The manufacturer must also comply with the new EU MDR requirements for post-market surveillance, vigilance and registration. You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51). FDA has also published a list of examples of medical device software functions which FDA considers to be low risk. What are the liabilities that imply? Can you please provide guidance on this scenario: Both topics are worthy of a FAQ once more information is available. What do you need to provide, because it contains also propriatery information that you don’t want to share. New EU MDR/IVDR Legislation ... and entered into force in May 2017 following publication in the Official Journal of the European Union. Distributors make devices available which have already been placed on the market by the manufacturer (or importer). Thank you for your question about post installation servicing. If EUDAMED is ready before May 2020, economic operators will be given 18 months to register the details of their devices in the database. Probably the manufacturer’s name and address cannot be translated. We are a Non-EU manufacturer and have 14 distributors in Europe, all of which are also importers of our product. This is explicitly stated. 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. The MDCG has endorsed quite a number of guidance documents on UDI. It depends what is claimed on the Declaration of Conformity, 93/42 or 2017/745. Section 20.2. For a full definition of the applicable geographies, please read the European Commission guidance, the “Blue guide”. The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. Is it true that NB-MED/2.12/Rec1 “PMS” and/or MEDDEV2.12-1 “Vigilance” are currently updated? Is the Importer different than the distributor or can be the same company? That implies their quality management and technical documentation is already EUMDR compliant, even though they are continuing to place devices on the market with MDD certificates. newly manufactured, a new notified body and new certificates will be required. i.e. Importers do not release devices as manufacturers do. There is one item which is not applicable to legacy devices, legacy devices are not required to have the UDI (Article 13, 2(d) and Article 14, 2(d)), but the manufacturer should inform the importer or distributor about that in the course of the verification. I know the requirements for the IFU and labels, but are there any specific requirements for the QMS? More specifically, if your devices are re-certified under the MDD can you submit a new device technical file for review under the MDR or does that trigger a full blown transition to MDR? Hi, Thank you for your question about harmonised European standards. There are 23 articles in the MDD, while in the MDR there are 123 articles. Under the new European Medical Devices Regulation (EU MDR 2017/745), CERs will be required for all classes of products. They are parts or components. All companies producing medical devices destined to the EU must name a person solely responsible for regulatory compliance. Source Intelligence has developed a solution to automate and simplify data collection and reporting. We have some class I devices that we manufacturer outside Europe. That would give us 1-3 months extra to update the documentation to MDR. What obligations does the distributer have that imports the product back into EU – will they become an importer -as the products already are made available in EU by the manufacturer? According to Article 16 1. However, Annex II only requires Basic UDI-DI to be listed within technical documentation. 1: Selection and control of suppliers are recognized in the MDR as a component of resource management; therefore, resource management activities should include suppliers. Hello, Manufacturers must decide in which Member States they intend their device to be available and in which languages the instructions need to be made available. Thank you for your question about Annex I 23.2, the information required on the label. Thank you for your question about the transition period. (thus class IIa) they will share the same technical documentation, clinical evaluation, notified body certificate etc. Yes. Possibly you only consider them to be distributors, but they are importers, already today. By Darragh McMorrow, May 30, 2019. But yes, this is the same name and address of the manufacturer as was previously required by Annex I of the Directives. Thank you for your question about the importer’s requirements. The fertility status of the current day is reflected by one of three indicator lights: red (fertile), green (infertile) or yellow (learning phase/cycle fluctuation). . Thank you for your question about technical documentation. My question is how Prebiotic based devices will be classified and regulated under the Medical Device Regulations. 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. An assembled syringe is only a medical device if it is intended by its manufacturer to be used for a medical purpose. The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). However, you are recommended to consult a suitably qualified lawyer as there are most likely other regulations to consider, for example customs regulations. Thanks for answering wide range of questions. In regards to 23.2 Label requirements. Currently, Manufacturer’s quality management system certificates should show conformity to EN ISO 13485:2016 + Annex ZB (MDD). Thank you for your question about labelling. Multiple UDI-DI can be assigned under one Basic UDI. These tasks are only the tip of the iceberg and each product may have it’s own unique sets of tasks needed as well. 3. – device is sterilized (Class Is), or measurement device (Class Im) My question is specific about implications of such MDR in the service perspective: 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. 