is it mandatory to have them on the accessory when it falls under UDI of system ? As long as the device complies with the (minimum) labelling requirements in Section 13 of Annex I of the MDD. But if you want to be more specific, we can say that there are 3 sub … But distributors are not required to review the technical documentation. i.e. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. Unfortunately, if you fail to transition to the new MDR before the May 2020 deadline, your business will be unable to import, export or sell products. Meaning, ownership of the devices is transferred from the manufacturer or importer to a distributor within Europe. There is no EU specific guidance on the topic of labelling. In short; as an intermediary in a third country you have no obligations under the EU MDR. According to them, we better appoint one importer and make this one importer do the duties under MDR, especially EUDAMED data entry. The EUMDR doesn’t address maintenance activities either, as such, but it does place obligations on the suppliers of replacement parts and components intended for that purpose. Class II or III) from those that are not (i.e. MDCG 2019-11 Guidance has the following example, but it is unclear why is this not classified as Class IIa under MDR Rule 11 b? Thank you for your question about the EU declaration of conformity. The EU MDR does not regulate such specifics. Hello, We have Class I medical device according to MDR. There is no confusion that syringe is a medical device. September 2017 update of EU MDR regulations includes Base-UDI procedure. Also, in Article 13(2)(c), they shall verify that the device is labelled and accompanied by the required instruction for use. For example, if we are providing translation of the labelling to the national language, we would fall under this requirement (provided that we don’t make any changes to the original). Please read Article 23 in case it is applicable. They were not mentioned in the MDD, but they have been in place for several years already. Then and only then, they can draw up a declaration of conformity before applying for CE marking. Where can I find information about Base-UDI (for product families)? But if the MDD certificate was valid when the device entered the EU distribution chain, the device can continue to be distributed or used even if the MDD certificate subsequently expires. Nevertheless, this is confirmed when one looks at the requirements for the notified body in Annex VII. In practice empty barrels of syringes and rubber stoppers are manufactured by different manufacturers. Condition #1 The NB certificate for the device must still be valid (i.e. Higher levels of packaging shall not be understood to include shipping containers.” “MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. More information is available on the respective entities’ websites. I know some countries accept English in stead of their official languages, especially for a professional use. Question: Have the language requirements for labels and instructions changed compared to the current MDD? And the bar for “equivalence” is so high as to be impracticable unless you yourself are the owner of the “predicate”. We understand that a manufacture have to accompany information, which includes an IFU, in official language according to Article 10(11) . It also says that agreement must include “(b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer…” It is a matter to be discussed with your notified body. Device label with existing (old) NB address VS Device label with new NB address: 4. –> I have no idea Medical device manufacturers have to write IFU in 24 EU offical languages Progress report from the European Commission. On a continuous basis, companies falling under the scope of EU MDR are tasked with entering and maintaining data in EUDAMED, including but far from limited to keeping the UDI (Unique Device Identifier) up to date. But yes, this is the same name and address of the manufacturer as was previously required by Annex I of the Directives. The requirements for the provision of service, including installation, are given in ISO 13485. However, it is not the case for devices which do not need the involvement of a notified body under the EU MDR. Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices. The following approach may help to eliminate those software functions that are not a medical device, and to differentiate between those that are intended to be used in clinical decision making (i.e. Please refer to the European Commission guidance on this topic. However, this requirement is not mentioned under Annex I chapter III (GSPR). Regarding “The additional five years conditional transition period #1” & “Article 16”. I see that you updated the reply with the bold part (post installation servicing). As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial? Nothing prevents a manufacturer from incorporating requirements from the EUMDR into quality system documents at any time. Thank you for your question about technical documentation. Mine product will be classifeid as Class IIa and based outside the EU, do I need an EU authorised representitives as well? Our manufacturing site and our head office will change this summer. The manufacturer must also comply with the new EU MDR requirements for post-market surveillance, vigilance and registration. So, while the EU MDR doesn’t address such specific topics as the languages needed for user interfaces, it does obligate manufacturers to consider these types of questions in the course of their risk management activities. If so, what is the basis for validity if the NB no longer exists? Answer: Yes. Thank you in advance, when offered for sale or supply), not with the products being imported. Thankyou in advance. You can make available on the market a device under your name, registered trade name or registered trade mark, without assuming the obligations incumbent on manufacturers. Thank you in advance. While MDCG 2019-11 is primarily concerned with medical device software in Classes III, IIb and IIa, it does contain one example of a Class I medical device software. Whether any item fulfils the definition of a medical device depends on the claims made by its manufacturer. Thank you for your question about UDI and EUDAMED. Concerning NB-MED 2_12-1 on PMS, Rev. In the case a Medical Device manufacturer sell a MD before 2020, but his certificate MDD is expired, con I continue to put on the market the Md (if the Md was produced when the certificate was still valid)? 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