The European Commission’s Document Room posts version 7.1 as the new MIR form, and it already includes section for UDI, which we all know is required under the new EU MDR. Meaning, the QMS principles of plan-do-check-act can and should be applied to service activities in the same way as to production activities. Implying that the Article is probably not intended to be interpreted as applying to suppliers of parts and components in general, only those specifically intended for use in a medical device. Probably the only document that needs to directly reference the EUMDR is the EU Declaration of Conformity. 2016/C 272/01). The latest date for placing such MDD Class I devices on the market is 25th May 2020. Thank you for your question about importers. But a physical transfer of goods without transferring the ownership, would not constitute placing on the market. There are several conditions associated with Article 120 which are dealt with elsewhere on this site and in other Q&As. As defined earlier in Chapter 1 Article 2 (13) ‘label’ means the written, printed or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices; New Labeling Requirements – EU MDR Per the EU MDR regulations (Article 23.1, Chapter III of Annexure I), information pertaining to identification of a device, its manufacturer, relevant safety and performance information should be accompanied on the device. These Reusable Products are classified under Rule 6, Class IR (Surgically Invasive), These Single Use Products are classified under Rule 6, Class IIa (Surgically Invasive). Are Software companies required to translated their User Interface if they are classified as class III? 87-89) and post-market surveillance (Art. i.e. This is correct. Making changes to legacy devices is still possible after 26 May 2020, including potentially to the labels and IFU. The device is available in a number of types/configurations, depending on the patient, one type is used. Or the requirements in (23.1) just necessary for MDR compliant device? Thank you for your question about certificates. Concerning the terms or limitations of distribution agreements, you are recommended to consult a suitably qualified lawyer. Thank you for your question about software classification: Concerning the fertility status app: One would have to know the intended purpose of such an app, but it seems unlikely that it would be intended to make “decisions with diagnosis or therapeutic purposes” which is the main qualifying criteria for devices to be in class II or III. –> I have no idea Medical device manufacturers have to write IFU in 24 EU offical languages As far as the UK is concerned, the current position of MHRA can be found at the link below: https://www.gov.uk/government/publications/single-use-medical-devices-implications-and-consequences-of-re-use. Regarding the above, how about if we still have product in the field that we would continue to be responsible for repairing in regards to vigilance? The requirements for the Manufacturer’s Quality Management System (QMS) are contained in Article 10, 9. The date of publication was 24 April. mdr@argosmultilingual.com +1 (303) 516-0857 (US) +353 1 503 0978 (EU) First Name * It’s maybe worth restating that the classification of any device, including software devices, should not be performed in isolation. Does the EU committee publish the latest information which shows the counties accept other language(s) than their official language? The regulatory status of accessories in the EUMDR is the same as it was under the MDD. 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. Concerning the four UK Notified Bodies, who are reportedly planning to transfer their Certificates to offices in the EU-27 in the case of a no-deal Brexit, it is anticipated that their Notified Body numbers will change if there is no Brexit agreement. The year 2020 was already going to be an “exciting” one for medical device companies, thanks to all the regulatory and standards changes with the new EU Medical Device Regulation (MDR) as well as ISO 10993-1, ISO 10993-18, and even ISO 18562, pointed out Matthew Jorgensen, PhD, DABT, senior chemist and toxicologist for Nelson Laboratories. 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 … Given that this verification concerns documentation, not product testing, there would seem to be no reason why an importer should need to have physical possession of the devices concerned. However, it doesn’t know if our next audit can be made according the MDD directive because, it doesn’t know if it can make an addendum of this certificate (situation described in the document “Joint Industry Position on Significant Changes According to MDR Article 120(3)” –> However, these non-significant changes may require an amendment of the existing valid AIMDD or MDD certificate, to reflect properly the actual status of the device or manufacturer after the change). Thanks. PBT; vPvB, endocrine disrupting properties) Assuming they are not medicinal substances, devices composed of substances, or combinations of substances, would most likely be classified using Rule 21. 