FAQ

As central service provider in the German pharmaceutical market and neutral clearing agency, IFA GmbH supports suppliers of medicinal products, medical devices and other pharmacy-typical products in complying with legal specifications. This includes complying with national and European specifications especially those according to § 131 paragraph 4 SGB V.

Against this background, the given information to IFA is the prerequisite for especially doctors, pharmacies, pharmaceutical wholesalers and health insurers to handle, use and bill the product correctly.

Thus each supplier aids a safe patient care and correct billing.

The regular deadline applies to the publication of medicinal products obliged to marketing authorisation or mandatory registration into IFA's Database. IFA's Publication Calendar states all deadlines for their equivalent publication date.

In individual cases, the necessary marketing authorisation or registration of medicinal products may be handed in by the deadline for product changes.

If the documents are not handed in in time, the publication of the medicinal product into IFA's Database is impossible.

No, the information maintained in the IFA database is economic, legal and logistical data on pharmaceuticals, medical devices and other pharmacy-typical goods. They do not contain image data.

IFA's supplier contract may be terminated by either side with a time limit of three months to the end of each calendar year in written form to the other partner: form for termination of the IFA supplier contract

The desired change affects one of the so-called artikelidentifizierendes Merkmal (product identifying characteric): Produktbezeichnung, Darreichungsform, Packungsgröße, Artikeltyp and the attribute Arzneimittel.

For the PZN to remain uniquely identifiable for the market participants at any time, product identifying characteristics must not be changed for published PZNs (cf Richtlinien für die Zuteilung von Pharmazentralnummern). In this case, a new PZN must be published.

Ärztemuster according to article 96 of the regulation 2001/83/EG must bear the security features according delegated act (EU) 2016/161 (article 2 and 41).

A frequent question is how the samples need to be treated. The pharmaceutical entrepreneur creates a serial number during the packaging process and uploads it into the European HUB. Before the pack is dispensed to a doctor, the pharmaceutical entrepreneur deactivates the serial number. Thus making sure that the pack may not be dispensed elsewehere. The PZN can remain the same for packs being used as physician samples during the production process. For packs that are used as physician samples exclusively, a PZN must be allocated.

No, Ärztemuster cannot be ordered by pharmacies or pharmaceutical wholesalers.

In general, notifying physician samples is not treated differently to medicinal products of the product type standard. The following product information/proofs have to be submitted:

• Summary of product characteristics (SmPC)
• Proof of MA – proof of registration (excerpt from AMIce database preferred)
  

   

The following notification channels are available:

• IFA portal
• IFA-Auftragstabelle B1 – First Publication Medicinal Product
  

The following entries differ from a medicinal product with the product type standard:

• Artikeltyp: Ärztemuster gemäß AMG
• Preisinformationen: no entries; without VAT
• Packungsgrößenverordnung (PackungsV): nicht betroffen
• all Vertriebswege: nein

Clinic packs are dispensed to hospital pharmacies or pharmacies supplying to hospitals exclusively. Thus notifying the KHAEP for medicinal products with the product type Klinikpackung suffices.

For clinic packs with a reimbursement Erstattungsbetrag nach § 130b SGB V notifying the APU § 78 (3a) 1 AMG is mandatory. Additionally, prices for APU and PPU may be notified. AEP, AVP, AEP PPU and AVP PPU remain without entry.

Medicinal products that are not apothekenpflichtig and other pharmacy-typical products are not subject to price regulations. For those, the prices KHAEP, APU, AEP and / or UVP may be calculated freely and notified as to the liking of the supplier. Notifiying the AVP is not allowed due to the fact that it is linked to the AMPreisV or a different price regulation.

Generally, only authorised (zugelassen or registriert) medicinal products may be marketed. Since the MA documents constitute proof of legitimate authorization or registration, they constitute the prerequisite for the marketing of a medicinal product. Thus the MA documents must be submitted with each first publication into IFA's Database of medicinal products obliged to authoristaion or registration.

