Regulation (EU) 2026/977 Introduces New Requirements for Notified Bodies on Timelines, Costs, and Conformity Assessment Procedures under MDR and IVDR

The European Commission has adopted Regulation (EU) 2026/977 laying down rules for the application of Regulations (EU) 2017/745 and (EU) 2017/746 regarding the functioning of notified bodies in relation to conformity assessment activities for medical devices and in vitro diagnostic medical devices. The Regulation establishes requirements relating to application handling, quotations, conformity assessment activities, certification procedures, monitoring of timelines and costs, and reporting obligations. The Regulation will apply from 25 February 2027. However, the requirements relating to the annual reporting of timelines and costs will apply from 1 January 2028.

Key Highlights
• Establishes requirements for the management of applications and contractual arrangements between manufacturers and notified bodies.
• Introduces requirements concerning quotations and the information to be provided for their preparation.
• Establishes timelines for conformity assessment activities performed by notified bodies and for certification decisions and certificate issuance.
• Introduces requirements for the assessment of quality management systems and technical documentation.
• Introduces requirements for the assessment of changes affecting certified devices and quality management systems.
• Specifies conditions under which conformity assessment timelines may be suspended and resumed.
• Requires monitoring of performance indicators related to timelines and costs.
• Establishes annual reporting obligations concerning conformity assessment activities, timelines, and costs.
• Introduces harmonized requirements intended to improve predictability, transparency, and consistency across notified bodies operating under MDR and IVDR.
Impact and Recommendations for Manufacturers
• Manufacturers should review their certification planning and timelines in line with the new conformity assessment requirements.
• Complete and accurate information should be provided during the application and quotation stages to support conformity assessment activities.
• Manufacturers should monitor information published by notified bodies regarding timelines and costs as required under the Regulation.
• The new requirements relating to quotations, conformity assessment activities, and reporting should be considered when planning future MDR and IVDR certification activities.
Impact on Notified Bodies
• Notified bodies must implement the requirements relating to application handling, quotations, contractual arrangements, and conformity assessment activities.
• Monitoring and reporting of performance indicators related to timelines and costs will be required.
• Notified bodies must comply with the harmonized requirements and reporting obligations established by Regulation (EU) 2026/977.

Conclusion
Regulation (EU) 2026/977 introduces uniform requirements for notified bodies conducting conformity assessment activities under MDR and IVDR. By introducing defined timelines, quotations, costs monitoring , and reporting obligations, the regulation aims to improve the predictability, consistency, and efficiency of certification processes with application beginning on 25 February 2027. Manufacturers and notified bodies should evaluate the new requirements and prepare for their implementation in accordance with the timelines set out in the Regulation.

Source:
Official Journal of the European Union - Commission Implementing Regulation (EU) 2026/977:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600977

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This release was published on openPR.