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. And the bar for “equivalence” is so high as to be impracticable unless you yourself are the owner of the “predicate”. Although deadlines vary depending on the risk level – or class – of your device, and despite some items still not fully released, Notified Bodies will get swamped as organizations rush to meet due dates. Or is it just regarding the classification I to have an authorised representitives? If our distributors replace the labelling or package of the medical device due to they are in bad conditions, is it understood as a relabelling or repackaging of the device? However, these are not new roles and not new activities. Could you please clarify par. 87-89) and post-market surveillance (Art. General Key Dates . I would like to ask you a question, if I may. Language requirements for labels and instructions. The requirements for the Manufacturer’s Quality Management System (QMS) are contained in Article 10, 9. In short, this is very much a matter for the national Competent Authorities. Hello, This was not my understanding of it. The general requirement of Annex I Section 23(1) is that each device is accompanied by the information needed to identify the device, its manufacturer, and any safety and performance information relevant to the user. Can you clarify whether placing products directly on the EU Market as a UK based distributor is permitted, or does EU MDR make it a requirement for the manufacturer to appoint an EU based ‘Importer’ to fulfill this role? 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. As per Article 2.1 – Definition of Medical device: “medical device’ means any instrument, apparatus, appliance, software, implant, reagent, MATERIAL or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes”. However, this requirement is not mentioned under Annex I chapter III (GSPR). The EU MDR does not define the traceability requirements for the health institutions or healthcare professionals that use devices. 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? The EU MDR is concerned with the conformity of devices when the device is placed on the market (i.e. 2. but there is an issue at the IFU. 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. Yes. Article 58 says the manufacturer must have an agreement with the (new) incoming notified body. Let’s go through everything you need to know to be ready for the 2021 start date and beyond. Are there any dates relax (26th May 2020) for Class 1 medical device, considering the current Global Issue with Corona Virus? Thank you for your question about authorised representatives. The two regulatory systems are different. The complexity of MDR necessitates that the transition span over several years, although high-risk devices (Class III) must meet compliance earlier. It underwent fundamental revisions in 2017 to improve transparency through standard data, technological advances and the creation of an EU (EUDAMED) database. It is a case by case decision by the manufacturer. You answered to Terese on Dec. 9th, 2019 that “The condition, according to Article 120 (4), is that they are placed on the market prior to 26 May 2020. If your company’s Class I device is EU MDR compliant now, it can be registered now with your Competent Authority and it can be placed on the market now as an EU MDR compliant device. Thank you for your question about the new Manufacturer’s Incident Report (MIR) form: The current version of the new Manufacturer’s Incident Report (MIR) form is version 7.1. The additional five years conditional transition period #1, The additional five years conditional transition period #2. The condition, according to Article 120 (4), is that they are placed on the market prior to 26 May 2020. If we order 20,000 of these medical devices on 21 May and a further 20,000 on 21 June 2020 and these are manufactured in 4 lots i.e. 2 – Then define and document the principles of operation of the device (not technically but medically), and the mode of action by which the device achieves its intended purpose of diagnosing, treating or monitoring the medical condition in the intended patient population. 120 (3)). The general requirements for each overlap with each other and consist of the following: Devices must perform in a way that aligns with the intended design. (a) the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated; Does this mean, If we are only supplying devices within our own Trust and not providing a 3rd party service do we need to have MDR? Required fields are marked *. EU MDR changes are only the beginning – ensure IFU compliance now and be prepared for more to come . “MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. Please note: The term “software as a medical device” (SaMD) is not used in Europe. Your importer does, as you say, have an obligation to verify your compliance with certain obligations. When a device is discontinued from Market, but still few units are in Market. Thank you for your question about notified body numbers changing: If the number of a notified body number changes, it must also change on the labelling and instructions where it accompanies the CE marking. Generally speaking, an active device is one that depends on a source of energy. Annex I is an obligation of the manufacturer. Thank you for your question about importers and distributors of legacy devices. Please note that there are limits to the continued validity of NB’s MDD certificates, either 2022 and 2024, depending on the certificate type. What is the language requirement for the QMS? New guidelines to define cybersecurity requirements appeared, first by FDA and then by EU following the publication of EU MDR 2017/745. Article 120(3) does not apply to such devices. (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. According to media accounts there are manufacturers who are ready to submit applications under the EUMDR, but they cannot because of the lack of notified bodies. A similar question is, can importers also be distributors? Question: