MD, too). Each one of them have its own CE mark. This group is sold by us as a KIT or procedure pack.
Is posible to change the accesories? for example, sell the kit with one accesory called X, and at the same...
Thank you for the time you will take to read this. We are manufacturers of already CE marked Medical Devices.
These Medical Devices are identified in our certificate by its "family" name. Each "family" is composed of, lets say 3 main components, each component can have 20...
If a lab is certified by ASCB (E) UK for ISO 17025 and for a particular ASTM standard would that certification be valid for CE marking by a NB / CB ?
Is traceability to IAF a must for any testing requirements for obtaining CE ? ?
If our QMS is certified to NON IAF accredited...