The medical device industry is subject to rigorous regulations, and obtaining approval from a notified body is crucial for manufacturers seeking to market their products in the European Union. [1] A notified body is an organization designated by the EU to assess the conformity of medical devices with the relevant requirements of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). [2]
This article outlines 10 easy steps to prepare for and successfully navigate a notified body inspection, ensuring compliance with ISO 13485 and other applicable standards, while addressing common findings to streamline the process of obtaining the coveted CE mark for medical devices and maintaining regulatory approval in the EU market. [3]
Preparing for the Notified Body Inspection
To prepare for a Notified Body inspection, manufacturers must take several crucial steps:
1. Apply for Designation:
The conformity assessment body (CAB) should use the relevant application form provided on the competent authority’s website to apply for designation as a Notified Body (NB). [1]
2. Completeness Check:
The competent authority will perform a completeness check within 30 days of receiving the application and may request additional information. [1]
3. Preliminary Assessment:
The competent authority will complete a preliminary assessment report, aiming to do so within 4-6 weeks after the completeness check. [1]
4. Choose the Right NB:
Notified Bodies (NBs) are third-party entities accredited by EU member states to assess the conformity of medical devices. Manufacturers must choose the appropriate NB designated for their specific device category and ensure a good working relationship with them. [2]
5. Understand NB Processes:
NBs have their own documented processes and procedures for conducting conformity assessments, which can vary. Manufacturers should understand a NB’s processes before engaging with them. [2]
6. Implement a QMS:
Using a purpose-built quality management system (QMS) like Greenlight Guru can help medical device companies efficiently manage the NB audit process and have all necessary information readily available. [2]
7. Prepare Documentation:
Manufacturers should be prepared to provide documentation such as Clinical Development Plan, Clinical Evaluation Plan, Clinical Evaluation Report, Post-Market Surveillance Plan, and Post-Market Clinical Follow-Up Plan. [6]
8. Conduct Internal Audits:
Conducting thorough internal audits and management reviews are key to identifying and addressing issues before the Notified Body audit. [7]
9. Mock Audits:
Manufacturers should conduct mock audits to simulate processes like complaint handling and post-market surveillance to demonstrate their system is working. [7]
10. Prioritize Complex Products:
Aim to audit the most complex products first, as this will make it easier for other products. [7]
Need help with Notified Body Inspection?
Take the next step in ensuring quality and compliance for your medical devices with our expert consultation services for MDR/IVDR.
Set an appointmentDuring the Inspection
During the on-site assessment, the notified body conducts conformity assessments against the relevant EU Directives and reviews the manufacturer’s technical documentation and quality system. The assessment is carried out by the HPRA (Health Products Regulatory Authority) together with a Joint Assessment Team (JAT) appointed by the European Commission. [1]
Key areas that are likely to be scrutinized by the notified body include:
Clinical data and evidence
Intended purpose of the device
Equivalency claims made by the manufacturer
Labeling requirements
Performance testing data
Benefit-risk analysis
Postmarket surveillance data [10]
The notified body is required to:
- Assess the technical documentation based on a predefined sampling plan, considering factors such as risk, novelty of technology, manufacturing complexity, and previous assessment results. [10]
- Evaluate the product’s compliance with the General Safety and Performance Requirements (GSPR). [10]
- Consider requirements related to preclinical testing and clinical evaluations. [10]
During the audit, manufacturers should:
- Manage the process as much as possible, sharing only the information specifically requested. [8]
- Address any missing or incorrect information transparently. [8]
If non-compliances are identified, the CAB (Conformity Assessment Body) must submit a corrective and preventive action (CAPA) plan within the deadline set by the HPRA. The CAPA plan will be assessed to determine if it adequately addresses the non-compliances. [1]
Common Inspection Findings
Changes Affecting Designation
Notified Bodies (NBs) must inform the Competent Authority responsible for their designation without delay of any changes that could affect their ability to cover the Annexes and product range they are designated for. [11]
Reporting Obligations
NBs must report any certificates they have suspended or withdrawn to the Competent Authority and other NBs. They must also provide information about certificates issued or refused, and any other relevant information, upon request. [11]
Oversight by Competent Authority
- The Competent Authority will perform initial and surveillance audits of the NB and its subcontractors at least every 18 months to check compliance. [11]
- The Competent Authority may also perform observed audits of the NB during manufacturer assessments and spot checks on specific cases reported to them. [11]
Maintaining Independence and Competence
NBs must maintain independence, impartiality, and competence in assessing medical devices, and have appropriate facilities, procedures, and quality systems in place. They must also properly manage any subcontractors used, maintain confidentiality, and have liability insurance. [11]
Conformity Assessment and Certification
