What does MDR stand for in medicine

What does Unique Device Identification mean for medical technology?

Soon things will get serious with the UDI: From May 26, 2020 - according to the Medical Device Regulation) all medical devices with their master data and the unique product identification (UDI) should be stored in an EU-wide database (Eudamed) - comparable to the American UDI labeling for the FDA. From 2021, the first medical devices will have to be labeled themselves. Read here what is required - even if the introduction of Eudamed is postponed for the time being.

Anke Biester
Specialist journalist in Aichstetten

The idea is generally praiseworthy, because it is about patient safety and the traceability of medical products - worldwide: in the future, every medical product should be clearly labeled and thus identifiable. In addition, it receives a product identification, in English "Unique Device Identification", or "UDI" for short. This UDI should be readable by human eyes in the form of a numerical code and in the form of a bar or 2D code, for example, by machines. It was discussed on behalf of the US Food and Drug Administration (FDA) and decided at an international level. At the European level, the associated regulation is "Medical Device Regulation (MDR)". It was introduced in 2017.

Table of Contents

1. UDI and MDR: The end of the transition period is approaching
2. Postponement for Eudamed
3. Recertification of medical devices according to MDR
4. Notified bodies are the crux of the matter
5. MDD certificates as a way out
6. MDR and UDI: waiting is not the solution
7. UDI-compliant, MDR-compliant: No small thing
8. Effort is hardly manageable for SMEs
9. Basic knowledge of Unique Device Identification (UDI)
10. Special role Basic UDI-DI
11. Where does the UDI have to appear?
12. From when on UDI?

UDI and MDR: The end of the transition period is approaching

The fact that the discussions about the MDR and in connection with the UDI are only really boiling up is due to the granted transition period, which will soon expire - and some uncertainties. Nonetheless, it will apply from May 26, 2020, and medical device manufacturers who want to sell their products within the EU must assign them a unique UDI. With the associated master data and a clear so-called basic UDI, this should be reported to the EU's UDI database, which will be part of the Eudamed EU database, within a transitional period of (currently) 18 months.

Postponement for Eudamed

The date for the new Eudamed database has been postponed

The FDA has already shown how this can look in principle: It has already made the UDI mandatory. The data is collected here in the US “Global Unique Device Identification Database” (GUDID). One might think that those who have completed the procedure for the American market are also quite well equipped for the upcoming UDI introduction at EU level.

Recertification of medical devices according to MDR

Actually, the whole thing unfortunately has a catch: The “FDA-UDI” cannot be transferred 1: 1 to the “EU-UDI”. There is no globally standardized numbering system. That would be too nice and easy. And speaking of simple: The requirements for the “FDA-UDI” are far simpler, because the FDA's UDI database is not directly linked to the approval procedure.

The EU, on the other hand, tried the really big hit with the MDR. Here the certification database is related to the UDI database. This means that the whole process of the new certification of medical devices required by the MDR is closely linked to the UDI.

And here lies the real problem: So far, as of mid-October 2019, there are only five notified bodies for this new certification - compared to 58 according to the old Medical Device Directive (MDD): in Germany these are Dekra, TÜV Rheinland and TÜV Süd.

Notified bodies are the crux of the matter

Further positions are to follow, but are still in the naming process. It may still take some time before they are fully operational, because: "The MDR control system is still in constant change," says Dr. Bassil Akra, Head of Strategic Business Development in the Medical Device Division, TÜV Süd, from personal experience. “We were one of the first two notified bodies for the MDR and have only issued two certificates because there are always new interpretations at EU level. We are in a kind of 'calibration phase' that will probably drag on until the end of 2019. "

And this despite the fact that the proportion of products to be certified by the Notified Bodies has increased as a result of the new MDR. A declaration of conformity completed by the manufacturer alone is no longer sufficient, for example, for reusable surgical instruments and medical software.

MDD certificates as a way out

In order to get more time, many companies are currently renewing the certificates for their products in accordance with the Medical Device Directive (MDD), which is still in force, because these will still apply beyond May 26, 2020. But there is a catch: According to the MDR, these products must also meet the requirements of the MDR from May 2020 - for example, post-market surveillance and market surveillance.

The uncertainty among manufacturers is therefore great. Meinrad Kempf, project manager at MedicalMountains GmbH in Tuttlingen, reports: “Many companies would have liked to start recertifying a product as a 'test balloon' in order to find out what might still be missing. But the notified bodies are not ready yet. Therefore the first attempt has to be right now. "

Prepare the data quickly despite the Eudamed postponement

MDR and UDI: waiting is not the solution

But waiting is not a solution either, warns Dr. Bassil Akra from TÜV Süd: “The companies have to clarify two things with the designated body they have chosen. Firstly, when and whether this will be named for the new MDR, and secondly, whether it will then still be able to certify all of the manufacturer's products according to the MDR - a lot will change. It is expected that there will only be a few notified bodies that can certify Class III products. We are one of them. "

Another sticking point that is not yet clear to many companies: “For certification, all requirements must be met, nothing can be submitted later. It therefore makes sense to discuss a timeline with your notified body, when will the data be 'UDI-compliant', when quality management and so on. "

UDI: labeling

UDI-compliant, MDR-compliant: no small matter

Making a product “MDR-compliant” is anything but trivial, says Corinna Mutter from Spectaris: “UDI and Eudamed represent a complete small IT project for every company. Data and system maintenance must be continued continuously. This means a high level of capacity commitment and is probably not possible without additional personnel and professional help in the IT area from outside. "

Investments that are difficult or even impossible for many small and medium-sized enterprises (SMEs) to manage. In addition, they have to keep their data up-to-date and consistent across all systems and, as part of post-market surveillance, also collect, document and evaluate clinical data after the market launch. Very few manufacturers simply shake such additional effort off their sleeves.

