September 16, 2022
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance covering surveillance activities required of Notified Bodies under Article 110 of the In Vitro Diagnostic Medical Devices Regulation (IVDR). In addition, the MDCG has clarified guidelines for when Notified Bodies should involve expert panels for certification of some high-risk IVD devices.
Article 110 IVDR and legacy IVDs
First, MDCG guidance MDCG 2022-15 identifies Notified Body surveillance obligations including quality management system documentation reviews and audits for IVD manufacturers whose products will remain on the European market through May 2025 as “legacy” devices; these devices are CE Marked according to the In Vitro Diagnostic Medical Devices Directive (IVDD). Article 110 of the IVDR carves out this allowance in a similar way that the Medical Devices Regulation (MDR) does for some medical devices certified under the Medical Devices Regulation (MDD).
Manufacturers whose IVDs will remain on the European market under legacy CE certification must maintain quality management systems (QMS) according to IVDD requirements. Notified Bodies will verify the following QMS-related components:
- Whether the scope of IVD devices under the IVDD CE Mark is unchanged, or if any devices have been discontinued;
- Whether the manufacturer has adjusted its QMS based on Article 110 IVDR requirements regarding significant changes;
- Whether the manufacturer has adjusted its QMS regarding post-market surveillance, vigilance and registration according to IVDR requirements;
- Whether processes including risk management and performance data feed into the manufacturer’s post-market surveillance plan.
MDCG 2022-15 applies to Notified Bodies designated to issue CE certificates under the IVDD, regardless of whether these entities have obtained designation to the IVDR.
Expert panels and Class D “first-certification” IVDs
Second, the MDCG has revised its MDCG 2021-22 document regarding when Notified Bodies should consult with expert panels for certification of Class D IVD devices under the IVDR.
The revision includes six explanatory notes clarifying when expert panel consultation is required:
- Additional intended purpose of a Class D IVD that falls outside the parameters of Rule 1 or Rule 2 of IVDR Annex VII;
- Automated and semi-automated IVDs;
- Technology considerations;
- Multiplex and single analyte IVDs;
- Kits and Class D components of kits;
- Control materials.
These clarifications for Notified Bodies should also help inform Class D IVD manufacturers in terms of what to provide as well as expect during conformity assessments in order to obtain CE Mark certification under the IVDR.