The product information is used i. a. to:

The specifications in the software of for example pharmacies or pharmaceutical wholesalers shall match as closely as possible the ones on the pack. This aids linking the product itself to its entry in the software and especially concerns specifications such as Produktnamen, Darreichungsform and Menge und Einheit (Packungsgröße).

The product information is also used to correctly classify the product for example Medical Device, Food Supplement, Biocidal Product etc.

For data changes regarding the legal classification or the attribute apothekenpflichtig, the product information must be added to the order for further inspection.

According to DIN 58953-8:2010-05, sterile medical devices should be delivered, transported and stored in a so-called packaging system, consisting of a primary (sterile barrier system) and an additional (non-sterile) outer secondary packaging (protective packaging).

This means that there are only two possibilities for the assignment of the PZN as follows:

1. PZN assignment for a single sterile medical device that is properly packed in a sterile barrier system and protective outer packaging.
2. PZN assignment for a protective package. The protection packing (e.g. the pack size 10 pieces) contains several sterile medical devices without individual protective packaging. The PZN should only be applied to the protective packaging, as the individually packaged sterile medical devices have no specific protective packaging.

Consequently, the PZN may not be used for sterile medical devices in a sterile barrier system without protective packaging.

Stating the producer's address for Nahrungsergänzungsmittel is used for a transparent country of origin.

Please notify your product’s Battery registration number by stiftung ear for publication in the IFA database if the following applies:

• You are supplier of a product with a registration obligation according to Batteriegesetz (BattG).
• You received an 8-digit Melderegister number upon registration obligation from stiftung-elektro-altgeräte register (stiftung ear).
• The product was marketed for the first time in Germany by you or a different supplier.

Batteries and accumulators are obliged under Batteriegesetzes (BattG) and not under Elektro- und Elektronikgerätegesetz (ElektroG).

Yes, please notify stiftung ear’s number (WEEE-Reg.-Nr. DE) in the following cases, so that it can be published in  IFA's Database:

• You are supplier of a product whose producer underlies the mandatory registration by stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG).
• The product received an 8-digit WEEE-Reg.-Nr. DE by stiftung ear (www.stiftung-ear.de).
• You or another supplier (both underlying the mandatory registration) launch the product in Germany for the first time.

Yes, all products listed with “ja” in the following attributes should be registered with a Registrierungsnummer:

• ElektroStoffV: yes underlies regulation Elektro- und Elektronikgeräte-Stoff-Verordnung
• stiftung ear: yes, the manufacturer of the product underlies the obligatory registration with stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG)

Participants of the pharmaceutical market can gather information from the attribute WEEE-Reg.-Nr. DE (Registry number of stiftung ear according to ElektroG) such as the number itself under which the producer of electronics, for which the PZN has been assigned to, is registered in Germany. And thus the return of the device is regulated.

Verbandmittel gemäß § 31 Abs. 1a SGB V may be prescribed or billed to the health insurer. Thus the correct notification is important to the supplier's interests.

§ 31 paragraph 1a SGB V defines a Verbandmittel. Further information on Verbandmittel and their circumscription to other wound care products is regulated through the Gemeinsame Bundesausschuss.

These attributes are used by pharmaceutical wholesalers, pharmacies and doctors to i. a. handle the products legally conform and to use them correctly – in general but also unexpected cases such as for example an accident.

Relevant people are obliged to obey hazardous substances legislation and technical regulations and to fulfil their vigilance obligation for hazardous substances. Upon receipt of the products, certain information must be available and recognisable in the data.

The UN-Nummer is stated on the Sicherheitsdatenblätter (safety data sheet) for products with hazardous substances.

Yes, if the product is a hazardous substance.