- Manufacturers must undergo a conformity assessment procedure by an NB before affixing the CE mark to their medical device, except for the lowest risk class devices. [12]
- Before the expiry of the certificate’s period of validity, the manufacturer must submit a renewed application to the NB to maintain the certification (re-certification). [12]
Common Audit Findings
- Lack of clarity or specificity in addressing new regulatory requirements during the NB’s Stage 1 audit. [2]
- Inadequate addressing of general obligations under MDR Article 10, such as technical documentation, post-market surveillance, clinical evaluation, and risk management. [2]
- Non-compliance with MDR Article 7 requirements around claims and representations in marketing collateral. [2]
- Lack of clarity on intended use, device history, variants, and bill of materials in the device description and specification. [13]
- Inclusion of irrelevant standards or failure to reference the latest versions in the device description and specification. [13]
- Lack of justification for representative worst-case device selection for testing. [13]
- Failure to include a comprehensive list of all relevant standards used for testing. [13]
- Lack of design validation testing for the product lifetime. [13]
- Failure to provide a documented risk management plan for each device. [13]
- Inadequate addressing of risks associated with time, process, and clinical use. [13]
- Lack of clarity on how General Safety and Performance Requirements (GSPR) sections have been addressed in labeling and IFU. [13]
- Lack of justification for why certain GSPR sections were identified as applicable or not applicable. [13]
NBs are strictly adhering to MDR regulations and expecting quick corrections, leaving manufacturers scrambling to comply. NBs are not exhibiting leniency and will not accept documentation that only embraces the spirit of the regulation but has technical gaps. [13] If audit findings are received, manufacturers should understand the findings, discuss them with the auditor if needed, and address them diligently with a satisfactory plan for correcting and preventing the identified issues. [8]
Conclusion
The journey towards achieving and maintaining regulatory compliance for medical devices in the EU market is a rigorous one, but by following the outlined steps and addressing common pitfalls, manufacturers can increase their chances of a successful notified body inspection. A well-prepared quality management system, thorough documentation, and diligent adherence to the requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial for navigating this process smoothly.
Ultimately, the notified body inspection is a necessary step to ensure the safety and efficacy of medical devices, and manufacturers must approach it with utmost seriousness and attention to detail. To further streamline your path to compliance, consider scheduling a consultation with our experts, who can provide personalized guidance and support throughout the inspection process.
FAQs
How Can I Obtain CE Marking for My Medical Device?
To secure CE marking for your medical device, follow these steps:
- Determine the classification of your medical device.
- Appoint a person responsible for regulatory compliance.
- Establish a quality and risk management system.
- Compile the necessary technical documentation.
- Set up a supplier management system.
- Perform a clinical evaluation of the device.
What Does the Notified Body Process Entail?
The notified body process involves an organization, designated by an EU country, assessing the conformity of specific products before they are marketed. These organizations perform tasks related to the conformity assessment procedures required by applicable legislation, particularly when third-party assessment is necessary.
What Are the Regulations Surrounding CE Marking?
When applying the CE marking, it’s crucial to:
- Use the CE marking exclusively to indicate conformity with the relevant EU directives.
- Avoid any markings or signs that could mislead or confuse third parties about the meaning or form of the CE marking.
- Ensure that other markings on the product do not obscure the CE marking.
What Are the Key Steps in Developing a Medical Device?
The development of a medical device involves several critical steps, including:
- Ideation of the initial concept.
- Design of the product.
- Creation of prototypes.
- Testing of the device.
- Verification and validation of the design.
- Manufacturing of the medical device.
References
[1] – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-notified-bodies-designation-process.pdf?sfvrsn=7
[2] – https://www.greenlight.guru/blog/selecting-notified-body
[3] – https://www.bsigroup.com/LocalFiles/EN-AU/ISO%2013485%20Medical%20Devices/BSI-md-notifed-body-guide-brochure-AU.pdf
[4] – https://lne-gmed.com/notified-bodies-role
[5] – https://health.ec.europa.eu/system/files/2022-02/mdcg_2022-3_en.pdf
[6] – https://www.orielstat.com/blog/medical-device-clinical-audit/
[7] – https://easymedicaldevice.com/notified-body-audit/
[8] – https://www.rimsys.io/blog/medical-device-audits-preparation-and-responses
[9] – https://d2evkimvhatqav.cloudfront.net/documents/MD_Unannounced_Audits-2014.pdf?v=1594929773
[10] – https://www.orielstat.com/blog/eu-notified-body-review-mdr-technical-documentation/
[11] – https://ec.europa.eu/docsroom/documents/10291/attachments/1/translations/en/renditions/native
[12] – https://laegemiddelstyrelsen.dk/en/devices/notified-bodies/
[13] – https://www.rqmplus.com/blog/top-4-findings-from-notified-body-technical-documentation-audits-under-eu-mdr
[14] – https://premier-research.com/blog-medical-device-and-ivd-insights-mastering-the-7-steps-of-the-ce-certification-process/
[15] – https://link.springer.com/10.1007/978-3-031-22091-3_1
[16] – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531632/
Mehrnaz Bozorgian
Computer System Validation Specialist
