Common Mistakes When Undergoing MDR Notified Body Agreements

The revised transitional provisions of the MDR allow for the following devices to be placed on the market or put into service until the following dates indicated so long as several conditions are fulfilled:

One of the conditions that must be fulfilled is that by no later than 26 May 2024, the manufacturer or authorized representative must have lodged a formal application with a Notified Body for MDR conformity assessment and that no later than 26 September 2024 the Notified Body and manufacturer must have a signed written agreement in place. With 26 May 2024 fast approaching, manufacturers looking to take advantage of these transition timeline extensions have been actively reaching out to Notified Bodies to lodge formal applications. 

In this article we provide an overview of general mistakes made by manufacturers when attempting to obtain a signed agreement with a Notified Body. 

Finding an Appropriate Notified Body

EU Notified Bodies must apply for and complete the respective designation process in order to be authorized for product conformity assessment activities per the applicable EU legislation. One general mistake made by manufacturers is not identifying a Notified Body that can meet all of their conformity assessment requirements. Therefore, the first port of call for manufacturers looking to obtain a signed Notified Body agreement is the New Approach Notified and Designated Organizations (NANDO) information system. A ‘Search by Legislation’ in this database allows manufacturers to readily identify those Notified Bodies designated under the MDR (44 Notified Bodies as of March 2024). 

Considerations When Choosing a Notified Body

However, the applicable legislation under which the Notified Body has been designated is not the only factor for consideration. Notified Bodies have varying capabilities (and capacities) for conformity assessment under the MDR, therefore their designation under the MDR is also established with the following scope considerations: 

• • • Conformity assessment procedures (per the options provided under Annexes IX, X and XI of the MDR) 
    • Products 
    • Horizontal technical competence 

As such, when assessing candidate Notified Bodies, manufacturers are recommended to review the scope of their designations to ensure that all of their devices are covered to minimize the number of Notified Bodies that may be necessary. 

Multiple EU Legislation Requirements

Additionally, certain devices may fall under more than one EU legislation requiring conformity assessment which may also subsequently require Notified Body involvement. In such cases, manufacturers are also recommended to review NANDO to identify appropriately designated Notified Bodies. Such other EU legislation may include: 

• • • Machinery Directive 2006/42/EC (repealed from 20 January 2027) / Machinery Regulation 2023/1230 (applicable from 20 January 2027 although several articles are subject to transitional application prior to this date) 
    • Radio Equipment Directive 2014/53/EU 
    • Pressure Equipment Directive 2014/68/EU 
    • Personal Protective Equipment Regulation 2016/425 

As the above is not intended to be a comprehensive list of other EU legislation potentially applicable to devices that may require Notified Body involvement, manufacturers are recommended to consult the full list of legislation in the NANDO database. 

Conformity with Other Transitional Provisions

As stated at the start of this article, there are several conditions that must be fulfilled for manufacturers to be able to take advantage of the extended timeframes for placing MDD CE certified devices on the market or putting them into service. Another general mistake made by manufacturers is not ensuring that all of these conditions are fulfilled. 

Notified Body Agreement Deadlines

In addition to the Notified Body agreement deadlines previously mentioned, the other conditions include: 

MDD Declaration of Conformity (DoC) Requirements

For devices that were self-certified under the MDD but require Notified Body involvement under the MDR, the MDD Declaration of Conformity (DoC) must have been drawn up prior to 26 May 2021. To ensure ongoing conformity with this requirement, it is recommended that where corrections/changes are necessary to a MDD DoC drawn up prior to 26 May 2021 (e.g. change in EU Authorized Representative) that such corrections/changes be documented in addendums to the original DoC. 

Continued compliance of the device with the MDD 

This means that while transitioning devices to MDR-compliant technical files to be submitted for Notified Body review, manufacturers should ensure that they continue to maintain sufficient technical documentation demonstrating conformity with the MDD (e.g. Essential Requirements Checklist). 

