Is this address equal to the address of the Legal Manufacturer under IVDD ? Identify products that contain targeted substances per ECHA’s latest listing, Drill down to the smallest level of a device that falls in scope of the regulation, Centralize documentation and reports storage to quickly pull what you need, Proprietary AI technology aggregates and validates data. I have a question regarding your comment for ” Importer obligations”. 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. The EU has no intention to renege on previously certified devices when those were in conformity with the directives. MDCG guidance document 2019-11 should also help you to classify your device, if you decide that your software is a medical device. In the case of software, consider the intended users and whether or not the software function is intended to be used in making clinical decisions such as deciding whether or not to treat, diagnose or monitor the condition etc. 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. 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 manufacturer, you can, if you wish, add your importer’s name and address to your labelling, but it is not your obligation. Devices must be suitable for their intended purpose during normal conditions of use, Annex I(1). Regarding EU declaration of conformity ANNEX IV is it obligatory to list all the applicable harmonised standards to which the products comply or is it enough to include this reference ” all supporting documentation – including the list of applicable standards – is retained at the premises of the manufacturer and can be provided upon request”? Pay attention to the expiration date and check against the timeline specific to your product class (remember it may fall in a different class now). If a medical device requires installation or post-installation service/support, that should be included in the scope of the applicable quality management system. 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. Thankyou in advance. The requirements listed in Annex IV are the minimum requirements of the EU declaration of conformity. Thank you for your question about the languages needed for instructions: As you point out, Article 10(11) “Manufacturers shall ensure that the device is accompanied by the information… in an official Union language(s) determined by the Member State…” is a significant change from Article 4(4) of the MDD “Member States may require the information… to be in their national language(s)”. 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. If that is the case, they can continue to be made available to other distributors or to end users until 27 May 2025. EU MDR’s active Article 10 (11) “Manufacturers shall ensure…” the information accompanying the device is in national language(s). The guidance MDCG 2019-8 includes useful hints, which will help the manufacturers during design of an IC. Is the device a single-use device? The formal PMA study only captured performance of certain codes, but all product codes share the same basic science, same software, same hardware, and the same performance measures. 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? A similar question is, can importers also be distributors? That would give us 1-3 months extra to update the documentation to MDR. The manufacturer has to decide the intended use and to specify the intended use in the instructions and in the technical documentation etc. But a final draft version is being commented on and so it should be published soon. In short; a clinical investigation is not an automatic requirement, even for Class III devices. Thank you for your question about the European UDI format: In June 2019 the European Commission published IMPLEMENTING DECISION (EU) 2019/939 designating four entities to assign Unique Device Identifiers (UDIs) for medical devices for the European market. Thank you for your question about parts or components. Post your frequently asked questions below. EU MDR Timelines . Does that mean all authorised representative contracts need to be revised to MDR requirements by 26 May 2020 for legacy MDD devices? Or is the Article 4(4) of the MDD “Member States may require the information… to be in their national language(s)” still valid? Alternatively, if you choose not to take advantage of Article 123(3), you have the same option of following Article 120(4) as the class I device manufacturer and placing additional devices on the market until May 26th, after which they can continue to be put into service until May 2025. We’re trying to understand/determine the economic operator responsibilities in the supply chain, Thank you for your question about importers and distributors. Does “change your distribution model” in your answer mean that for example, ‘we choose one importer and make the others as distributors’? Annex I Section 23, on labels and instructions, requires that “Labels shall be provided in a human-readable format and may be supplemented by machine-readable information.”. Your devices were placed on the market according to the MDD, which didn’t address maintenance activities. 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. We make compliance easy, affordable, and timely. See the Commission’s “Blue guide” for more information. 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)? With Source Intelligence’s EU MDR program, we take the heavy lifting off your shoulders and make it easy for suppliers to provide the data and documentation you need. Just to clarify we are not reprocessing single use devices, they are instrument trays that are sterilised between operations, which we are processing for our own hospital Trust. The complexity of MDR necessitates that the transition span over several years, although high-risk devices (Class III) must meet compliance earlier. 3. Thank you for your question about the importer’s requirements. That only happens if they are “fully refurbished”. Progress report from the European Commission. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the … Thank you for your question about discontinued devices. Thank you for your question about the postponement of the date of application. Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020. >>> link here <<<. Thank you for your question about MDD compliant devices after 26 May 2020: MDD compliant devices (regardless of having a NB certificate or not) which are placed on the EU market prior to 26 May 2020 may continue to be made available on the market (i.e. