Thank you for your question about the language of the QMS. Hello, This is correct. We understand that a manufacture have to accompany information, which includes an IFU, in official language according to Article 10(11) . Thank you for your question about post installation servicing. My question is similar to that of @Terese, can I build up a safety stock and transfer ownership to the distributor? Isn’t ISO optional? Thank you for your question about importers and distributors. 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???? The condition, according to Article 120 (4), is that they are placed on the market prior to 26 May 2020. The European Medical Device Regulation (EU MDR) guarantees minimum safety and quality requirements for medical devices being manufactured or imported into Europe. The obligations of distributors are listed in Article 14: Distributors are required to verify some elements of the labelling and instructions as well as the EU declaration of conformity. 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 ? 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. This is where you can find answers to the most frequently asked questions. 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). PBT; vPvB, endocrine disrupting properties) Can we continue to repair the MDD-certified device and return it to the field after 26 May 2025? But it may be more appropriate to consider how the ownership of the product is moving across borders, i.e. Annex I is an obligation of the manufacturer. Both topics are worthy of a FAQ once more information is available. They have been in place since 2008. 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. Article 120(3) is addressed to manufacturers, Article 13(2) is addressed to distributors. Important to note however that this article applies to items “specifically intended” to replace a part or component of a device. (Note, we are not refurbishing, just repairing). The EU MDR does not regulate the operation you are performing. 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. This strongly suggests, together with the new guidance, that there will be a new, new Manufacturer’s Incident Report (MIR) form before the end of 2019. What is meant in Article 120, 3 by “the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives”. 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. As many legal manufacturers will have a grace period to bring their products into the market under MDR, does it mean that the importers and distrubutors are also covered under the grace period? Thank you for your question about former notified bodies. 7. This site uses Akismet to reduce spam. I have a question about requirements (23.1) in Annex I. 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? 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. Not only is the EU a hub for innovation, but it also has some of the most stringent laws regulating the medical technology sector. 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). I know the requirements for the IFU and labels, but are there any specific requirements for the QMS? I need some help regarding obligation of distributors mentioned in article 14.2. Due to Brexit, we are now registering for a VAT # based in the Netherlands. Thank you for your question about the date of application. The manufacturer has to decide what is appropriate for their specific device or devices. Concerning the (promotional) claims made for the device: In contrast to every other topic, the EU MDR doesn’t state what is required, only what is prohibited (See Article 7). It is a question for your new notified body what recognition they will give to the certificates of your previous notified body. Thank you for your question about distribution. 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? In this post I want to focus on cybersecurity requirements related to EU MDR. In practice empty barrels of syringes and rubber stoppers are manufactured by different manufacturers. In which case, your Authorised Representative will register your company in the EUDAMED “actor registration” module, and your third-party logistics provider will register as an importer. In case of uncertainty, this question should be tested in the risk management activities. My understanding was the MDD allowed this as long as the CE mark was approved prior to shipping into EU. A Medical Device is manufactured and sold under MDD with one notified body number (engraved on the product). Please see the earlier reply to Lee. Placing on the market applies to individual devices, not product groups or types. Article 11 of the EU MDR is restating Article R4 of DECISION No 768/2008/EC, a common framework for the marketing of products. I have a question regarding the importer symbol… if our importer does not carry out any tasks written in Article 16(1) and (2), does that mean we do not need to use the importer symbol per Article 16(3)? So, while an individual device cannot have two certificates, a manufacturer can hold several valid certificates concurrently. Currently, we are preparing for MDR certification. Thank you for your reply. Until when will the new versions become available? Thank you for your question about Importer obligations. When a Notified Body that was previously certified under MDD is designated under the MDR will their Notified Body # change? Thanks for answering wide range of questions. General Key Dates . That being said, this new law is far from being an overnight switch. Thank you for your question about the importers’ obligations. already in the distribution chain, will be unaffected. Is it acceptable to use a QR code to identify the importer information on the product? I understood the manufacturer must also fulfil the new EU MDR requirements for registration (Art. 26th May 2021: Date of application of the EU MDR 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)? 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 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. The additional five years conditional transition period #1, The additional five years conditional transition period #2. Or is there an MIR version 7.2 that’s yet to be published? but there is an issue at the IFU. Thank you for your question about the EU declaration of conformity. There is no confusion that syringe is a medical device. This is explained in Article 120, para. However, given that manufacturer and importer have a business relationship, they have the possibility to agree how the verification will be performed by the importer. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May. The latter. . Or we can produce and replace the component with one that has the MDR notified body number engraved? Monopolizing even a few of them to work on MDR full time is not an option: it would be too expensive and detrimental to core business functions. What would be the way to obtain such certificate? Thank you for your question about authorised representatives. The 2 years worth of stock on the shelf was manufactured pre May 2020 under MDD, and is ready for sale. But if your company already has a procedure based on the NBOG best practice guide, for deciding when to inform the notified body of planned changes to the product, you should continue to follow that procedure. An application to a notified body to assess technical documentation has no effect on the status of an already marketed device. In cases like above, can the certificate be valid until 27 May 2024 maximum? How to maintain compliance? 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. Is the device a single-use device? 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 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. In practice however, the new infrastructure required by the EU MDR; the new EUDAMED database, the new registration and reporting procedures etc., will not be put in place by the European authorities for several years and transitional arrangements will … Annex II details what Technical Documentation is to be kept available for each device, but not how. Labeling requirements under the new MDR . 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. You want to pay careful attention to devices that are attributed to higher risk scores (for instance from MDD Class II to Class III), Determine general design and safety requirements, Have a risk management system in place and specific risk control measures ready to be activated, Encourage early use of harmonized standards as best practice, List product characteristics and check against MDR to assess potential gaps, List chemical, physical and biological properties, Identify Substances of Very High Concern (SVHCs), Define the smallest level of an article you need to investigate, Gather all information necessary for technical documentation, Keep an eye on other legislation relevant to your devices (REACH, RoHS, Osha Machinery Directive), Ensure all technical documentation is available (your QMS will make a difference in accessibility), Design your post-marketing vigilance process and establish corrective action, Designate a mandate for authorized representation if your operations are outside of the EU, Gather information on your ability to financially cover liability issues, Appoint an MDR compliance-dedicated person to act as a central point and dispatcher for the project: data coming in, going out, timelines and regulation updates. 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