Design and Intended Purpose of the Device

No significant changes in the design and intended purpose of the device. While manufacturers should have robust change controls established within their quality management system (QMS) framework, it is essential that manufacturers keep track of any changes that have been made to the design and intended purpose of their device after 26 May 2021 and ensure ongoing conformity with this requirement. Guidance on significant changes is established in MDCG 2020-3 Rev. 1 and it is strongly recommended that manufacturers align their design change control procedures so that change impact assessments for the purposes of conformity with EU requirements are performed in a manner aligned with this guidance. 

Health and Safety Risks

Devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. This condition is directly related to manufacturers needing to maintain adequate post-market surveillance (PMS) and vigilance procedures and taking appropriate corrective actions where such risks are presented (through Field Safety Corrective Actions (FSCA)). Since the date of application of the MDR (26 May 2021), it has been a requirement of all devices placed on the market or put into service that manufacturers comply with MDR PMS and vigilance requirements. Therefore, all manufacturers must ensure that their PMS and vigilance procedures comply with these requirements. 

Quality Management System (QMS) Requirements

The manufacturer has established a QMS compliant with the requirements of the MDR (Article 10(9)) no later than 26 May 2024. Most manufacturers taking advantage of the transitional timeframe extensions will undergo a Notified Body audit of their QMS as part of the conformity assessment procedure. Such audits typically include a review of document control processes and it is highly likely that as part of their audits, Notified Bodies will verify the dates on which changes were implemented by manufacturers in their QMS to comply with this requirement. While the aspects to be addressed by the QMS, as established under Article 10(9) of the MDR, are aligned with EN ISO 13485:2016 requirements, manufacturers should pay particular attention to ensuring QMS conformity with MDR requirements (and alignment with relevant MDCG guidance) for: 

• • • Regulatory compliance strategy, including device design and change management 
    • Resource management (e.g. management of Person Responsible for Regulatory Compliance (PRRC), economic operators and critical suppliers) 
    • Clinical evaluation (e.g. procedures (and templates) used for clinical evaluation, including standardization of the approach taken for systematic literature searches) and Post-Market Clinical Follow-up (PMCF) 
    • Unique Device Identification (UDI) (e.g. management of Basic UDI-DI assignment) 
    • PMS (e.g. alignment with MDCG 2022-21 on Periodic Safety Update Report (PSUR) compilation) 
    • Reporting serious incidents and FSCAs 

Manufacturers’ Transition to MDR and IVDR

Prior to extension of the MDR transitional timeframes several Notified Bodies had indicated to manufacturers they were not taking on new customers due to resource restrictions which left manufacturers with few options to pursue certification under the new regulatory framework. While this was further exacerbated following the designation of Notified Bodies under the IVDR (which is currently still restricted to only 12 designated Notified Bodies), the timeframe extensions have served to reduce this pressure on Notified Bodies.

The recent history of transition to the MDR (and IVDR) is littered with examples of manufacturers that have dragged their feet in ensuring conformity with the new regulatory framework, particularly manufacturers of devices that continue to be self-certified under the MDR (and IVDR) that left adaptation of their QMS and technical documentation files until the last minute. 

Urgency for Manufacturers to Submit Formal Applications

With that being said, given that (at the time of this article) there are less than two months remaining for the formal application deadline, manufacturers that have not yet submitted a formal application with an appropriate Notified Body and are looking to take advantage of the extended timeframes should urgently consider their current status and submit such an application as a matter of priority. Given the likely significant number of manufacturers looking to take advantage of the timeframe extensions, manufacturers are therefore strongly encouraged to treat their formal applications as a matter of urgency to get ahead of any application processing queues. 

Learn More About Obtaining a Signed Agreement with a Notified Body Under the MDR with MedEnvoy

This article provides an overview of general mistakes for obtaining a signed agreement with a Notified Body under the MDR. If you have any questions regarding this topic, or require MDR (or IVDR) consulting support or an EU Authorized Representative, get in touch. 

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