83-86). This is explained in Article 120, para. Answer: Yes, in October 2018 the EU Commission published; the current MDR and IVDR implementing measures rolling plan, which includes the list of implementing acts to be published, and an updated state-of-play of joint assessments of Notified Bodies in the medical device sector. Does that mean all authorised representative contracts need to be revised to MDR requirements by 26 May 2020 for legacy MDD devices? Concerning the UDI requirements: The Medical Device Coordination Group Document MDCG 2019-5 makes clear that the UDI requirements in Regulation (EU) 2017/745 do not apply to legacy devices. ; In referencing version 7.2, the new additional guidance on MEDDEV 2.12/1 rev.8 (published in July 2019) appears consistent with the MEDDEV Guidance page. Concerning post market surveillance documentation, EUDAMED will be used only by manufacturers of class III and implantable devices to upload the PSUR for evaluation by their notified body. Questions about the scope of EU law should be addressed to an appropriately qualified lawyer. Moreover, from what you answered previously, I guess that importer does not need to provide the goods but just verify the conformity (documentation and data entries) of the goods. A manufacturer must not supply a device to anyone within the EU if the MDD certificate for that device has expired. Thank you for your question about the human readability of information. . 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? The obligations of importers are not exclusive to medical devices and they are not new. This is also stated in the preamble, whereas (81). Can a Manufacturer expressly forbid passive selling by a Distributor in order that the Manufacturer not run the risk of their device being sold in an EU country without being in conformity with any local language requirements of that country? What should the Healthcare organization’s supply team (ERP-team) do to prepare for MDR and 26th of May 2020? Sponsors and investigators are additionally expected to follow ISO 14155 on good clinical practice for clinical investigations of medical devices for human subjects (Whereas: 64). There is however guidance from IMDRF/GRRP WG/N52. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. Answer: Yes, the European Commission has published a Fact sheet for Manufacturers of medical devices, a Step by step implementation model and an Exhaustive list of requirements for manufacturers of medical devices. But if you want to be more specific, we can say that there are 3 sub … Thank you for your question about discontinued devices. In this post I want to focus on cybersecurity requirements related to EU MDR. We use standard product labelling for all our EU countries where we sell. Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices. This option is not available to (MDD) Class I devices, the so called “self-declared” devices. Great! I know some countries accept English in stead of their official languages, especially for a professional use. Thank you for your question about clinical investigations involving CE marked devices. Under the new European Medical Devices Regulation (EU MDR 2017/745), CERs will be required for all classes of products. The need, or otherwise, for a clinical investigation being determined by the outcome of the clinical data appraisal. 3 – Next, decide and document the rationale why the product qualifies as a medical device – not all software used in the health and wellness arena fulfils the definition of a medical device as the examples on the FDA website illustrate; If a distributor is unsure of the language requirements applicable to a legacy device they are distributing, they can enquire of the manufacturer or their national competent authority. If a distributor wants to place an MDD certified (legacy) device on the market after 26-May-2020, should he verify that the labelling and IFU of that device is in an official Union language(s) determined by the Member State? After conformity assessment and production start there will presumably be, in the production records, a list of the actual UDI-PIs. What is the highest level of packaging in the case of manufacturing dermal fillers for example? MDR (EU 2017/745) and IVDR (EU 2017/746) cover only Human Health SVHC based on human health hazards are exempted from authorisation requirements Environmental hazards still fall under the scope of REACH SVHC based on environmental hazards are not exempted from authorisation requirements (e.g. PBT; vPvB, endocrine disrupting properties) According to paragraph 2 of article 123, the date of application or mandatory implementation date of the regulation is 26 May 2020. September 2017 update of EU MDR regulations includes Base-UDI procedure. Thank you for your question about maintenance activities. Thank you in advance, For example, many devices not covered by the previous European Medical Device Directive (MDD) requirements now fall under the MDR, including certain accessories, services, cosmetic devices and device-specific cleaning products. Given that the PSURs for such devices have to be produced/updated annually, it seems reasonable to expect that the first PSUR uploaded to EUDAMED will be in May 2021 for legacy MDD devices, or for EU MDR compliant devices one year after the first device was placed on the market. Please consult the European Commission website for the latest guidance. The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.. All codes have bench and animal data supporting consistency of performance. The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. Concerning Switzerland, additionally there is the EU-Swiss mutual recognition