Background

The Commission is in the process of amending the medical device and IVD regulatory system in Europe. The MDR and IVDR implementation has been fraught, with multiple postponements across the last 6 years; delays to systems, guidance, and harmonized standards required to ease the process; increased cost; and concerns that the European market is losing competitiveness.

One solution is the proposal to significantly reform the MDR and IVDR. However, other solutions have been presented, including this new regulation.

The Commission:

Purpose of Regulation 2026/977

The new regulation is intended to supplement the Notified Body (NB) requirements outlined under Annex VII of the MDR and IVDR, and to explicitly outline certain minimum requirements across all the MDR/IVDR Notified Bodies. It aims to create transparency, accountability, and harmonize activities across the 50+ Notified Bodies.

Harmonization

Currently, Notified Bodies have different practices for collecting information for quotes, how they communicate with manufacturers, and processes on how they move from one stage of the conformity assessment process to another. The regulation seeks to reduce the wide variations between the NBs, so all manufacturers have a more consistent experience, irrespective of which Notified Body they select.

Transparency & Accountability

The regulation seeks to provide clarity by having NBs provide clearer, more understandable pricing, and have a maximum certification timeframe built into the contract with the manufacturer.

Further, the regulation requires NBs to track and measure their results. They must implement a mechanism to compare the timelines and costs provided in their quotes, against the actual timing and costs charged in the end. Not only do they need to internally assess this each year, but they must also publish this information to their websites.

Article 1: Quotations

Information Required for the Quote

The regulation stipulates the minimum information required from the manufacturer for a quote. This list is not so different from what most NBs request today. However, this ensures that each NB is requesting the minimum information required, in order to ensure a more accurate quotation.

Information requested includes size of the company (micro, small, or mid-sized), name of the Authorized Representative, number of employees, number of work shifts, description of activities performed at each site included in the QMS, name and address for all relevant suppliers and subcontractors, and description of the device.

For changes or recertification, the NB shouldn’t re-ask for the above information, as long as the manufacturer confirms that there have been no changes.

Information Required in the Quote

The quote must include, at minimum, the following:

Further, the NB must inform the manufacturer in advance about any increase above 10% of the estimated fee, providing a reason for the increase.

Structured Dialogs

The regulation also notes the use of structured dialogues. There is no additional fee to partake in structured dialogues. Therefore, it’s in the manufacturer’s best interest to request these, especially if their device or company structure is complicated.

This allows the NB to provide a more accurate fee and time estimate, so that manufacturers better understand their true time and cost to market. And are less likely to be hit with surprise extensions or additional costs after the contract is signed.

Articles 2-3: Timelines

Notified Bodies must implement procedures to ensure the shortest possible timeline to complete the certification process. The actual timeframe agreed with each manufacturer may vary depending on the type of devices, scope of activities, etc. However, it must not exceed the maximum timeframes allowed under the regulation.

Expiration of the maximum timeframes is not a sufficient reason for the NB to refuse to issue a certificate or approve a change. I.e., the NB must make a decision within the maximum timeframe.

Interruption of Timeline (“clock-stops”)

The maximum timeframes can be interrupted for necessary reasons, i.e., when the manufacturer needs to address non-conformities or if the NB has justified questions/requests necessary for the assessment.

However, there are a maximum number of clock-stops allowed:

Max Interruptions Allowed	Activity
One time	Application review and the signature of the contract
Four times	Initial QMS auditing
Four times	Initial product verification
Five times	To review the substantial changes and for the conformity assessment activities related to such change, if required
Three times	Re-certification for product certification and/or the QMS
One time	Decision and issuance of any certificates

QMS and Product Verification

At the very least, the agreed upon timeframe should not exceed the below maximum timelines.

The regulation further notes that:

Max Days	Activity	Duration	Max Interruptions
30 days	Application review and the signature of the contract	Starts the day the NB receives the complete application.	One time
120 days	Quality management system auditing	Starts the day the NB initiates the audit program’s first activity and ends on the day when the final review is completed.	Four times
90 days	Product verification	Starts the day the NB initiates the assessment of the technical documentation of each device, or each representative device, and ends on the day when the final review is completed.	Four times
20 days	Decision and certification	Starts the day after the completion of the last relevant final review and ends on the day the certificates are issued and entered into EUDAMED.	One time

 Substantial Changes

Notified Bodies are required to assess substantial changes within the following maximum timeframes:

Max Days	Activity	Duration	Max Interruptions
30 days	Review the proposed change	Starts the day the NB receives completed documentation of the proposed change and ends on the day the NB notifies the manufacturer of the decision 1) on whether any additional conformity assessment activities are needed, or 2) of the approval of the planned change.	5 times total, combined with the conformity assessment activity, if required
90 days	Conformity assessment activities for the planned change	Starts the day the NB initiates the audit program’s first activity, or on the day the notified body initiates the assessment of the technical documentation, whichever is the earlier, and ends on the day when the NB notifies the manufacturer of the approval.	5 times total, combined with review of the planned substantial change
20 days	Issuing of the supplement to the certificate(s)	Starts the day after notification of the approval and ends on the day the certificates are issued and entered into EUDAMED.	One time

Caveats and Exceptions

Where the NB and manufacturer agree on a rolling review of the technical documentation, they shall agree on a plan for submitting parts of the technical documentation and possible additional interruptions.

Additionally, the NB may use two additional clock-stops to the initial QMS assessment for each additional site covered by the manufacturer’s QMS, to be audited on-site.

Interruptions due to opinions required by the European Medicines Agency (EMA), a regulatory authority, an expert panel, or an EU reference laboratory do not count, i.e., are not included in the maximum number of interruptions allowed.

The duration of any interruptions can only be extended if duly justified and the NB and manufacturer agree to the extension in writing.

Article 4: Monitoring of Duration and Costs

Each NB must establish a system to monitor 1) the duration of conformity assessment activities, and 2) their costs.

The assessment must include:

This assessment must be completed annually, and published to each NBs website no later than 30 April of each year.

Note on Costs

The regulation does not enforce maximum costs. So, there can still be a wide fee-range between the NBs. However, the regulation allows easier comparison, as the quotes must be presented in a clear and transparent manner. And over time, as the data is published to each NBs website, manufactures can compare the median cost and time between each NB.

Articles 5-7: Recertification

Recertification Process

The regulation outlines the minimum information needed for recertification.

For product recertification, these include:

It also outlines what the NB should consider during recertification, such as:

Re-certification Timeframes

The maximum timeframes for the recertification process are:

Max Days	Activity	Max Interruptions
90 days	Product verification	Three times
90 days	QMS	Three times
20 days*	Decision and certificates reissued	One time

*Where the decision is made more than three months before the certificate expiration date, the maximum period of 20 days shall start three months before the certificate’s expiration date.

Articles 8-9: Application Date and Transitional Period

The regulation includes a transition period, to allow Notified Bodies to amend their processes, documentation, etc, to comply with the new requirements.

Activity	Start Date
Entry into force	24 May 2026
Date of application for most requirements	25 February 2027
Date of application for the requirement to publish annual data to each NB’s website	1 January 2028 (making the first publication due by 30 April 2029)
Transition period for Articles 1 (quotation), 2 (max timeframes), and 3 (“clock-stops”)	New requirements apply to agreements signed after 25 February 2027
Transition period for Article 4(1)-(3) (implementing a system to monitor timelines and cost)	New requirements apply to agreements signed after 25 May 2027
Transition period for Recertification	New requirements apply certificates expiring after 25 November 2027