eu mdr requirements

eu mdr requirements

Thank you for your question about UDI assignments. We have not been able to find guidance of this specific issue anywhere. Thank you for your question about the importers’ obligations. The device is available in a number of types/configurations, depending on the patient, one type is used. These are Notified Body approved products. Question: Is guidance on the new regulation available from any official sources? See the ‘Blue Guide’ on the implementation of EU products rules 2016”. The Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. Could you please clarify par. This additional transition period is limited: Placing on the market date for MDD certified devices ends in May 2024, putting MDD certified devices into service ends in May 2025. As a result, regardless of their classification under the EU MDR, MDD Class I devices must either be fully compliant with the EU MDR by May 26th 2020 or be withdrawn from the EU market. Annex I of the regulation contains cybersecurity related requirements both for pre-marked and post-market aspects. What do you need to provide, because it contains also propriatery information that you don’t want to share. The date of application is only relevant to manufacturers who are currently still placing devices on the EU market according to the MDD, because that possibility will be very limited after the date of application of the EU MDR. Can you hold a CE MDD and a CE MDR certificate for the same device from two different Notified Bodies? This is where you can find answers to the most frequently asked questions. Language requirements are decided by the Member States. New guidelines to define cybersecurity requirements appeared, first by FDA and then by EU following the publication of EU MDR 2017/745. device label(s), packaging label(s), etc. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and … Thank you for your question about repacking damaged goods. This option is not available to (MDD) Class I devices, the so called “self-declared” devices. We are a sterile Services department sterilising instrument trays between uses. For organizations certified to ISO 13485:2016, supplier performance is monitored and management review includes a review of the data and evaluation of supplier performance. Our device belongs to class III implantable devices, however has ability of resorption 90 days after implantation. Device name which is not trademarked or registered needs to be translated or not in the label. Thank you for your question about distributors. The activity you describe above is different from the specific activities described in paragraph 2 (a) and (b). The intended use and classification are not dependent on the activities of the user. Or once you are issued with an MDR certificate, does the MDD certificate become invalid? In that case, will it be Class I ? Thank you for your question about clinical evaluation. If we use the component which has the MDR notified body number engraved as replacement, would we then need to supply the user with a new MDR compliant IFU additionally? However, a device can only conform to either the MDD or the EUMDR. already in the distribution chain, will be unaffected. As a result, MDR may be qualified as one of the most complex sets of requirements for medical devices to date. The only reprocessing requirements contained in the EU MDR are those for reprocessing single use devices. If the “Union” is defined as both 28 EU members and the members of the European Free Trade Association (EFTA) which Swiss is included, then they do not need representative. As long as the different variants share the same intended purpose, same intended target groups, same intended clinical benefits and clinical outcomes etc., it may be legitimate to consider them as one and the same device. It is determined by the location of the manufacturer. Question: Is it true that medical devices which conform to the current MDD can still be placed on the EU market after May 2020? As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. 120 (3)). Thank you for your question about the human readability of information. EU MDR Timelines . Is it compulsory? Yes. Can a company import a product X from a non-EU manufacturer and act at the same time as the distributor of the same product? You are recommended to consult a suitably qualified lawyer who is familiar with your business model. So my question is we only have MDD certified products, if we haven’t implemented our procedure changes within our QMS such as pms procedure vigilance procedure can they give us nonconformities to the MDR in audits such as MDSAP audits or ISO and Tech file audits. All manufacturers that wish to sell their product in the EU need to ensure that they satisfy the EU MDR requirements, or they may see their products removed from sale. i.e. They are typically differences. Compared to the MDD 93/42/EEC, there is a need for much more information on the labels under the EU MDR, because device safety and clinical effectiveness data is required to be shared transparently with users (both medical staff and patients/end users). That means, a clinical investigation to be conducted in all twenty-seven EU member states would require authorisations in all twenty-seven EU member states. Thank you for your question about re-processing of single use devices. If EUDAMED is not ready by May 2020, economic operators will be allowed 24 months from the date when EUDAMED is ready. MDD compliant), where the component to be changed has the CE mark with notified body number engraved on it, would we then need replace the component with one that has the MDD notified body number engraved? Requirements for manufacturers to provide clinical data obtained via post-market clinical follow-up (PMCF) are set to both increase and intensify under the European Medical Devices Regulation (MDR), necessitating additional planning by companies planning to certify or gain re-certification under the new Regulation. Will it be possible to manufacture a “safety stock” of them and have at our warehouse in EU and be able to sell them after May 26th 2020? Consider the next few years as a transition period. Regarding Article 120. They have different roles and obligations under the regulations but this is with regard to the individual device. In fact, of the 27,000 MedTech companies in Europe, 95% are of small to medium size and most have less than 50 employees. Whereas, if there is no withdrawal agreement, the so called “no deal”, your company cannot continue to place its devices on the EU market after the Brexit date on the basis of their UK notified body certificate. Is it acceptable to use a QR code to identify the importer information on the product? If your company intends to continue marketing its Class I device as an MDD compliant device and add additional information or symbols, that is also possible. ; MDD Class I devices which under the EU MDR do not need a notified body) is Article 120(4). (b), (c) and (d). Regarding Article 16 of the obligations of manufacturer for the company that is not mentioned as the manufacturer on the label but put their device name on the product – is it considered as a manufacturer as well and needs to be in possesion of TD? If we apply this method, can we still act as our own importer and register ourselves as the manufacturer and also the importer in the EUDAMED database? You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51). Nevertheless, this is confirmed when one looks at the requirements for the notified body in Annex VII. In case of repair of one product sold before the transitioning (i.e. Devices must be suitable for their intended purpose during normal conditions of use, Annex I(1). If a Notified Body (NB) has officially withdrawn from European MDR designation and no longer holds valid EU MDD designation, will the EC Certificates and ISO 13485:2016 certificates issued by the NB still be considered valid, if they have no expired? EU MDR directive and its requirements, please reach out to us by filling in this form. By Darragh McMorrow, May 30, 2019. However, your question really falls within the scope of the general requirements of Chapter I of Annex I. As far as I could check so far, the requirements given in ISO 13485 are important to keep the medical device well installed and maintained. Hello, My questions are; A similar question is, can importers also be distributors? What is the last date of Class I Medical device according to MDD? Can we continue to use our MDD significant change interpretation for the MDR as well? Yes. These aspects may appear on the device, packaging and in the IFU. Can you explain a little about the Eudamed unique Identification. 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