agreement on conformity assessment which includes medical devices. Appreaciated for your reply! I am concerned that products once “placed on the market” will be changed to “NOT placed on the market” due to changes in the interpretation of the regulations. Thank you for your question about authorised representatives. While fulfilling the requirements of an ISO standard will likely be almost the same as fulfilling a European standard. If your product fulfils the definition of an “accessory for a medical device” given in Article 2(2), according to Article 1(1), the regulation applies and all of the requirements applicable to devices apply to your product, including the UDI requirements. Can you hold a CE MDD and a CE MDR certificate for the same device from two different Notified Bodies? According to Article 120 (2-4), an additional conditional transition period is possible, but only for devices which still have a valid (MDD) Notified Body certificate in May 2020. 120 (4)). However, concerning devices already placed on the EU market before Brexit, they can continue to be put into service until 27 May 2025 (depending on shelf life). New Labeling Requirements – EU MDR. Could there have been a typo error on the Guidance document, where it says that the updated version of the MIR form that will become mandatory from January 2020 is version 7.2 ? Hi, Bids are often for sales > 1 year in the future and include software/devices still in development. 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)? How can importers verify those requirements without physical possession of the devices. Yes. Regarding passive sales by a Distributor, does the ultimate responsibility for adhering to the local language requirements of an EU country always rest with the Manufacturer? Given that there is no qualification on when the device being repaired was put first into service, it follows that the article applies to parts and components intended for any medical device which is still in service, regardless of when it was first put into service. Roles like Importer and Distributor and activities like making available on the market are not exclusive to the medical device and IVD sectors. 1. A gap analysis or Biological Evaluation Plan gives companies the chance to “review all information and . Only with a certificate issued by an EU-27 notified body. Please keep in mind that the requirements of the MDD or EU MDR apply to individual devices, not to types of devices. Hello, Due to the extension of the MDR for one year, labels IFU’s etc have already been completed for Class I devices’s, although the DoC has not been completed and signed to the MDR is it illegal to have the MD symbol on the labels with explanation in the IFU DoC signed off under the MDD. How about accompanying multi language IFUs? Information on the Label; “(d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative.” what is the definition of the “Union” here? 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. Are these then seen as separate and individual “labels” – i.e. Thank you in advance. 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. Only devices placed on the market in compliance with the MDD “by virtue of”, or on the basis of, a Notified Body certificate are eligible for the additional transitional period. 1. When the transition period ends on 31 December 2020, a UK manufacturer will no longer be considered an economic operator according to Union legislation. You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51). If seen as individual items, then I would assume each ‘label’ should contain as much content as required to meet the Regulations set forth in 23.2? Can you explain a little about the Eudamed unique Identification. But that’s really as much as is said about claims and promotional material in the EU MDR. Is it acceptable to use a QR code to identify the importer information on the product? If a clinical investigation is planned to further assess a device which is already CE marked and is within the scope of its intended purpose, it is referred to as PMCF (Post Market Clinical Follow-up) investigation. Thank you for your question about re-processing of single use devices. Importers do not release devices as manufacturers do. Device name which is not trademarked or registered needs to be translated or not in the label. See the Commission’s “Blue guide” for more information. MDR and IVDR implementing measures rolling plan, state-of-play of joint assessments of Notified Bodies in the medical device, Fact sheet for Manufacturers of medical devices, Exhaustive list of requirements for manufacturers of medical devices, “Blue guide” on the implementation of EU product rules, HPRA, the Irish Competent Authority, has also published a very comprehensive guidance specifically for distributers, https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en, https://www.kitozyme.com/en/healthcare/gastrap/. Where can I find this in the regulations? Through a user-friendly and ergonomic interface, you can: Because EU MDR focuses so heavily on supplier documentation, the stronger your relationship with your suppliers, the better. Where can I find information about Base-UDI (for product families)? There is no EU specific guidance on the topic of labelling. Hello, This is Kim from South Korea. Regulation (EU) 2017/ 7 45 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area. >>> link