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Q&A: UDI Registration in EUDAMED

Computer System Validation

The following questions were asked during the UDI Registration in EUDAMED – Why and How to Use It Now webinar presented by atrify’s Lionel Tussau and USDM’s Jay Crowley.

Watch the on-demand webinar: UDI Registration in EUDAMED – Why and How to Use It Now

Does a Medical Device Directive (MDD) legacy device under a brand name that is different from a Medical Device Regulation (MDR) device require its own Single Registration Number (SRN) under that brand?

(Jay Crowley) The single registration number associated to the actor—in this case what I assume is the “legal manufacturer” of the product—if it’s the same organization making the MDD and MDR product, then it’s the same organization SRN. If the product changes during that transition from being a directive product to a regulation product, and part of that change is a brand name, then it would need a new Unique Device Identification Device Identifier (UDI-DI). It would get its own record in the Device Registration and UDI Database module in the European Database on Medical Devices (EUDAMED). It would have two different UDI-DIs: one associated to the legacy device (formally a EUDAMED ID) and one associated to the MDR compliant product (formally a UDI-DI). As long as it’s the same company doing it, it would be under the same SRN.

When do Global Data Synchronization Network (GDSN) data requirements become national requirements linked to the European Union Medical Device Regulation (EU MDR)? For example, in the Netherlands.

(Lionel Tussau) GDSN itself is not directly linked to the MDR and to EUDAMED. In the Netherlands, you have an implant registry, which is created by Dutch law and independent from EUDAMED. But this implants registry must be fed by the GDSN, which is the GS1 Standard to exchange product information.

There is an increasing number of hospitals and group purchasing organizations (GPOs) that are demanding data through the GDSN, which is similar to what you must enter into EUDAMED.

By what channel does the European Commission communicate the updates on EUDAMED?

(Lionel Tussau) You can go to the EUDAMED website every day and check the news yourself, but the most efficient channel is MedTech Europe—the European trade association—which is very engaged with the European Commission (the Commission).

There is no standard channel today that is used by the Commission to proactively communicate what is happening in EUDAMED. Don’t trust the web; you have to go to the right actors, associations, and organizations that work closely with the Commission.

(Jay Crowley) In the U. S. Food and Drug Administration (FDA) there is a mantra, “You either tell everyone or you tell no one.” But the Commission doesn’t work this way. You need to look to the trade associations for feedback on issues and topics. It’s a very different way of approaching regulatory implementation than most of us in the U.S. are used to.

There is a lot of conversation amongst the MedTech members and the Commission, but it’s hard to get insight beyond that. Eventually, the Commission does publish documents to its website. The Medical Device Coordination Group (MDCG) website has a lot of guidance documents.

Regarding EUDAMED and the Commission, unless you have another venue, you’ll have to wait until something is published by the Commission on their website.

How should we address the UDI submission requirements from Finland regarding the EUDAMED modules?

(Lionel Tussau) We are working with the trade associations at the Finnish and European levels to challenge the position of the Finnish competent authority and understand exactly what is required. We are also working with MedTech Europe to get an overview of the strategies and plans of the member states because they have different strategies for national registration obligations during the transition period.

Finland is a hot topic because they say it’s mandatory and it’s a very short period of time. We don’t know to what extent everything is covered. You also have to work from the Finnish documents or unofficial English translations. For the moment, let’s see how the Finnish authorities will answer specific questions presented by the Finnish trade association. Worst case scenario, be ready to register the new devices that you sell in Finland.

You have to distinguish what is voluntary in the European law and what member states are demanding during the transition period. Be ready as early as possible in case there is pressure from some member states.

How do we address a product that is identified as a medical device in one country but not in other countries? When medical devices are globally distributed, it may be confusing to see UDIs on labels when they are not in the country’s database.

