CE Marking
Launching a new IVD in Europe? Or transitioning a legacy device from IVDD to IVDR? Our global team of expert regulatory consultants offer a comprehensive range of flexible options to support your CE Marking needs.
Access the EU market with confidence and compliance
Work with a partner you can trust
At Apotech, our team can help you navigate the intricacies of regulatory frameworks to streamline the CE Marking process. From providing comprehensive assessments to offering strategic guidance, we can help you bring your innovative healthcare solutions to market with confidence and compliance.
Device classification
A crucial initial phase in any IVD registration project involves confirming the accurate classification of the device. This classification is a vital step in the regulatory pathway, as it dictates the regulatory requirements that a device must undergo to achieve market approval.
At Apotech, we’re experts in assisting manufacturers with device classification, to help identify the most appropriate regulatory pathway.
Classification is mainly driven by your IVDs ‘intended use’, so we will work with you to ensure its design fits your proposed purpose.
Notified Body selection and relationship management
Notified Bodies (NBs) are independent organisations designated by EU member states that play a crucial role in the regulatory framework for IVDs within the European Union. Their primary function is to assess and certify the conformity of IVDs with the essential requirements set out in the IVDD and IVDR prior to placing a device on the EU market.
Our team can work with you to find a Notified Body that aligns with the classification and characteristics of your devices. This will help ensure a smooth conformity assessment process and guaranteed compliance throughout your device's lifecycle.
Gap assessment
Understanding your current level of compliance is a vital step to assessing your readiness for entering the EU market – whether it be for the first time or transitioning. Our consultants will undertake a systematic assessment to identify and address discrepancies or ‘gaps’ between the current state of your device's regulatory compliance and the requirements set by these European regulations.
This includes determining your current level of compliance with the following:
- General Safety and Performance Requirements (GSPRs)
- Technical Files
- Performance Evaluations (PERs)
- Risk management
- Post Market Surveillance (PMS), including Adverse Event Reporting (AERs)
- Labelling and UDI
- Notified Bodies
Technical documentation compilation (including CER and risk assessment)
A Technical File is a comprehensive document required for all IVDs in the European Union. It serves as a key component in demonstrating conformity with the essential requirements outlined in the IVDR and usually must be reviewed by a Notified Body.
At Apotech, we can help you develop and optimise your Technical Files in a way that addresses the complexities of regulatory requirements. Our expertise helps ensure that your technical files are not only comprehensive and accurate but also regulatorily aligned with:
- GSPR requirements
- Marketing and labelling regulations
- Risk Management Report (in accordance with ISO 14971:2019)
- Performance Evaluation (PEP, PER and Literature Review)
- Periodic Safety Update Reports, PMCF plans and reports
- Summary of safety and clinical performance
- Notified Bodies
Learn more about our PER process
What is CE Marking?
Before launching a new IVD in the European market, you must ensure it complies with all relevant European Union (EU) safety, health and environmental regulations.
CE Marking is a certification that proves this, demonstrating a device’s compliance with the EU IVDD/IVDR. By having this certificate, you can then legally market and sell devices within the European Economic Area (EEA).