Transfer CE Certificate to Another Notified Body – Complete Overview
Navigating the European medical device regulatory landscape can be complex, especially when it comes to CE certification and transferring it to another Notified Body. Whether you’re new to the industry or refreshing your knowledge, understanding the lifecycle of a CE certificate and the transfer process is crucial.
In this guide, we walk you through key stages, answer common questions, and clarify important concepts—all in a friendly and easy-to-understand manner.
Learn more: CE Marking for Medical Devices
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What is the lifecycle of a CE Certificate?
A CE certificate is a mark of conformity indicating that a medical device meets EU safety, health, and environmental protection requirements.
- The lifecycle begins with a conformity assessment conducted by a Notified Body, as per EU MDR 2017/745 or IVDR 2017/746, depending on your device.
- Once granted, a CE certificate is typically valid for five years.
- Manufacturers must maintain regulatory compliance, including ISO 13485 quality management system standards.
- Regular audits and assessments ensure ongoing adherence, forming a continuous loop of compliance during the certificate’s validity.
What is the process of renewal and when does it start?
Renewal is essential to continue marketing your medical device in the EU after the initial five-year period.
Key points for renewal:
- Start early: Begin at least six months before certificate expiry.
- Documentation review: Notified Body evaluates updated technical documentation, device changes, and manufacturing modifications.
- Audits: May include on-site assessments to ensure compliance.
- Compliance check: Confirms adherence to current EU MDR/IVDR standards and ISO 13485.
Why is there still renewal and not continuous surveillance by Notified Bodies?
- Surveillance audits: Conducted annually to monitor ongoing compliance.
- Renewal audits: More comprehensive, reassessing the device and quality system thoroughly.
- Ensures cumulative changes over five years haven’t introduced non-compliances.
- Continuous surveillance cannot replace formal renewal; renewal aligns with latest regulatory updates.
Can you combine MDR surveillance and renewal activities?
Yes! Combining MDR surveillance and renewal audits is efficient and resource-saving:
- Conduct both audits together to reduce duplication.
- Ensures all aspects of compliance are reviewed cohesively.
- Can also align with MDSAP certification audits if applicable.
Learn more: MDSAP certification
Which Changes Must Be Reported Before You Transfer CE Certificate to Another Notified Body?
Manufacturers must notify their Notified Body about significant changes affecting device conformity:
- Changes to intended use or performance
- Design or material modifications impacting safety or effectiveness
- Updates to manufacturing processes or suppliers (e.g., new sterilization provider)
- Adjustments to quality management system affecting compliance
Minor changes may not require immediate notification but should be documented internally.
How can I transfer CE certificate to another Notified Body?
Transferring your CE certificate is a structured process to ensure continuity and compliance.
Reasons for transfer:
- Dissatisfaction with current services
- Changes in Notified Body designation under MDR or IVDR
Legal basis:
- EU MDR Article 58
- EU IVDR Article 53
How to Transfer CE Certificate to Another Notified Body (Step-by-Step Process)
- Initiation: Contact the new Notified Body at least six months before expiry.
- Documentation: Provide previous audit reports, technical files, and records of non-conformities or corrective actions.
- Assessment: New Notified Body reviews documentation for MDR/IVDR & ISO 13485 compliance.
- Audit: Transfer audit may be conducted to ensure ongoing compliance.
- Certification: Successful assessment leads to CE certificate issuance, enabling uninterrupted market access.
If my certificate is withdrawn by a Notified Body, should I stop selling my products?
- Yes, immediately cease placing new products on the market.
- Products already placed before withdrawal may remain available if compliant and safe.
- Define a cut-off point to identify which Notified Body is responsible for which products during transfer.
Looking to transfer CE certificate to a new Notified Body seamlessly?
Role of Operon Strategist in Transfer CE Certificate to Another Notified Body
At Operon Strategist, we guide medical device manufacturers through every step of the CE certificate transfer process. From identifying a suitable Notified Body in the NANDO database to preparing technical documentation, managing audits, and ensuring compliance with EU MDR, IVDR, and ISO 13485, we provide expert support to make the transition seamless. Our experienced team ensures that your certificate transfer is efficient, compliant, and uninterrupted, allowing you to focus on delivering safe and effective medical devices across Europe.
FAQs
Can I transfer a CE certificate at any time?
Yes, but plan at least six months before expiry to allow proper assessment and avoid gaps.
Will a transfer audit cover the same scope as the renewal audit?
Usually, the transfer audit focuses on critical compliance areas, but some Notified Bodies may combine it with a renewal audit.
What if my Notified Body withdraws the certificate before the transfer is complete?
Stop placing new products immediately. The new Notified Body will take responsibility for products once the transfer is complete.
How do I find a suitable Notified Body for transfer?
Check the NANDO Database to identify Notified Bodies authorized for your device type.