The attribute solitäres Fertigarzneimittel (solitary proprietary medicinal product) is used to notify packs of medicinal products that are excempt from the manufacturer's discount according to § 130a paragraph 3b SGB V (so-called "Generikaabschlag"). Further information can be found in the Leitfaden Herstellerabschläge (Rahmenverträge zur Arzneimittelversorgung > Für pharmazeutische Unternehmer).

A "Generikaabschlag" (generics discount) is the manufacturer's discount according to § 130a paragraph 3b SGB V. Further information can be found in the Leitfaden Herstellerabschläge (Rahmenverträge zur Arzneimittelversorgung > Für pharmazeutische Unternehmer). To identify packs of medicinal products affected by the "Generikaabschlag", information from the notified attributes Wirkstoffpatent, Unterlagenschutz, biologisches Arzneimittel and solitäres Fertigarzneimittel.

You can notify this by entering the applicable value in the datafield Ablösung Abschlag § 130a SGB V – Overruled discount Section 130a SGB V. The notification of this change can be done in the IFA portal or in an EAD file EAD total. 

If value 1 is notified, the Datum, ab dem die Ablösung des Abschlags § 130a SGB V gilt must also be stated.

The manufacturer discount according to § 130a SGB V is calculated by ABDATA Pharma-Daten-Service with exception to the discount of vaccines. If and to what amount the generic discount applies, depends on the provided information (see IFA-Auftragstabelle B1 – First Publication Medicinal Product > Rechtsinformationen). Thus when in doubt about calculating the manufacturer's discount, these attributes should be checked first. For further questions on the calculation please contact your manufacturing association directly.

Please note that marking your medicinal product as generic according to § 10 (1) of Directive 2001/83/EC (German: Bezugnehmende Zulassung Generikum) does not result in a generic discount for the product.

The manufacturer discounts are regulated in § 130a SGB V for medicinal products billed to the GKV, and in § 1 AMRabattG for medicinal products billed to the PKV or civil services. You can find an overview to facilitate reading the paragraphes of § 130a SGB V:

Paragraph 1 manufacturer discount

• 7% discount for medicinal products
• 6% for generics and off-patent medicinal products
• 7% for OTC
• 7% for finished medicinal products in parenteral preparations
• 7% for outpatient treatment in hospitals

Paragraph 2 discount for vaccines

Paragraph 3 no manufacturer / vaccine discount for reference-priced medicinal products

Paragraph 3a price freeze

• No price freeze for reference-priced medicinal products
• Discount resulting from the price freeze will be charged in addition to the manufacturer discount and generic discount

Paragraph 3b generic discount

• 10% discount for generic and off-patent medicinal products
• Price cuts reduce the generic discount
• Generic discount does not apply to medicinal products 30% below reference price

(in addition to this please see faq What is a "Generikaabschlag"?)
...

Paragraph 8 discount contracts

• Manufacturer / vaccine discount can be credited on discount contracts
• Manufacturer / vaccine discount can also be credited on arrangements for a refund according to § 130 b paragraph 1 sentence 4 SGB V

The following abbreviations are used in the IFA documentation with the channels of distribution information: 

• KVA / Krankenh.Apo. // VWeg KVA – distribution to hospital pharmacies
• pharm. Großhandel // VWeg GH – distribution to pharmaceutical wholesale trade
• Apotheken // VWeg APO – distribution to pharmacies
• Einzelhandel // VWeg sonst. EH – distribution to other retail trade

A product is labelled as Außer Vertrieb – Marketing ceased (AV), the product is removed from the market and will not be re-supplied. However, stock may be sold-off. These products retain this distribution status until they are deleted and cannot be reactivated (see Richtlinien zu Artikelstatus und Statuswechsel and Change of product data).

Products with a temporary delivery discontinuation or inability to deliver should remain on the market unless the production has ceased.

Agreements between manufacturer and supplier can be very complex. It is impossible for the IFA GmbH to judge who possesses the rights in each and every case. Thus we only allow order forms from the currently listed supplier. In the case of a change in the distribution law, this must be made known to the IFA GmbH immediately from both sides ( PZN transfer to another supplier). If there are disagreements between the manufacturer and distributor, it is up to both to resolve them and inform the IFA GmbH accordingly. In both cases, the IFA GmbH requires consensual letters to take change orders in the future.

