The In-vitro-Diagnostika-Verordnung, known everywhere by its English abbreviation IVDR, is the European regulation covering in vitro diagnostic devices, and every test strip, cassette and cartridge a pharmacy handles falls under it. The visible result of that regulation is the CE mark on the packaging, and the mark is routinely misread as a quality score or a recommendation. It records only that the manufacturer has taken the product through the conformity assessment route the IVDR prescribes for its risk class.
The part of the mark that matters every day is the Zweckbestimmung, which is the intended purpose the manufacturer declared. It names the sample material and the setting, and decisively it names the intended user of the product. A product released for Laienanwendung has been validated for a lay person using it on themselves, with instructions written for that person. A product released for professional use has been validated for trained hands, so it normally carries different handling steps and different documentation expectations.
That distinction decides what a pharmacy may actually do with a product. Selling a Selbsttest for the customer to use at home is one situation, whereas performing the same measurement on the customer inside the pharmacy is another. That second situation needs a product whose Zweckbestimmung covers use by fachkundiges Personal in the pharmacy. A Schnelltest bought as a self test and then offered as a service on customers is being used outside its declared purpose, whatever the CE mark on the box appears to promise.
The IVDR also raised the evidence a manufacturer has to hold and moved many familiar products into higher risk classes, which is why some of them changed packaging, changed status or left the market. For a pharmacy the practical check is short:
- Read the Zweckbestimmung in the Gebrauchsanweisung before the product is used.
- Confirm that it covers the sample material, the setting and the user.
- Keep that documentation with the device rather than in the carton.
Once the product is right, the MPBetreibV sets the duties that attach to running the device, from instructing staff to logging the checks. Any Point-of-Care-Test offered as a service therefore falls under both regulations at the same time, because one governs what the product is approved for and the other governs how the pharmacy operates it.
This glossary entry is general information about German pharmacy law and practice. It is not legal advice. For binding guidance on your own pharmacy, contact your Landesapothekerkammer.