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Thank you for your question about classification rules: Annex VIII, 3.5. says “If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device’s intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.” If, however the manufacturer cannot decide the appropriate classification, they (or their authorised representative) should contact their competent authority and request a classification decision (Article 51, 2). For clarification: Manufacturers of legacy MDD devices may still place those legacy devices on the market after 26 May 2020, but only on the condition they comply with the EU MDR Articles 29 and 31 on “registration”, Articles 83, 84, 85 and 86 on “post market surveillance”, and with Articles 87, 88 and 89 on “vigilance”. ; Obligations which they didn’t have under the MDD. New EU MDR/IVDR Legislation ... and entered into force in May 2017 following publication in the Official Journal of the European Union. I have a Class II device that is MDD certified that we’ve decided to discontinue manufacturing and selling prior to our MDD certificate expiration. That means, for the legacy (MDD) Declaration of Conformity and legacy (MDD) EC certificate to remain valid, the device itself must continue to conform to the MDD, including Annex I of the MDD. An industry association would typically be the best forum in which to reach a consensus position for a specific group of devices. >>>> link here <<<<. As a result, MDR may be qualified as one of the most complex sets of requirements for medical devices to date. After May 2020 can we consider this stock to be classed as ‘placed on the market’ and continue to sell it freely. The EU MDR does not define the traceability requirements for the health institutions or healthcare professionals that use devices. Possibly you only consider them to be distributors, but they are importers, already today. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device. Let’s start with the initial importation process. Regulation (EU) 2020/561 of 23 April 2020 amended the date of application of the EU MDR to 26 May 2021. This could be very challenging as, being reusable, we will have to mark directly the pieces. start citing MDR within docs) even though they are not yet certified and won’t be up for recertification until a year after the MDR goes into effect? Please consult the European Commission website for the latest guidance. 1: Selection and control of suppliers are recognized in the MDR as a component of resource management; therefore, resource management activities should include suppliers. Thank you for your question about the scope of the EUMDR. If after May 2020 your company continues placing devices on the market on the basis of an MDD certificate, they must remain in compliance with the MDD. However, the timeline for changing the number can usually be negotiated and agreed with the Notified Body concerned. 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 clinical investigation authorisations. Annex VI, part C, point 3.6 quote “Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.”. 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? In brief: If there is a withdrawal agreement, your company can continue to place its devices on the EU market after the Brexit date on the basis of their UK notified body certificate, until the end of the withdrawal agreement. It can influence not only the scope of your pre and post market clinical activities, but also the approaches related to UDI assignment, scope of technical documentation, the declaration of conformity and the registration. 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”. If there is no source of energy the device is unlikely to be an active device. 29-31), vigilance (Art. To your last question, no, an importer must be established in the Union. Thank you for your question about labels. If EUDAMED is not ready by May 2020, economic operators will be allowed 24 months from the date when EUDAMED is ready. Article 120(3) does not apply to such devices. Do we need to submit clinical trial data if MDR requires clinical trial? Can an entity act as Authorised Representative, Importer and Distributor at the same time? Thank you for your question about repacking damaged goods. I know the requirements for the IFU and labels, but are there any specific requirements for the QMS? No. We are non-EU manufacturer and we have distributors in each countries in Europe. Furthermore, the new EU MDR Annex I (23.1) also requires the information accompanying the device to be made available via the manufacturer’s website. While the directives classification system remains in application, several changes and additions have been introduced. 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. “any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis”. Although devices already placed on the market, i.e. further distributed, sold etc.) You can find there several .xsd files together with the note “for implementation in manufacturers databases before January 2020”. My question is specific about implications of such MDR in the service perspective: Any limitations on amending legacy MDDs certificates most likely come from the Notified Body’s own internal procedures, or agreements it has made with its Competent Authority or the Notified Body Operations Group. Thank you for your question about labelling. When a Notified Body that was previously certified under MDD is designated under the MDR will their Notified Body # change? All other types, not used on the patient, will be resterilized again for the next surgery. Thank you for your question about identification and traceability in health institutions. Is there really any rush to make the 2021 MDR deadline? or put into service (i.e. The EU MDR 2017/745 has 4 main categories for Medical Devices classification:. Article 120 only mentions certificates issued by notified bodies. Article 11 provides the medical device importer with additional details which must be included in his conformity verification. The MDR's usability requirements in detail. It consider that it is not a significant changes” as stated in Article 120(3) because this change don’t affect the product conception and the intended use. Which requirements apply to your company depends on the role the company has, manufacturer or importer. If your company was already compliant with the Medical Devices … . After that date they can continue to be made available on the market via distributors, or put into service by users, until 27 May 2025. it is clear about the implications of the MDR2017/745 upon May 25th, 2020 when we think about Quality Management System, Product Registration and so on. Your importer does, as you say, have an obligation to verify your compliance with certain obligations. Any labeling errors can impede the … Thank you for your question about clinical evaluation. 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. To know if your Notified Body’s number is likely to change, ask your Notified Body’s representative or account manager. The notified body is required, by Annex XII, to include on their certificate “data needed for the unambiguous identification of the device or devices where applicable..”