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EU Medical Device Classification
Before medical device manufacturers can legally CE mark their products in Europe, they must comply with the current medical device directive set forth by the EU Commission. It is critically important to know the correct medical device classification for your product before attempting to obtain a CE mark for your device. Different classifications effect the regulatory requirements for your device, as well as the approval process and associated costs.
Determining Your Device Classification for Europe
The first step in the European regulatory process is determining which directive applies to your product. Most devices fall under the Medical Devices Directive (MDD) 93/42/EEC but some high risk implantable products must follow the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. The In Vitro Diagnostic Directive (IVDD) 98/79/EC applies to IVDs.
Europe uses a rule-based classification scheme for medical devices under the scope of the MDD. Those 18 rules can be found in Annex IX of the MDD. The European system stands in contrast to the US system which depends on finding similar devices (predicates) already approved by the FDA.
How Medical Devices are Segmented in Europe
Essentially, all devices fall into four basic categories:
- Non-invasive devices
- Invasive medical devices
- Active medical devices
- Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical devices)
Devices are further segmented into the classes noted below. IVDs have their own classification scheme and while active implantable devices do not follow the same classification system as provided by the MDD, they are subject to similar requirements as Class III devices:
- Class I – Provided non-sterile or do not have a measuring function (low risk)
- Class I – Provided sterile and/or have a measuring function (low/medium risk)
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
How we can help:
Our team specializes in medical device regulatory compliance and can help you determine the proper classification for your medical device or IVD. Our in-depth knowledge of European medical device regulations ensures that we can assist you in finding the most efficient regulatory approval strategy for your device. We can assist you preparing a Technical File or a Design Dossier that demonstrates compliance with the MDD, IVDD or AIMDD.
MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices
If you currently sell or plan to sell your medical devices in Europe, you must maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Your CER documents the result of the clinical evaluation of your device. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.
Clinical evaluation reports are an important step in the process of CE Marking. Many manufacturers struggle to comply with the changing European CER requirements – but Nerac has vast experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER.
Preparing a Clinical Evaluation Report (CER) for medical devices
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, it is best to approach the CER as a standalone document.
When to update your device CER
The initial report is just the beginning of the CER’s lifespan. You must update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:
- Each year (annually), unless…
- You receive new information from post-market surveillance that might change the current evaluation, or…
- Every 2-5 years if the device is not expected to carry significant risk and is well established in the market.
We can assist with your Clinical Evaluation Reports and literature reviews
Nerac specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory professionals brings a depth of experience with a wide range of medical devices and IVDs.
How we can help:
- Gather and analyze appropriate scientific literature applicable to your device
- Compile and draft the CER in compliance with EU requirements
- Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER
- Develop a protocol to methodologically search and evaluate journal articles and provide a synopsis
CE Technical File or Design Dossier Compilation and Review
A Technical File or Design Dossier (Class III) for a CE Mark is a comprehensive description of your device which is intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in the European CE Mark process and a requirement for compliance with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
Europe’s new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for medical devices and IVDs. Nerac is equipped to assist with the MDR/IVDR transition to the new requirements.
CE Technical File and Design Dossier Requirements
The technical file or dossier includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. Technical Files are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb and III) but no two files are the same because the type of device dictates the information included within.
Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is critical for approval.
Nerac offers CE Technical File and Design Dossier compilation services to help medical device and IVD companies achieve CE Mark certification.
How we can help:
- Determine exactly which materials need to be compiled
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
- Evaluate and identify gaps or deficiencies in your documentation
- Compile your EU Technical File or Design Dossier, with internal peer review
- Determine applicable testing requirements and standards for your device
- Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary
- Review your proposed labeling and Instructions for Use