New EU Implementing Regulation Introduces Greater Predictability for Conformity Assessment
The European Commission has adopted Implementing Regulation (EU) 2026/977 of 4 May 2026, introducing uniform quality management and procedural requirements for conformity assessment activities carried out by notified bodies under the EU medical device framework.
The Regulation aims to address longstanding concerns related to unpredictability, inconsistency, and administrative burden within the European conformity assessment system.
According to MedTech Europe, the measure represents an important short-term step while broader revisions of the MDR and IVDR continue to be discussed at EU level.
Key Changes Introduced by the Regulation
Defined Conformity Assessment Timelines
The Regulation establishes defined maximum timelines and strengthened procedures for key assessment phases, including:
application review,
product assessment,
certification decisions.
According to MedTech Europe, this is expected to provide manufacturers with clearer visibility on timelines and costs when planning certification activities.
Reduced Administrative Burden
The new rules also introduce measures intended to reduce duplicative administrative work.
Under the Regulation:
notified bodies will be required to provide estimated timelines during the quotation stage,
manufacturers will no longer need to resubmit unchanged information for repeat procedures.
Safeguards Against Procedural Refusals
The Regulation states that conformity assessments must be completed on their merits and should not be refused solely on procedural grounds, including:
expired timelines,
use of interruption mechanisms.
Potential Benefits for SMEs and Innovation Planning
MedTech Europe stated that more consistent and transparent procedures may help companies, particularly SMEs, plan:
investments,
innovation pipelines,
market-entry strategies,
with greater confidence.
The organisation also noted that the changes could support European competitiveness and timely patient access to medical technologies.
Industry Focus Now Shifts to Implementation
MedTech Europe emphasised that implementation across the EU will be critical to ensuring that the new requirements translate into:
faster assessments,
improved transparency,
more efficient conformity assessment procedures in practice.
The Implementing Regulation is intended to complement the ongoing targeted revision of the MDR and IVDR currently under discussion within the European Parliament and Council.
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