. However, a device can only conform to either the MDD or the EUMDR. mdr@argosmultilingual.com +1 (303) 516-0857 (US) +353 1 503 0978 (EU) First Name * Resource management is also addressed with management review and includes the resources, including … 26th May 2021: Date of application of the EU MDR The concept of importer is not new and is not unique to medical devices. and question number 02: If I make to amend the labels can this be a soft switch (continue selling and exhausting all existing labels, while simultaneously placing/replacing with the new labels) OR I must do a hard switch? Hello, The type which is used is selected during the surgery, however multiple types are available sterile in the sterilisation tray during the surgery (however not used/in contact with the patient). I understand that we take multiple instruments to form a tray used in a specific procedure and therefore are ‘device manufacturers’ so I assume we would just register the tray? In practice empty barrels of syringes and rubber stoppers are manufactured by different manufacturers. Annex II, 1.1 a, c, d, etc.) You are referring to Article 62. Yes, and you should take a proactive approach regardless of the time the transition allows. Thank you in advance. 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. MDCG guidance document 2019-11 is intended to help manufacturers such as yourselves, decide if their software is a medical device or not. an implant, the vigilance obligations still apply. Rubber stopper / component itself is not a medical device. Thank you for your question about post installation servicing. 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 yes are the updates reflecting MDR requirements? – manufacturer choose to be certified by NB to increase market credibility Are there any exceptions for a (MDD) Notified Body approved class IIa product that will fall within MDR Article 1(6)h, or are the Article 120 transitional provisions fully applicable? 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. This is particularly important for any EU-based manufacturers that plan to enter other international markets. Also, some consistories are still under consideration. 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; When the transition period ends on 31 December 2020, a UK manufacturer will no longer be considered an economic operator according to Union legislation. 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. The delay to the date of application does not remove the possibility to comply with the EU MDR earlier than the date of application. 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. A few months ago, we wrote about the regulatory requirements of distributors under the MDR, in a post which describes how the Medical Device Regulation (MDR (EU) 2017/745) introduces significant requirements for economic operators of the entire supply chain of medical devices, including distributors. Thank you in advance. Regulation (EU) 2017/745 The European Union Medical Device Regulation of 2017 If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply. 1. Then and only then, they can draw up a declaration of conformity before applying for CE marking. According to Annex XIV 1(b), the starting point for the appraisal of clinical data is a systematic scientific literature review. 4 – Finally, decide the risk class and document the justification for the classification rule(s) considered applicable. 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 ? According to 23.1, it requires the information accompanying the device to be made available via the manufacturer’s website. not expired). EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8: What Has Changed? Hi! 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? –> I have no idea Medical device manufacturers have to write IFU in 24 EU offical languages The MDD did not say anything about this topic and neither does the EU MDR. 3. Devices that were previously certified under the MDD will need to be recertified to meet the new requirements of the EU MDR. 1. They also said that having close communication with one importer avoids confusion than several importers in Europe. Article 11 of the EU MDR is restating Article R4 of DECISION No 768/2008/EC, a common framework for the marketing of products. Medical device manufacturers or distributors are not necessarily big entities that can dedicate large teams to compliance. The EU MDR outlines the requirements of the “person responsible for regulatory compliance.” They must have a relevant degree or sufficient work experience to understand and meet the requirements of the standard. does all medical devices manufactuers outside EU will be required to have a authorised representitives? Is it compulsory? That said, it seems likely that all importers will be distributors, simply the first distributor in the supply chain within the European Union. Q. Yes. Thank you for your question about a PSUR template: No, at least not as of March 2019. The definition of “active device” is found in Article 2 (4). If the device was placed on the market according to the MDD then MEDDEV 2.12-1 rev. More specifically, this part: “Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.”. 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). We have some class I devices that we manufacturer outside Europe. The requirement is the same for every EU member state. There is no EU specific guidance on the topic of labelling. Please refer to the European Commission guidance on this topic. 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 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. A Medical Device is manufactured and sold under MDD with one notified body number (engraved on the product). 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.” But if you and your notified body have been following the guidance of MEDDEV 2.7/1 rev. 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. Article 11 of the EU MDR is restating rules which have existed since 2008. We will discontinue the product once stock runs out. Class II or III) from those that are not (i.e. But those are additional obligations relate to the manufacturer’s QMS. 2016/C 272/01). This device will not be recertified to MDR. However, Article 61 also says it is for you as the manufacturer to “specify and justify the level of clinical evidence necessary…”. There is nothing to prevent it. Thank you for your feedback and for your question about commercial practices. 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. 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. 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? There is no confusion that syringe is a medical device. Thank you for your question about Authorised Representatives and importers. 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