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IVDR CE Marking Service in London
IVDR CE Marking Service provider in London: In the context of In-vitro Diagnostic Device CE marking as of my last update from UKMHRA authorities, the UK has implemented its own conformity marking known as the UKCA (UK Conformity Assessment) marking. This UKCA marking is intended to replace the CE marking in most cases for products sold in Great Britain (England, Wales, and Scotland). However, CE marking may still be required for products intended for sale in Northern Ireland or for products subject to specific regulations.
It’s essential for manufacturers selling medical devices, medical equipment, medical consumables, single-use devices, and medical software products in the United Kingdom to ensure compliance with the relevant EU regulations. This process may entail securing CE Certification from EU-notified bodies, which typically requires collaboration with regulatory authorities and may involve interactions with third-party conformity assessment entities.
For the most accurate and up-to-date information regarding IVDR CE Marking and other regulatory requirements in London, UK manufacturers and exporters may consult with experts specialising in in-vitro diagnostic device regulatory and product compliance.
IVDR CE Marking - Role of Consultants
We are regulatory consultants play a crucial role in the IVDR CE Marking process and certification.
- MDQMS – EN ISO 13485:2016/ BS ISO 13485:2016 implementation support
- ISO 14971 Risk Analysis Implementation and documentation
- Biological Evaluation plan and reporting
- Clinical and Performance Evaluation Guidance and docuemntation.
- Usability Studies related to IVD equipments and tests kits
- Process Validations
- IVDR Techncial Documentation File
- Interaction with IVDR Notified Bodies
Outsource IVDR Regulatory to I3CGlobal
Outsourcing IVDR regulatory services for CE Marking offers several benefits to IVD manufactures in London and other parts of United Kingdom:
- I3CGlobal team of IVDR expertise help manufactures avoid technical mistakes and thereby reduce the delay in IVDR certification process.
- Our teams extensive knowledge and experience in IVD regulations ensure compliance much faster
- Outsourcing regulatory services offers cost savings over hiring in-house experts, reducing overhead
- Companies can focus on core activities while experts handle MDR compliance, speeding up product launches
- Consultants maintain and update documentation.
- I3CGlobal networks with regulatory authorities and Performance testing labs streamline interactions, expediting approvals.
Outsourcing IVDR regulatory services for invites diagnostic devices boosts efficiency, cuts costs, and lowers risks. It speeds market access, aiding product success and business growth.
Frequently Asked Questions
IVDR CE Marking Timeline
♥ Class C & D devices typically require 4 to 5 months of extensive performance evaluation and documentation, leading to a longer certification process
♥ Class B, C & D the involvement of a Notified Body is mandatory, so the timeline of TF assessments, conducting audits, and awaiting feedback will take around 6 to 8 months.
IVDR CE Certification takes around twelve months based on product features. Experienced regulatory consultants like I3CGlobal can optimise timelines and ensure compliance, facilitating a smoother IVDR certification journey.
What is the process of IVDR Technical documentation and file preparation?
Indeed, manufacturers are required to provide all technical and production-related data to consultants for the compilation of IVDR technical documentation. This documentation includes comprehensive details about the design, manufacturing, and performance of the IVD device. It includes specifications, drawings, risk assessments, performance evaluation reports, test reports, and other pertinent documentation. This collaborative approach ensures that the IVDR technical documentation meets regulatory requirements and supports successful certification. Sharing documents through cloud platforms facilitates transparency and real-time collaboration among stakeholders, streamlining the process.