EU Commission proposes new timelines for notified bodies
The European Commission has proposed setting expectations, including timelines, that notified bodies should meet when conducting conformity assessments of medical devices and in vitro diagnostic products. The Commission stated that the proposal aims to establish a more predictable regulatory environment for manufacturers in the European Union.On 12 December, the Commission published a draft implementing regulation outlining the need to set specific quotation and timeline requirements that notified bodies must meet to ensure greater regulatory consistency and predictability. It stated that there have been “inconsistent and divergent” interpretations by notified bodies of requirements under the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostics Regulation (IVDR) regarding quotations, conformity assessment timelines, and recertifications. It further stated that notified bodies’ quality management and procedural requirements also significantly diverge, leading to unequal treatment of manufacturers in the market.
“This is particularly relevant in case of manufacturers that are small and medium-sized enterprises,” the Commission wrote. “Such practices have an impact on the predictability and on the timely completion of conformity assessment activities, with significant repercussions and delays for innovation and the health of patients.
“Notified bodies showed significantly differing practices when issuing quotations to manufacturers for specific conformity assessments,” the Commission added. “As a result, manufacturers are not provided with a reliable estimation of the overall requested services and costs.”
The proposed implementing regulation aims to harmonize notified body practices, which, among other factors, should specify the minimum information required of manufacturers to issue a quotation and the timelines intended to be followed, according to the Commission. Furthermore, notified bodies should request specific information from manufacturers about their product’s intended purpose, any unique characteristics, or the technologies or processes used, so they can verify that the product is designated for the corresponding codes in the regulation.
“Notified bodies have developed varying practices for interacting with manufacturers, leading to different procedures for setting timelines for the conformity assessment activities,” said the Commission. “This results in conformity assessment activities being completed across a wide range of timelines, often lacking a clear rationale for how these timelines are determined.”
When setting timelines, the Commission said that the notified bodies should factor in the range and type of device, its specific characteristics and technology, its risk classification, and the conformity assessment activities that need to be performed. Ultimately, the notified body would have to specify the agreed timeline in its quotation to the manufacturer.
The Commission has proposed maximum timelines for notified bodies to follow, including 30 days to review applications and sign contracts, 120 days to conduct quality management system audits, 90 days to conduct and verify an assessment of the technical documentation of the device or the representative device, and 15 days to issue a final decision and certification after conducting a final review.
The implementing regulation also includes proposed maximum timelines for notified bodies to complete assessments of planned substantial changes to the manufacturer's quality management system or to the device range. The Commission proposed requiring notified bodies to complete proposed planned change reviews within 30 days, 90 days to complete additional conformity assessment activities related to the planned change, and 15 days to issue a supplement to the relevant certificate.
Comments on the proposed regulation can be made through 23 January 2026 on the Commission's website.
Draft implementing regulation
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