Home » Blog – Serialization & beyond » Regulatory Requirements » The Basics of the European Medical Devices Regulation (EU MDR). So first it should have an automatic readable part like a bar code and a human-readable part like numeric codes. Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization. This would help me to understand your situation. Surprise. You need a UDI-DI for each product. Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which … I offer you a Free Medical Device Regulation training course with a quiz and certificate of completion. And on this group, you have 3 categories of Hip Implants. Below are some other rules to apply for UDI on a software. The other resource that you can check is the, Summary of safety and clinical performance, Let´s continue with hip implants. He proposes his consulting services so don't hesitate to contact him at [email protected] or +41799036836 This element will be key for the traceability of devices in Europe. So you´ll have the same Basic UDI-DI for the 3 contact lenses and One UDI-DI for each hip implants. Each bottle has its own UDI-PI. No, it is visible on the documentation linked to the product (Declaration of conformity, technical files…). EU Directive: • Applicable to all Member States • Sets certain aims, requirements and concrete results that must be achieved in every Member State • Sets a process for it to be … REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. This is a number that identifies a specific product. The UDI requirements are not to be implemented immediately. But do you need to see the UDI appear on the bottle and the secondary packaging. Security of the code start to increase. The European Union issued an update of its MDCG guidance (Medical Device Coordination Group) related to UDI: To review the details of this Guidance you can click on the button below. Deliverables for demonstrating compliance: (1) The Design and Manufacturing processes (Art. This UDI on the product should be available through the UDI-carrier which is the way we are seeing the UDI. The EU MDR date of application is approaching faster than you might think. This is what we saw previously. Among the main changes are: Official date of application of the EU MDR is 26 May 2020. The EU Medical Devices Regulation does not only cover traditional medical devices but extends to aesthetic devices that present certain characteristics and risk profiles as well i.e. The Regulation includes different deadlines for registering in the EUDAMED database, identifying and marking devices etc. So the UDI-carrier is the way you are seeing the UDI code. However, very little of what is required by the new EU MDR … The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. You can have many of them on your portfolio. For example, for class I and IIa single-use devices, packaged and labeled individually. You can identify some numbers in the bracket on the UDI-PI part. Each of these numbers is providing specific information about the product: All these information are dynamic as they change each time you have a new batch or a new expiry date…. Nando (New Approach Notified and Designated Organisations) Information System. If we create for example many versions of product COa: How many UDI-DI do we need? Complex new requirements and new categorization mean that manufacturers should thoroughly analyze the consequences for their current and future product ranges as different classifications come with different requirements. This is a product that combines many regulations. Formatted with the chapters already defined. No changes have … No, it should be visible both in machine readable and human readable part. Need to focus on medical devices or IVDs? This is something we will see in the chapter related to the UDI Carrier. I will teach you how to place a compliant Medical Device on the market. For example, the lot number or the serial number…. Can the UDI be only visible as a barcode? Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI of (EU… The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 … In the full webinar, we highlight the key parts of the MDR, while going a step further to present a step-by-step MDR … Medical device manufacturers have to follow conformity assessment procedures before placing products on the market. It´s different from the UDI-DI. Don´t forget to subscribe to my podcast on your preferred platform. 10, 1), (2) The Risk Management process (Article 10, 2), (3) The Clinical Evaluation process (Article 10, 3), (4) The processes for development and maintenance of technical documentation, UDI and the EU … And under this Basic UDI-DI, you will have one or many UDI-DI (Specific product identification). Learn EU MDR 2017/745 online for free. But let´s speak with an expert in EUDAMED so he can explain to you what it is and how this is working. EMERGO … Just one question for you. You can find this on the MDR … The earlier manufactures prepare for the European Medical Devices Regulation, the more time will remain for testing and trial and error to ensure timely and complete compliance. From Article 120(12), there are already 3 entities that are mentioned (GS1, HIBCC, ICCBBA). There are 3 cases defined on the MDR where you’ll need to change the UDI-DI number. Below are the implementation dates following the class: One last point. Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. The UDI requirement depends on the risk of your product. MDR emphasizes patient safety, stipulating greater transparency, traceability and clinical evidence in support of product safety and efficacy claims. The UDI of the product is composed of the. And those UDI should appear on the primary and secondary packaging. The UDI consists of a UDI-DI (Device Identifier – specific to a manufacturer and device) and a UDI-PI (Production Identifier – identifies the unit of device production). And they should provide an algorithm (to the Commission and the manufacturer) to verify the code. Class I; Class IIa; Class IIb; Class III; This goes from the products with low risk (Class I) to the products with high risk (Class III). Guidance provided to help you identify the content to include. By the dates that you will see in the chapter “UDI transition period” you´ll need to place the UDI carrier on the label of the device and on all higher levels packaging. Human Readable Interpretation (HRI) = is a legible interpretation of the data characters encoded in the UDI carrier. But in case your product is regulated as a Medicinal Product that incorporates a Medical Device, then it’s not mandatory to apply UDI. European Medical Device Directive – Essential Requirements Checklist European Medical Device Directive – Essential requirements checklist Page 1 of 22 EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool. B this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 The quantity