The EU Medical Device Coordination Group has published two sets of guidance in April for manufacturers.
Unique Device Identification (UDI) guidance (MDCG 2018-1) has been prepared to ensure products adhere to 2017 legislation. A single Basic UDI-DI will apply to a single product, and will be its main database identifier. The UDI does not need to appear on any trade item or packaging. In order to ensure minimal confusion and ambiguity between products, the guidance states:
“a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilization before use, quantity of devices provided in a package, critical warnings or contra-indications (e.g. containing latex or EHP), CMR/Endocrine disruptors, colour, language”.
Medical device nomenclature guidance (MDCG 2018-2) provides information for the creation of a nomenclature system within the EU for future devices. The guidance sets out the principles for the system. These include:
- The nomenclature will be free to use for manufacturers
- Names and codes should be present in EUDAMED
- Policies/rules for update, removal and creation of names and descriptions in the nomenclature are to be sound and must reflect regulators’ and the wider healthcare economy needs
- System should avoid “unnecessary granularity” and words/codes used only in a small set of EU economies
The provisions laid out in the guidance should work to ensure a stable, future-proof nomenclature for medical devices in the EU, and should benefit both manufacturers and users.