#32026R0977EU rules on timelines, costs, and re-certification for medical device notified bodies
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This regulation standardizes how notified bodies assess medical devices and in vitro diagnostic devices in the EU. It sets clearer rules for quotations, maximum assessment timelines, pauses in the review process, annual reporting on costs and timing, and re-certification reviews. Medical device manufacturers should get more predictable pricing and faster, more consistent conformity assessment processes. Notified bodies will need documented procedures, cost and timeline monitoring systems, and annual public reports. Most rules apply from 25 February 2027, with annual reporting obligations starting later.
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Key Changes
- Requires notified bodies to request defined information before issuing quotations and to provide clearer cost breakdowns.
- Sets maximum timelines for application review, quality system audits, product verification, certification decisions, planned changes, and re-certification.
- Requires notified bodies to monitor assessment duration and costs and publish annual reports on their performance.
Obligations
What this law requires
Notified bodies must maintain documented procedures ensuring quotations are issued only after receiving required manufacturer, site, supplier/subcontractor, device, conformity assessment procedure, change, and re-certification information needed to estimate the assessment activities.
For change or re-certification quotations, notified bodies must not request previously submitted manufacturer/device information where the manufacturer confirms that information has not changed.
Notified bodies must ensure structured dialogue and exchanges of technical information and regulatory guidance with manufacturers cover aspects relevant to issuing quotations, including the information required by Article 1(1).
Notified bodies must issue quotations that include estimated overall costs, broken down for quality management system and technical documentation assessment where applicable, typical surveillance and unannounced audit costs, estimated potential extra costs, and estimated timelines.
Notified bodies must inform the manufacturer in advance and provide reasons before increasing charged costs by more than 10% above the estimated costs in the quotation.