A PZN transfer to another supplier will only be processed, if both an order from the new supplier and the previous supplier's consent to the PZN transfer have been received. Both, already published as well as pre-allocated PZN can be switched. If individual PZNs are to be transferred, they must be named explicitly (see Change of product data).

A manufacturing authorization (Herstellungserlaubnis) according to § 13 of German Medicinal Products Act (Arzneimittelgesetz – AMG) is required by all entrepreneurs, that manufacture medicinal products commercially or professionally within the meaning of § 2 AMG. Manufacturing here includes the production, extraction, preparation and offering of medicinal products. This requirement applies to any company that is involved in any step of the production of medicinal products. This applies regardless of whether the company also acts as a pharmaceutical entrepreneur pursuant to § 4 (18) AMG - or as holder of the authorization or markets medicinal products under his name. Contract manufacturers which perform certain manufacturing steps on behalf of the pharmaceutical company, are also required to have a manufacturing authorization. A manufacturing license is required for the production of medicinal products which are not yet approved - e.g. for medicinal products that are used in a clinical trial (so-called investigational medicinal products) or other medicinal products which do not require approval. If you hold a Herstellungserlaubnis according to § 13 AMG, please send a copy thereof to us. For more information see: § 13 AMG.

A wholesale license according to § 52a AMG is required by all companies which trade in medicinal products either professionally or commercially. According to § 4 (22) AMG, trading involves the procurement, storage and sale or export of medicinal products. The transfer of medicinal products to clinicians, veterinarians or hospitals is exempted from this rule. Exceptions to this permit requirement are in the travel industry, gases for medicinal purposes, in the normal course of operation of pharmacies as well as in the context of purchasing groups. If you hold a Großhandelserlaubnis according to § 52a AMG, please send a copy thereof to us. For more information see: § 52a AMG.

No, the distributor cannot be named. The phone number, fax number and email address of the distributor can be stored.

Following the Framework Agreement according to Section 131 SGB V (German Social Code Book V), this information is compulsory for medicianal products for human use.

The allocation of the product-specific address data to the PZN is usually conducted when ordering the first publication in the IFA information services of new prescription drugs and non-prescription drugs relevant for reimbursement. 

Please use the IFA portal (only available in German) or the following notification order document and enter the address data for each PZN (address number or company name of the authorisation holder / local representative):  

• IFA portal
• IFA-Auftragstabelle B1 – First Publication Medicinal Product

There are two options for the notification of product-specific address data:

• Complete the address data (address number or company name of the marketing authorisation holder / local representative) for the respective PZN in the IFA-Portal.
• Please order a product range data file and fill in the address data (address number or company name of the marketing authorisation holder / local representative) and send it conclusively by e-mail to ifa@ifaffm.de.   

No, for the notification of product-specific address data EAD files cannot be used.

The IFA information services include economic, legal and logistical data on medicinal products, medical devices and other pharmacy products. It does not include pharmaceutical information such as active ingredients, indications or ATC codes.

The data is output in ASCII format. Given that it is raw data, it first requires programming of the data.

As a neutral and central service provider for standardised and quality-assured information in the health sector, IFA GmbH is committed to harmonising data and provides raw data.

These offer data recipients the possibility to adapt the data to their specific needs and requirements and to implement it, for example, in enterprise resource planning systems.

No, due to the fact that the PZN (including check digit) is an 8-digit number.

A PZN as barcode in Code 39 bears a PZN in clear print underneath the barcode: PZN - 12345678. The minus sign in front of the PZN is used as identifier and causes the reader to interpret the digits as PZN.

Receiving PZN and their publication requires the signing of IFA's supplier contract outlining the buisiness relations.