Is guidance on the new regulation available from any official sources? Do we need to submit clinical trial data if MDR requires clinical trial? How can importers verify those requirements without physical possession of the devices. The location of the distribution centre would seem to be irrelevant from the perspective of the EU MDR. Labeling requirements under the new MDR . However, it is the first EU based entity in the distribution chain that places the product on the EU market, not the third country supplier. As stated in the definition it is either one or the other. In case of an empty or pre-filled syringe, do the rubber stopper in the barrel of syringe also qualifies the definition of “accessory” as per MDR 745 and it is considered as medical device or not???? Annex II details what Technical Documentation is to be kept available for each device, but not how. It’s maybe worth restating that the classification of any device, including software devices, should not be performed in isolation. The best reference defining the different economic operators is the Commission’s ‘Blue Guide’ (2016/C 272/01). ; A UK based company cannot do that. Answer: Yes. Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. “. The EU MDR covers all items sold within the EU, but this does not mean that only EU member states need to fulfil the requirements. Particular attention shall be paid to: Answer: Manufacturers can continue to use their MDD Notified Body certificates, on condition they update their post market surveillance, vigilance and registration procedures to those of the EU MDR by May 2020. As I underestood, for active implantable devices, the UDI-PI shall include at least the serial number, for other implantable devices, the serial number or lot number. Concerning MEDDEV 2.12/1 on Vigilance, Rev.8 is still the current revision according to list of guidance MEDDEVS on the Commission website. Would it be possible if the class I products produced before May 26 2020 was placed at the distributors or at our sales offices in EU? For Class iii and implantables, I fully appreciate the reasoning behind this and the very restrictive articles 61(4) and (5). Also, regarding the labeling/IFU, you mentioned “no need to do anything additional” for the MDD compliant devices. Regarding “The additional five years conditional transition period #1” & “Article 16”. 8, 2013 together with the additional guidance issued in July 2019, still applies. if it means only the European Union members, for the manufacturers registered at Swiss, they need represetative. It is not prohibited and each role has their own specific obligations. What should the Healthcare organization’s supply team (ERP-team) do to prepare for MDR and 26th of May 2020? I understand some MDD Class I devices have CE certificates involving notified bodies, such as; Annex I of the EUMDR doesn’t apply to legacy devices. Please read EUMDR Article 120(4). Thank you for your question about the language of the QMS. Your Notified Body is the best organisation to answer your question. Thank you for your question about the transition period for MDD Class I devices: The “Transitional provisions” of Article 120 are not available to MDD Class I devices because they don’t have a Notified Body certificate. In MDR we use same classification for these devices? This device will not be recertified to MDR. EU MDR directive and its requirements, please reach out to us by filling in this form. Can a company begin updating and implementing quality processes, WI’s, checklists, tech files, eIFU’s et cetera now, to include MDR requirements (e.g. 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). Hello, we are a UK device manufacture, we have a product which is covered by MDD. How to maintain compliance? Until then, the regulation provisioned for. The process of implementing this new EU directive started in 2017, with it scheduled to come into force on 26 May 2020, i.e. You don’t need to do anything additional for such devices. Thank you for your question about certificates. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. It seems that an importer should NOT need to have physical possession of the devices. Specific EU MDR 2017/745 requirements for device importers and distributors. Can you have both an MDD and an MDR certificate at the same time? I am aware Probiotics are no longer under the scope of MDR. We are a sterile Services department sterilising instrument trays between uses. You are recommended to consult MDCG 2020-6 “Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC”, as this guidance was developed specifically to assist manufacturers and notified bodies with these questions. General Key Dates . The EU MDR 2017/745 has 4 main categories for Medical Devices classification:. 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/. I am exploring the options for obtaining this aforementioned certificate from a notified body. The requirements are intended to ensure that different controls are carried out throughout the process of placing a device on the market, with each entity serving as a control on the others. I have additional questions, regarding your comments “Devices coming from non-EU manufacturers may have more than one importer”. Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, published at the beginning of May. 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 … There are conditions: Not only must the manufacturer have a valid MDD certificate for the device. Although whether the physical transfer takes place before or after the legal transfer, would be a matter for the parties involved. 