here <<<. You don’t need to do anything additional for such devices. Thanks in advance for your clarifications. Despite the delay of EU MDR into May 2021, some organisations are still burning valuable time in terms of updating the labelling and instructions for use (IFUs) of their medical devices. Considering this, each distributors can be provided with the goods from manufacturer not through importer. There are exceptions or derogations for quite a number of Articles listed in paragraph 3, but Article 11 on the Authorised Representative is not one of them. However, Article 61 also says it is for you as the manufacturer to “specify and justify the level of clinical evidence necessary…”. Alternatively, if a clinical investigation to further assess a device which is already CE marked would be outside the scope of its intended purpose, the sponsor must follow Articles 62 to 81. device label(s), packaging label(s), etc. Where can device manufacturers find guidance on what are considered “significant changes” as stated in Article 120(3)? The EUMDR also allows Manufacturers and Distributors different options: Article 23(1) allows in; (d) for Class I and IIa devices to be supplied without instructions if the device can be used safely without them, (f) the use of non-paper formats, (h) the use of internationally recognised symbols. Do we have to write the IFU in 24 EU offical languages? The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. In case of repair of one product sold before the transitioning (i.e. As you wrote, the Article 120(3) transitional provision for legacy (AIMDD/MDD) devices applies to devices which, under the EU MDR, require the involvement of a notified body. We make compliance easy, affordable, and timely. Hi, – manufacturer choose to be certified by NB to increase market credibility As a medical device distributor your company is responsible for its own interpretations of the regulation. Does “change your distribution model” in your answer mean that for example, ‘we choose one importer and make the others as distributors’? In other words, companies placing medical devices on the European market are held responsible for their devices and must be able to demonstrate financial coverage in case a defective device is responsible for causing harm. to the Article 13 “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be The Blue guide says “An offer or agreement concluded before the stage of manufacture has been finalised cannot be considered as placing on the market..”. Thank you for your question about Article 16. Any labeling errors … These aspects may appear on the device, packaging and in the IFU. Thank you for your question about the transition period. What type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR? The manufacturer decides whether and when a specific device complies with the MDD or the MDR and maintains the Declaration of Conformity for the specific device to reflect this. Thank you for your question about repairs and notified body numbers. The obligation of importers to indicate their name and contact address on the packaging, or in an accompanying document, is not new. I need certain information about transition period of Class I medical device. All the other distributor obligations are independent of whether the device is a legacy or MDR compliant device. Is the manufacturer and/or depot distributing the investigational device to clinical sites required to have a Qualified Person responsible for QP certification similar to clinical investigational medicinal product (IMP)? The distributor has the explicit obligation in Article 14, 2(b) to verify compliance with Article 10(11). Thank you for your question about significant changes. Per the EU MDR regulations (Article 23.1, Chapter III of Annexure I), information pertaining to identification of a device, its manufacturer, relevant safety and performance information should be accompanied on the device. They will also be registered in EUDAMED as a “legacy device”. In this post I want to focus on cybersecurity requirements related to EU MDR. General Key Dates . (a), as long as you enter into an agreement with the manufacturer, whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in the Regulation. However, Annex II only requires Basic UDI-DI to be listed within technical documentation. The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). 2. Thank you for your question about the obligation in Article 10(11), to ensure the device is accompanied by information in the official language(s) of the Member State in which the device is made available. Or is there an MIR version 7.2 that’s yet to be published? The date of application of the Medical Devices Regulation has now postponed until May 2021. Thank you for your question about clinical evaluation. The post EU MDR Approval: Performing the Literature Search appeared first on MedTech Intelligence. Thank you for your question about Brexit. The classification is primarily determined by the intended use of the device and is generally independent of the technology involved. You also have to control risks, Annex I(4), which might necessitate training users, and to eliminate or reduce risks related to use error, Annex I(5). Article 120 only mentions certificates issued by notified bodies. Whereas Article 13 is an obligation of importers. 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