A PZN is issued while product data are being published in IFA's database. At the bottom of all this are IFA's guidelines that are aimed at the primary purpose - identifying products within the healthcare sector. IFA's guidelines IFA-Richtlinien für die Zuteilung von Pharmazentralnummern  line out the conditions for the publication of product data in IFA's database.

No, due to the fact that the PZN is a neutral identification key. It is generated automatically.

Notifying a product deletion leads to the product and its data being deleted from IFA's database and the systems of data recipients. A new publication of a deleted PZN is impossible.

Information on implementing the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation (EU) 2016/161 (DR) in the IFA database can be found in Guidelines for Notifying Product and Address Data.

Further information can be found here:

https://www.bfarm.de/EN/Medicinal-products/Information-on-medicinal-products/Falsified-medicines-directive/_node.html

Obliged to verification are all prescription-only medicinal products for human use that are not mentioned as an exception in the White List (i. a. some homoepathics). Furthermore, OTC medicinal products mentioned in the Black List are obliged to verification (currently medicinal products with the active agent omeprazole in two potencies). White and Black List can be found in the appendix of the Delegated Regulation (EU) 2016/161.

Yes, clinic packs of medicinal products obliged to verification must be verified.

No, clinic components (smallest unit of a clinic pack) may not be verified. However, the clinic pack to which the clinic component belongs must be verified if the medicinal product in question is obliged to verification.

Yes, physician samples according to AMG are, if the medicinal product itself is obliged to verification, also obliged to verification according to Article 41 DR. Prior to dispense, the physician sample obliged to verification must be checked out by the pharmaceutical entrepreneur. In contrast OTC, non-prescription-only, physician samples do not have to be verified unless they are stated in the Black List.

There are three variants of physician samples for pharmaceutical entrepreneurs:
a) smallest sales pack with additional marking as physician sample (physician sample bears PZN of sales pack)

b) physician sample in unique pack (physician sample bears own PZN); package size equals the smallest sales pack

c) physician sample in unique pack (physician sample bears own PZN); package size smaller than smallest sales pack

For variants b) and c), product types physician sample will be published in the IFA Database with their own PZNs.

Affixing a PZN in clear print or Code 39 to medicinal products dispensed as physician samples (product type Ärztemuster gemäß AMG in the IFA database) is legally not obliged. However, physician samples obliged to verification must be affixed with the DMC including the 4 data elements (product code, serial number, expiry date, batch number) and their clear print information. Generally it is recommended to print the PZN in clear print since this eases usage and documentation in medication plan.

The pack's security features of medicinal products obliged to verification are:
a) anti-tampering device
b) unique identifier, consisting of four data elements in the Data Matrix Code.

The unique identifier consists of:

a) product number
b) individual serial number
c) batch number
d) expiry date

The anti-tampering decive, preventing interferance with the product, makes the first opening of the pack evident. Further information on the different options can be found on the website of the Deutsches Institut für Normung and the Europäisches Komitee für Normung (DIN EN 16679:2015-03).

ACS PharmaProtect GmbH is the system operator responsible for the contractual and technical connection of the relevant pharmaceutical entrepreneurs on the German market. In order to connect to their system, pharmaceutical entrepreneurs have to contact ACS PharmaProtect GmbH directly.

European Medicines Verification Organisation - emvo's task within the scope of implementing the FMD is coordinating the verification on a European level. It hosts the European hub organising verification queries from European countries. Pharmaceutical entrepreneurs affected by the FMD and registered with ACS PharmaProtect GmbH must also register with EMVO.

Yes, the Delegated Regulation (EU) 2016/161 requires randomising serial numbers. Pharmaceutical entrepreneurs are responsible for its technical realisation. securPharm coding regulations must be followed.

Yes, the Delegated Regulation (EU) 2016/161 requires the serial number in clear print. An exception can be made for small packs (sum of two smallest sides < 10 cm).

