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ISO 13485 & EU MDR - Expert Advice Community

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  • MDR vs CFR 21

     “Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”  

    Gap analysis MDR vs CFR 21 

  • Direct part marking for reusable devices class I

    I have a question regarding direct part marking for reusable devices class I
    Is it a label or can it be a serigraphy?

  • Question on Monitoring and measurement of product

    I have a question about section 8.2.6 of ISO 13485, concerning the following: “As appropriate, records shall identify the test equipment used to perform measurement activities.” Exactly how far do we have to satisfy this requirement? Right now all our measuring equipment is listed in our ERP database along with calibration information. But do we have to identify the exact tool used each time a measurement is made on a part? I’m asking as our ERP system doesn’t go into that level of detail: I can list what type of tool to use, but not actually the tool ID used specifically for each measurement.

  • What rules should be applied to 3D printed - patient specific products?

    What rules should be applied to 3D printed - patient specific products (we understand that 3D product is not under custom made according to MDR, should be CE marked - but labeling should contain patient data as custom made product). This is not serial or custom, is in the middle - patient specific - missing term and conditions in MDR. We have to put CE on our products and DoC (we declare conformity of the process) - but finally the clinician should provide declaration based on individual paient´s data?

  • Dental burs

    Hi, dental burs ( for endodontic treatment non vital teeth, no surgery treatment, odonto treatment) are critical or semicritical devices , in the light of MDR. Dental burs( novital teeth, nosurgery, odontotreatment) must be "sterile" at time of use or it is ok to be only " sterilizated" and keep in a apropriate dental burs holder? Every dental bur ( for nonvital, nosurgery, odontoterapy)must be pack individual with an integrator type 5? Or in a dental burs holder after autoclaving? Thank you very much!

  • Qualifications of EU-rep from May 26th

    Well it is implemented. The question with the toolkit I will discuss with our client. My main question is about the qualifications of the EU-rep from May 26th. As we interpretate the law you need an EU-rep following article 15 qualifications as the IVDD law is obsolete. This regardless of the extension period for IVDD devices on the market. Our UK counterpart says no, you don’t need a new EU-rep following IVDR qualifications for IVDD equipment which is still valid with IVDD certification. So we have a different point of view. We had some information from the UE which states lawfully you need a EU-rep following new IVDR/MDR regulations regardless the extension period for IVDD. For IVDD you follow the IVDD guidelines but as the regulation is obsolete from a legislative point of view you would need an EU-rep based on IVDR/MDR regulations (as IVDD/MDD regulations are not in force anymore but act as reference only). It would only make sense if the IVDD stays in force for IVDD equipment until the last IVDD is from the market. am curious on your opinion.

  • Do we need ISO 13485 if we have IEC 62304?

    Do we really need ISO 13485 or is it just icing on the cake? We have to have IEC 62304.

  • Management review questions

    I would like to ask two questions regarding the management review. 1. risk policy that is referred to in the template - what is this exactly? is it the risk management policy according to ISO14971 or is it a general risk assessment for the policy? how exactly can it be evaluated during management review? 2. the matrix of KPIs - is it ok if timewise it is approved during the first MB meeting, or does it need to be prior (in our case, 3 months prior when the SOP was established) and presented to the management for review?

  • Most efficient steps in regulatory pathway to introduce class III implantable device

    in order to introduce a class III implantable device manufactured in our own startup company, what is the most efficient steps in the regulatory pathway you would you advise? Eg Establish QMS - compile dossier of pre-clinical evidience - seek regulator approval for phase I safety trial - CE mark product - ISO13485 certification?
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