(Jay Crowley) This is a complicated issue. As we continue down this path, we will run into issues. In general, if a product is a regulated healthcare product in one country and carries a UDI or a CE mark, that doesn’t necessarily imply anything in another country. If it’s not regulated as a device, then what have you? We see UDIs on products that are not medical devices. You can get into the device/accessory/ component/spare part conversation and there are a lot of products that should be but aren’t, and some products that don’t need to be labeled today with a “UDI.” The U.S. UDI regulation and the International Medical Device Regulator Forum (IMDRF) guidance document states that, just because the product is in the UDI database doesn’t mean it’s a medical device or authorized to sell in that country.

Are there solutions that integrate with Enterprise Resource Planning (ERP) systems like SAP?

(Lionel Tussau) Yes, the atrify solution can be directly connected to ERP systems like SAP.

At what manufacturing volume (i.e., number of devices manufactured per month or year) does it make sense to use XML upload instead of manual entry?

(Lionel Tussau) Using the EUDAMED module manually is challenging because there is little documentation available and no services to guide you in this complex data submission process, and low security in terms of data quality. Machine-to-machine (M2M) is best for data quality (no manual touch point with potential errors); however, a balance must be found based on the number/frequency of devices to be registered and updated.

This is why atrify developed a solution that manufacturers can feed M2M or manually. We also provide services to help you understand the requirements of the EUDAMED registration, check your data (including validation rules based on EUDAMED specifications shared by the EU Commission), and provide you a safe environment to confirm your data are correct before registering them in EUDAMED. This is especially valuable since correcting data is more complex in EUDAMED than in the Global Unique Device Identification Database (GUDID).

Irrespective of the number/frequency of registrations you have to do, you can benefit from atrify’s user-friendly platform and expert services for complying with EUDAMED requirements, and combine your own mode of access to atrify (M2M or manual) with the benefit of the proven interface between the atrify platform and EUDAMED.

You said that there are many documents required to understand EUDAMED, but also that all of the requirements for EUDAMED are not published in order to understand the interactions. Can you expand upon that? (We are a start-up with one device planning to manually register.)

(Lionel Tussau) Understanding EUDAMED means working from the Commission’s EUDAMED UDI Device Data Dictionary and understanding the business rule documents, MDCG guidelines, entity documents, user guides, FAQs, and the MDR or In Vitro Diagnostic Regulation (IVDR).

Some information is not provided at all in official documents (we discovered them by testing thoroughly with EUDAMED), or are in the form of comments provided by the Commission to MedTech Europe documents or as help desk questions.

Even for one device, we recommend doing the registration together with atrify, where our Professional Services team would review with you specific device characteristics and the corresponding data model for a smooth and successful registration.

When registering as an actor (manufacturer), does it matter which generic device group code to use on the mandated European Medical Device Nomenclature (EMDN) or Global Medical Device Nomenclature (GMDN)?

(Lionel Tussau) No, EMDN is only at the UDI level. GMDN is not applicable to EUDAMED.

Does old MDD equipment that has not been placed on the EU market for months or years need to be registered in EUDAMED if some units are still in use in the field (e.g., X-ray systems installed in hospitals)?

(Lionel Tussau) Those devices will not be registered in the UDI module of EUDAMED as long as they are no longer placed in the market, but they could be subject to vigilance reporting.

How long after I produce my medical device do I have to register it in EUDAMED?

(Lionel Tussau) Registration obligations are linked to placing it on the market, not on lead time based on production start. Devices must be registered before being placed on the market. To obtain a Certificate of Free Sale, you must register the device in EUDAMED even if it is not placed on the EU market. Note that the EUDAMED market is bigger than the pure European Union territory. Some countries like Norway or parts of countries like Northern Ireland are covered by EUDAMED registration obligations.

Is UDI needed for medical device accessories, too?

(Jay Crowley) Yes, accessories to medical devices are considered devices for the purposes of the MDR and UDI:

Article 1.4 For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices.’

Do we need to use EUDAMED for a Certificate of Free Sale?

(Lionel Tussau) Absolutely; devices must be registered in EUDAMED to get a Certificate of Free Sale.

Additional Med Dev Resources

Solutions for Medical Device Manufacturers
Reimagining Medical Device Post-Market Surveillance
An Open Letter to Medical Device Regulators
EU MDR Date of Application Readiness Guide


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