Yes, the PPN (or NTIN) emblem must be affixed next to the Data Matrix Code in clear print. If the pack bears different codes, using the PPN indicates the relevant code for verification. Exceptions from affixing the emblem may be found in securPharm's coding regulations for pharmaceutical companies.

Yes, a pack may bear more than one Data Matrix Code. The relevant Data Matrix Code to the pharmacy system is marked with the emblem PPN. Scanning other codes will be recognised and ignored by the system.

Pharmaceutical entrepreneurs are obliged to affix PZN in clear print and Code 39 or as Data Matrix Code (DMC) on the outer pack according to the amended frame agreement § 131 SGB V. 

Positioning is neither regulated in the FMD 2011/62/EU nor the Delegated Regulation (EU) 2016/161. The pharmaceutical entrepreneur determins the positioning due to the pack's layout and printing cirmumstances.

Generally the PZN may be affixed anywhere on the pack. For centrally authorised medicinal products, the PZN must be placed in the blue box.

Single Market Packs (SMP) without Blue Box:
According to DR, the product code must be affixed close to the Data Matrix Codes. Germany permits PPN or NTIN as product codes. Both contain the embedded PZN. Printing the PZN as fifth element of the Data Matrix Code and in clear print with the label "NN: " is not necessary. According to the frame agreement according to § 131 SGB V, the PZN has to be included in the DMC and affixed in clear print with the label "PZN: " on the outer pack since 09.02.2019.

Packs with Blue Box:
The DR does not state specific indications. Since the unique identifier (UI) cannot be linked to a country, the UI cannot be part of the blue box (neither Data Matrix Code nor clear print). The frame agreement according to § 131 SGB V calls for PZN identification in accordance with the "BLUE BOX" requirements within the box "Deutschland". PZN is to be affixed without "NN: " since it it not part of the UI (CMDh/201 - OUTER PACKAGING - #18 refers to the UI).

Multi Market Packs (MMP) with Blue Box:
The pharmaceutical entrepreneur determins which internationally unique product code to use to verify the pack. The product code and serial number are outside the blue box. For identifying further markets and reimbursement purposes, a nationally used product number is used. It may be affixed onto the pack or linked via the database. If it is stated on the pack, "BLUE BOX" requirements apply.

For packs not obliged to the falsified medicines directive (FMD), the Data Matrix Code may be used optionally according to the coding regulations. The DMC has to contain at least the product code in the form of PPN or NTIN. Additionally, the batch number and expiry date may be included. FMD does not allow to affix a serial number.

The verification information Verifizierungspflicht gemäß Fälschungsschutzrichtlinie – Verification mandatory according to Falsified Medicines Directive and Verifiz Pflicht ab Verfall – Verification mandatory from expiry date onward in the IFA database is used to identify medicinal products obliged to verification.

For first publication of new medicinal products obliged to verification, a corresponding entry must be notified in the data field Verifizierungspflicht gemäß Fälschungsschutzrichtlinie – Verification mandatory according to Falsified Medicines Directive.

In the rare cases when medicinal products first become obliged to verification as a result of a change in legal requirements, in addition to marking the Verification mandatory according to Falsified Medicines Directive data field, the expiry date of the first batch subject to mandatory verification must be notified in the data field Verifiz Pflicht ab Verfall – Verification mandatory from expiry date onward. 

Generally, IFA GmbH transfers datas of PZN obliged to FMD when first publication happens at the time of their launch to ACS PharmaProtect GmbH. If the notification is done without a blocking period, data will be transferred 10 working days prior to the publication data (with blocking period: 5 working days). Only after a PZN has been announced in the ACS system it is possible to upload serial numbers.

If a longer timeframe is requested for uploading the serial numbers, an unpublished PZN (PZN pre-allocation) may be applied for in advance, and IFA GmbH may be instructed to forward this to ACS. Such a PZN pre-allocation is announced to ACS PharmaProtect GmbH 10 working days before the next publication date. Irrespective of this, requests for the first publication of the PZN in the IFA information services must be submitted as before.