Effort can hardly be met for SMEs

The result: According to a study by Spectaris and the German Chamber of Commerce and Industry, around half of the 282 companies surveyed want to reduce their product lines. Around a third of the companies that have to classify their products higher according to the MDR are already planning to take products out of the program. Meinrad Kempf from Medical Mountains confirms this: “In terms of personnel alone, it is difficult for SMEs to cope with the additional administrative effort. We encounter three reactions: Manufacturers withdraw from the market and become 'extended workbenches', companies are sold or closed completely. A fatal development, since it is the SMEs in particular that enrich the market with new ideas. "

The region around Tuttlingen is particularly affected, as many manufacturers of products are based here that fall into the newly created class Ir: reusable surgical instruments. You now have to be certified by a notified body - of which, as I said, there were only five in October 2019.

Medical Mountains therefore offers workshops and seminars on MDR as well as certificate courses to support companies and build up know-how in their own operations. The state of Baden-Württemberg is also the first federal state to provide funds for an MDR emergency aid program specifically for its medium-sized medical technology sector.

Basic knowledge of Unique Device Identification (UDI)

  • Who awards the UDI
    The unique product identification, in English "Unique Device Identification" (UDI), is assigned by various bodies. Currently these are GS1, HIBCC and ICCBBA. The Health Industry Barcode HIBC and the GS1 code are equally suitable as UDI codes for medical devices. The ICCBBA UDI code is recognized by the FDA - and thus probably also by the EU - for labeling products of human origin (such as blood plasma or transplants).
  • What the UDI is made of
    The UDI consists of two parts, the product identifier (UDI-DI) and the production identifier (UDI-PI):
    - The UDI-DI = UDI Device Identifier is used to identify the product and manufacturer and must be applied to the product itself and its packaging. It contains information such as the trade name, information about reusability, sterility and so on - a total of around 20 dates. Depending on the allocation office, it contains the GTIN (Global Trade Item Number) (GS1), the UPN (Universal Product Number) (HIBCC) or the ISBT 128-PPIC (Processor Product Identification Code) (ICCBBA).
    - the UDI-PI = UDI Production Identifier marks the batch of a product and thus among other things: lot or batch numbers, serial numbers, expiry and / or manufacturing dates.

Special role Basic UDI-DI

The Basic UDI-DI takes on a special role. It is a type of model identification and includes products of the same type with the same purpose and risk class, for example with different engine strengths. It serves as a key for the UDI database, but does not appear on the product or its packaging. And it is also this that is to be specified by the manufacturers (probably from May 26, 2020) with further data elements in the UDI database. The manufacturers are also obliged to maintain a list of all assigned UDIs as part of the technical documentation for each medical device.

Where does the UDI have to appear?

From 2021, the first medical device manufacturers will have to label not only the product itself, but also all higher-level packaging (with the exception of the container) with the UDI. Especially important for reusable products: The code must remain legible over the entire service life - this is particularly important for reusable surgical instruments that have to withstand many cleaning cycles, for example.

Laser marking with subsequent passivation scores here - according to a study carried out in 2017 by Foba Laser Marking + Engraving, Selmsdorf and Add'n Solutions GmbH & Co. KG, Tuttlingen: the UDI marking applied and protected in this way remained on the stainless steel for at least more than 500 sterilization and cleaning cycles clearly legible.

Some manufacturers, such as Trumpf from Ditzingen, offer complete packages including software. The correct UDI marking is created from the manufacturer's database, sent to the laser marker and the product is provided with UDI - with subsequent quality control and documentation if required.

Baden-Württemberg starts first MDR emergency aid program

When is the UDI?

The labeling requirement must be introduced at different speeds, depending on the product class:

  • for class III and implants: from May 2021
  • for class IIa and IIb: from May 2023
  • for class I: from May 2025

Useful information on UDI and MDR

FAQ about the UDI:
https://ec.europa.eu/docsroom/documents/36664

List of notified bodies according to MDR in Germany:
www.zlg.de/medizinprodukte/dokumente/stellenlaboratorien/benanned-stellen-eu-2017745-mdr/

Lists of notified bodies according to MDR in the EU:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
www.johner-institut.de/blog/regulatory-affairs/unique-device-identification-udi/
www.imdrf.org/documents/documents.asp

EU guide to UDI:
https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en
https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

NAKI - National Working Group for the Implementation of the New EU Regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR)
https://www.bundesgesundheitsministerium.de/naki/?L=0
www.gesundheitsindustrie-bw.de/MDR-IVDR

Information on UDI provided by the laser marking specialist Foba
https://www.fobalaser.com/blog/de/faq-zu-udi-teil-2-wie-haben-udi-codes-sicherheit-gekhaben/


More on the subject of UDI: labeling