83-86). Or is the information required to be human readable? In addition, eIFU can not be applied for our product because our product is NOT “fixed install medical devices” and does not have a function to display IFU. I have a question about classification of the products. How would you solve this issue? Where can device manufacturers find guidance on what are considered “significant changes” as stated in Article 120(3)? Hi, But our MDD certficate is valid until 05/2020 and certified by UK Notified Body, and the Brexit will happen on 30/10/2019. Thank you for your question about the amended date of application. I am impressed how good your control with the information/news and forum is. or as holistically as a single ‘label’? Thank you for your question about repacking damaged goods. Our supplier has ceased providing parts, so we placed a final order and manufactured two years of stock. Or is there an MIR version 7.2 that’s yet to be published? But if you want to be more specific, we can say that there are 3 sub … For example, if I self declare prior to May 26 2020, do I still have the same 5 year transition period as devices that receive MDD certificates prior to May 2020? Will MDR Transition still imply? 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. (Note: The debate starts at time 09:00 with Commissioner’s responses at time 09:05-09:11 and time 09:56-10:01). Here are the tasks you need to include in your action plan: Define your product classification based on the intended purpose. But distributors are not required to review the technical documentation. 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 ? 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? The type device used on the patient shall be discarded (disposed). Great! The manufacturer has the obligation to ensure the device is compliant when it is placed on the market. There are always two certifications to consider: The Quality Management System certification of the Manufacturer and the CE (notified body) certification of the device. Assuming the data for those codes studied under the PMA is valid to support EU MDR submission, and the bench & chronic animal data exists for all codes, would additional clinical studies be required for each code to be registered in the EU? 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. There is no mention of device classification. Thank you for your question about marketing materials: If by “leaflets” you mean the mandatory information that must accompany the device, the “instructions for use”, their content is specified in Section 23.4 of Annex I. MDR defines distributors as any entity within the supply chain other than the manufacturer or importer that makes the device available up until the point of placing into service. That topic would typically be addressed in national guidelines issued by the national Competent Authorities. 4. In that case you don’t have to adopt the approach of the questioner with the class I device. Is it acceptable to use a QR code to identify the importer information on the product? 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. 1 – First define and document the intended patient population and medical conditions to be diagnosed, treated and/or monitored by the device; Not in the MDD nor in the EU MDR. If the device has already been placed on the Union market, and the distributor is an entity established in the Union who makes available the device to other distributors or users established in the Union. less than a year from now. This MDSW app should be classified as class I per Rule 11c.”. Their original EC Declaration of Conformity and NB certificates do not change retrospectively and they are not placed on the market again, even if they are repaired. This has a raft of implications for pharmaceutical and medical device companies in the UK & EU. If your company was already compliant with the Medical Devices … The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. Hi, or the importer’s information must be already put on the product/document when exporting the product to the EU? What does MDR mean under the shipping containers – carton box with some amount of the devices or freight metal containers? Some general surgery surgically invasive instruments are used in general surgeries and in open heart surgeries as well i.e. It has never been a requirement to have the address of the notified body on labels. 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. Bids are often for sales > 1 year in the future and include software/devices still in development. Thank you for your question about the date of application. It is help us. 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. Regarding Importer information on the product. In this post I want to focus on cybersecurity requirements related to EU MDR. Consulting: Our step-by-step instructions help to speed up your MDR or IVDR project immediately and we support you with our experiences, tools and additional checklists (not available online) to get a clear strategy. 1. The EU MDR does not address this topic specifically. In short; a clinical investigation is not an automatic requirement, even for Class III devices. Concerning the QMS, the EU MDR does not regulate the language used in the QMS documents. It is stated at Annex I, Chapter III, subsection 23.2. Class II or III) from those that are not (i.e. On other hand, “2.4 Placing o the market (P.19)” of ‘Blue law’ says “Placing on the market is considered NOT to take place where a product is : – in stocks of the manufacture or the importer , where the product is not yet available, that is, when it is not supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonization legislation.” They will also be registered in EUDAMED as a “legacy device”. This has a raft of implications for pharmaceutical and medical device companies in the UK & EU. Specifically, these new requirements are related to post-market importation and distribution activities of medical devices in the European Economic Area (EEA). For a summary of the current rules and definitions on placing on the market and importers etc., please read the European Commission’s ‘Blue Guide’ on the implementation of EU products rules 2016. 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