UDI (Unique Device Identification) is a system to uniquely identify medical devices worldwide according to Article 27 of the MDR (Regulation (EU) 2017/745 dated 05.04.2017). UDI is the broader term for a unique product identification consisting of the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI). These items are described in Annex VI, part C of the MDR.

The basic UDI (BUDI) is the main key for grouping those products of a manufacturer that have the same properties. According to the guideline “MDCG 2018-1 Guidance on BASIC UDI-DI and changes to UDI-DI”, these properties include the intended purpose, risk class, essential design and manufacturing characteristics. With the help of the basic UDI and EUDAMED, the joint reference to the products with regard to the documentation, specifically to the certificates, is to be created.

In principle, the basic UDI is composed of the following four elements (substring elements):

• Issuing Agency Code (IAC)
• Manufacturer Code
• Device Group Code
• Check Digit

The basic UDI is generated by the manufacturer itself. For this purpose, the manufacturer forms product groups according to the above mentioned MDCG 2018-1 Guidance and denotes the Device Group Code for them. The method and further elements are described in the Specification Unique Device Identification (UDI). IFA GmbH provides the manufacturer with a BUDI Generator to calculate the check digit.
 
The basic UDI is not applied to the package and is not stored in the IFA database.

The UDI-DI (UDI Device Identifier) is a unique product identifier, which is assigned to the product itself or its packaging. For the use of the IFA Coding System, the PPN is used as the UDI-DI. The PPN represents the PZN in an internationally unambiguous format. When issuing a PZN, IFA also issues the PPN at the same time.

Depending on the requirement for a medical device, the manufacturer determines the UDI-PI for his product and labels the packages accordingly. The UDI-PI can be the batch number, expiry date and, in certain cases, also the production date or a serial number assigned by the manufacturer. This applies also for reusable medical devices that are to be refurbished. For these common data elements, the internationally standardised data identifiers in accordance with the international standard ANSI MH 10.8.2 can be used. The IFA Coding System references this standard.

The EU Commission shall set up a central database (EUDAMED) for medical devices according to Article 28 MDR.

A published or pre-allocated PZN can be used uniquely identifying worldwide in the form of the PPN as UDI-DI. This way, the PZN is eligible for registration in EUDAMED.

In accordance with the requirements regarding certain medical devices the manufacturer defines the characteristic(s) suitable for product traceability.

The EU Commission informs on its website that the various modules for voluntary use will be made available step by step. Current information can be found here: https://ec.europa.eu/health/md_eudamed/overview_en. Date of application of the MDR remains 26.05.2021.

IFA GmbH has implemented a data field in which to report an UDI-DI. The UDI-DI of a different issuing entity can also be entered there.

No, because IFA guidelines already concur with the MDR. Please note that Appendix VI of the MDR calls for special issuing rules for UDI-DIs.

Yes, because your product data will not be forwarded to EUDAMED by IFA GmbH.

The UDI-DI (PPN) and the manufacturer's determined UDI-PI have to be included in compliance with IFA's Coding System in the Data Matrix Code. Any other data elements may be, but are not obliged to be, included in the Data Matrix Code.

No, the Basic-UDI does not appear in plain text or in the code. It is used in EUDAMED, certificates and documentation as a key for grouping products.

The manufacturer has to contact one of the issuing entities named by the European Commission. IFA GmbH is one of these issuing entities.

The manufacturer assigns the UDI-PI in accordance with the requirements of the MDR regarding traceability (cf. IFA Specification UDI).

Annex I, Chapter III No. 23.2. point i) MDR requires an unambiguous indication of the time limit for using the device safely. It includes at least the year and month, where this is relevant. In the code, the date format YYMMDD is provided.

No, the manufacturer decides according to QM-specifications if he expresses the date of manufacture in days or months. In the code, the date format YYYYMMDD is provided.