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CE Marking Services
The healthcare landscape in the European Union (EU) is changing, with substantial advances in medical technology resulting in more tailored and effective treatment alternatives.
CE Marking Services Overview
In the European Union (EU), medical device manufacturers must comply with the strict requirements of the EU Medical Device Regulation (EU MDR) 2017/745 and obtain CE certification to access the market. Pharma Wizard offers specialized expertise to help manufacturers navigate the complex compliance process, ensuring efficient and successful CE marking.
To date, Pharma Wizard has assisted in the preparation and submission of more than 50+ CE files for medical devices.
Process for CE Marking Registration for Medical Device
- Identify and classify the medical device under EU MDR/IVDR according to Annex VIII and determine if an audit by Notified Body (NB) is required based on the classification.
- Establish a Quality Management System (QMS) for the device as per ISO 13485:2016.
- Plan and conduct device-specific studies for necessary data generation.
- Compile a technical file as per EU MDR 2017/745 or EU IVDR 2017/746.
- Submit the technical file and device for an audit by NB.
- After passing the NB Audit, prepare a Declaration of Conformity (DoC) asserting compliance with EU IVDR/MDR.
- Once the device is CE marked, the manufacturer may have to provide all the documentation supporting CE mark to the Authorized Representative, distributors, or importers, as well as the competent authority if requested.
- Post-market Surveillance (PMS) plan development services for both medical devices and In Vitro Diagnostic (IVD) devices.
How Prepared Are You for the CE Certification?
Placing a medical device in the EU region can be daunting because of multiple regulatory hurdles for obtaining a CE marking certification. Pharma Wizard can support you in making your journey towards medical device CE certification smoother with our regulatory experts.
CE marking guide:
Reach out to us Today at info@phrxwiz.com
Medical Device Regulatory Services in Europe
- Expertise
- Advantages
- Pharma Wizard offers a one-stop-shop solution for all your CE marking services requirements for placing your medical device in Europe.
- Our expertise includes:
- Regulatory Strategy and Classification:
- Expert identification and classification of your medical device.
- Determine the need for NB audits based on device classification.
- Quality Management System (QMS):
- Establishment and implementation of a robust QMS in accordance with ISO 13485:2016.
- Clinical and Performance Data:
- Planning and execution of medical device-related studies to generate essential clinical and performance data.
- Data analysis and documentation to support regulatory submissions.
- Technical File Compilation:
- Preparation of a comprehensive technical file as per EU MDR 2017/745 or EU IVDR 2017/746.
- Notified Body (NB) Coordination:
- Submission of the technical file and coordination with the NB for device audits and addressing any queries and issues throughout the audit process.
- Declaration of Conformity (DoC):
- Preparation of the DoC, asserting compliance with EU MDR/EU IVDR after passing the NB audit with support in maintaining compliance post-certification.
- Successful submissions for a varied class of devices ranging from simple Class I devices to complex devices such as Class III devices, Implants, SaMDs.
- Local affiliate access to meet challenges of authority and language specific requirements
- Dedicated Medical Writing team for CE projects
- Dedicated personnel to provide Medical Device and IVD Regulatory support
- In-country or legal representative support with a cost-effective model