Pharmaceutical Product Number (PZN) for Medical Devices
sananet management consultancy supports medical device manufacturers in obtaining a PZN (Pharmaceutical Product Number).
When applying for a PZN (Pharmaceutical Product Number) for medical devices, sananet follows a clearly defined process, which we outline below.
What is a PZN?
The Pharmaceutical Product Number (PZN) is a standardised, nationwide 8-digit identification code used in Germany for medicinal products, medical devices and other goods commonly sold in pharmacies.
It is assigned by IFA GmbH (Information Centre for Pharmaceutical Specialities).
For medical devices, the PZN plays a key role in national logistics and in billing statutory health insurance providers through pharmacies and medical supply stores.
The Function of the PZN for Medical Devices
As a PZN (Pharmaceutical Product Number) can be essential for the distribution of certain medical devices in Germany, sananet management consultancy supports medical device manufacturers in obtaining a PZN through IFA.
The PZN essentially serves three purposes:
- Unique identification: It assigns specific parameters to a medical device, including the manufacturer, product name, pack size and product variant.
- Billing and reimbursement: When a medical device (e.g. wound dressings, blood glucose test strips or inhalation devices) is prescribed as a medical aid or as part of a prescription, billing with health insurance providers is processed using the PZN. The PZN is therefore also essential for medical aids. sananet management consultancy also assists manufacturers in obtaining a medical aid number (Hilfsmittelnummer).
- Inventory management: It controls the entire ordering and delivery process between manufacturers, pharmaceutical wholesalers and pharmacies.
How Does the PZN Relate to the EU MDR?
Since the European Medical Device Regulation (EU MDR 2017/745) came into force, medical devices have been required to carry a globally unique product identifier – the UDI (Unique Device Identification).
As the PZN is a purely German identification number, IFA has established a system to connect the two identification systems:
- The European Commission has officially designated IFA GmbH as an issuing entity.
- To enable the national PZN to be used internationally and in compliance with the MDR as a UDI-DI (Device Identifier), it is converted into what is known as the PPN (Pharmacy Product Number). The PPN consists of the product registration prefix for Germany (11), the 8-digit PZN and two check digits.
- This allows medical device manufacturers to use IFA to convert an existing or new PZN directly into a UDI-compliant system without having to establish entirely new numbering structures for the German pharmacy market.
Which Medical Devices Can Obtain a PZN?
In principle, sananet can assist you in obtaining a PZN for all medical devices intended for distribution through pharmacies or medical supply stores. The assignment of a PZN is closely linked to the status of being a product customarily sold in pharmacies, as defined in Section 25 of the German Pharmacy Operating Regulations (Apothekenbetriebsordnung – ApBetrO).
First, sananet checks whether the following criteria are met before a PZN application can be submitted for a medical device:
- Conformity and marketability: The product must bear a CE mark and comply with the requirements of the EU MDR (or IVDR for in vitro diagnostic medical devices). It must be legally marketable and available for sale in Germany.
- Suitability for pharmacy distribution: The product must be a type of item typically distributed through pharmacies or medical supply stores. These commonly include:
- Medical aids and care aids (e.g. incontinence products, compression stockings)
- Dressings and wound care products (e.g. plasters, sterile compresses, fixation bandages)
- In vitro diagnostic medical devices (e.g. blood glucose test strips, COVID-19 rapid tests)
- Application aids and medical devices for administration (e.g. inhalers, insulin syringes)
- Finished product: The product must be available on the market as a ready-to-use commercial product in standard or hospital packaging.
How Does sananet Assist with the PZN Application Process through IFA?
sananet handles the application process exclusively online via IFA GmbH (Information Centre for Pharmaceutical Specialities). To submit an application on behalf of a medical device manufacturer, sananet requires a power of attorney.
Our PZN application process through IFA consists of three main phases:
Phase 1: Conclude an IFA Supplier Agreement (For New Customers)
Before product numbers can be submitted, your company (manufacturer, distributor or importer) must become an official contractual partner of IFA. Once the IFA supplier agreement has been concluded, you will receive a customer number and access to the IFA portal.
Phase 2: Preliminary PZN Assignment (Optional, but Recommended)
If packaging artwork needs to be printed before the medical device is officially launched on the market, sananet recommends requesting a PZN assignment without immediate publication.
Phase 3: Initial Product Registration for Publication (Market Launch)
For pharmacies and wholesalers to be able to order the product and process billing, the complete product data must be entered into the IFA database. This is particularly important for the reimbursement of medical aids listed in the German Medical Aids Directory (Hilfsmittelverzeichnis).
On your behalf, sananet submits all relevant product master data via the IFA portal, including the exact product name, pack size, pricing information, product type (“medical device”) and UDI details.
IFA publishes verified product data on the 1st and 15th of each month. Strict editorial deadlines apply (usually several weeks in advance) to ensure that the data is available in pharmacy systems in time.
