August 17, 2021
European regulators have recently issued new guidelines and instructions related to drug-device combination products, medical device clinical investigations and performance evaluations of IVD devices used for COVID-19 testing.
EMA guidelines for drug-device combination product quality documentation
First, the European Medicines Agency (EMA) has recently published guidelines covering quality documentation requirements for drug-device combination products, or DDCs.
The EMA guidelines explains quality requirements that DDC manufacturers must address in their marketing authorization dossiers. These requirements specifically apply to products whose principle actions come from medicinal rather than device components, as laid out in Directive 2001/83/EC; Regulation (EC) 726/2004; and Article 117 of the European Medical Devices Regulation (MDR). These requirements pertain to three main configurations of DDC products—integral, co-packaged as well as referenced.
The EMA guidelines take effect January 1, 2022.
MDCG instructions for CIV-ID numbers for MDR clinical investigations
Second, the European Commission’s Medical Device Coordination Group (MDCG) has issued instructions for how to generate European Union-wide tracking numbers known as CIV-IDs for use in identifying individual clinical investigations according to MDR requirements before the Eudamed medical device database comes fully online.
The latest MDCG instructions continue the CIV-ID generation process previously in place under the European Medical Devices Directive (MDD); once Eudamed fully launches, Single Identification Numbers (SIN) will be generated for clinical investigations.
Under the CIV-ID process, a European Competent Authority generates a CIV-ID, which is then provided to a medical device clinical study sponsor. The sponsor may then use its CIV-ID for all necessary clinical investigation documentation and submission activities.
Performance evaluations of COVID-19 IVD tests
Third, the MDCG has also published guidance on conducting performance evaluations of IVD devices used for COVID-19 testing.
The guidance covers performance evaluation factors for these IVDs related to conformity assessment, with the aim of establishing a basis for future common specifications for such products according to Article 9 of the European In-vitro Diagnostic Medical Devices Regulation (IVDR).