of product is 1 unit per secondary packaging. General Safety and Performance Requirements compliant to Annex I. Is the Basic UDI-DI visible on the product? As you understood in the previous chapters, you can need many codes depends on your portfolio. UDI is an information that is required for the EUDAMED. The AIDC should be used for any automatic device that can scan the code. Serialization of medicines in Russia: Deadline is officially extended! Some countries agreed to join the effort to harmonize their regulation so manufacturers can be audited only once for all the countries on this program. Catheters coated with heparin or an antibiotic, Soft tissue fillers incorporating local anaesthetics, Spacer devices for use with metered dose inhalers, Bone void filler with animal growth factors, where the action of the growth factors is demonstrated to be ancillary to that of the physical filler, Non-reusable autoinjectors containing a medicinal product as integral part, Nebulizers precharged with a specific medicinal product, Wound dressings impregnated with an antibiotic, where the primary intended, Bone void filler with animal growth factors, where the action of the growth, The safety or the intended use of the software, Link between Basi UDI-DI and Certificates or Declaration of Conformity. This packaging can contain several of these individual package products. So a new UDI-DI will be required if you change: Ok, let´s pause a moment. Here is the link related to the different fields that should be filled on EUDAMED specifically for UDI data. On Article 120(12) of MDR 2017/745 it says: “Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.”. And there are 2 parts also for it the AIDC and the HRI: Automatic Identification and Data Capture (AIDC) = It is a technology used to automatically capture data. And the HRI should be understandable by humans (It´s in case the automatic device is not working). which is a fixed part that you get by registering with an official entity (GS1, HIBCC, ICCBBA). So what to do with the UDI number for each type of changes. Or, no, you can still use it with the products still valid under MDD. Something that a lot of people were asking is about Basic UDI-DI. Are you a beginner on Medical Device Audits or Regulatory Compliance. Include guidance to prove evidence to the requirements. Basic UDI-DI is an administrative code used only for the company that is manufacturing the product to be identified by the authorities and also to group devices that are part of the same category. It is the dynamic part of the UDI. This can help also to identify which entity did supply you with the UDI number for your Medical Device. Sterile safety lancets would, most likely, be classified according to the rules in Annex VIII of the EU MDR … But we´ll go more deeply on that on the next chapters. The EU is introducing an additional level of transparency in order to detect potentially aggressive tax arrangements. To help medical device manufacturers to comply with the MDR 2017/745 requirements regarding UDI, I created this checklist. [CASE STUDY], Complete Guide: Medical Device Single Audit Program (MDSAP Video), Maximum of 25 characters as this is the maximum length of the UDI-DI. Imagine you are in 2018 and you are manufacturing Product A Version 1. And the UDI-PI (Production Identifier) which is the dynamic part related to the product itself (Lot number, expiry date, serial number…). This should be done by the Commission if you are looking at Article 24(2). To summaries the guidance, I can say that if your product is a Medical Device but incorporate a medicinal product, you have to comply with the UDI requirements. Technological and regulatory developments required important updates though. The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746. Without that, you cannot use it. What are the cases when a UDI-DI needs to change? So the all remain 1 Unit. The UDI number is important because it will be needed for tracking your product. But I hope this chapter will provide you with more relief. The UDI, in general, is provided by an official designated entity. The following 175 pages were published in the Official Journal of the European Union on 5 May 2017. The paper is intended for companies planning to sell or distribute medical devices in the European Union and … My answer to this is no as we are still on the same level. But one last vocabulary that you´ll need to understand is the UDI-carrier. With these conformity assessment procedures manufacturers must prove compliance of the products with the essential requirements laid down in the Medical Device Directive (MDD) respectively Medical Device Regulation (MDR). Every Medical Device manufacturers will need to understand this process as it´s critical for them to be compliant. The UDI human readable format should also include the Application Identifiers. On this database you should register your company, and also your products. The other resource that you can check is the MDCG 2018-1 Draft Guidance on Basic UDI-DI. Maybe the 2 bottles were not manufactured the same day and are packed during another process. … This is the static part of the UDI number. Nowadays, it´s not something new for the Medical Device Industry as it´s also a requirement for products delivered to the US market. You have produced 3 batches with products that have the same UDI-DI but for each batch, it has a different UDI-PI. In the case of Minor changes, like some bug correction, usability enhancements without safety purposes, security patches or operating efficiency; you as a manufacturer should change only the UDI-PI. Richard Houlihan from Eudamed.eu was my guest on episode 25 of my Podcast. On this article I tell you what you need to understand how to implement this new tool. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. Certainly, for the manufacturer who produces medical devices for the EU market today, and who wants to continue supplying those devices beyond May 2021, complying with the new EU MDR will require a lot of additional work. In our case, it should appear to us under 2 format: Automatic Identification and Data Capture, should be used for any automatic device that can scan the code. This is containing all the information that will help you setup your UDI information. Important because it will be required if you are going to claim compliance with the EU-MDR is... Covered by the European Commission issued some guidance for each version of your product is format! Are still on the MDR … this white paper lists all the aspects of the UDI.! Label of the UDI of the UDI, in general, is provided an... The code that is specific to your products manufacturers to comply with same level label of the should. Device that can scan the code why not having a look at article 27 ( 2 ) on database... 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