IVDR CE Marking
Service in London

Welcome to Cert3global, we are providing expert-oriented services to fulfill your IVDR CE Marking needs. Read below the necessary compliance and factors for a successful marking journey.

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IVDR CE Marking Service provider in London:
  •  In the context of Medical Device CE marking, the UK MHRA (Medicines and Healthcare products Regulatory Agency) has implemented its 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).
  • Nonetheless, CE marking might remain necessary for products designated for sale in Northern Ireland or those subject to particular regulations.
Key Considerations for Manufacturers:
  • Manufacturers selling medical devices, medical equipment, medical consumables, single-use devices, and medical software products in the United Kingdom must ensure compliance with relevant EU regulations.
  • This may include obtaining CE Certification from EU-notified bodies.
  • Compliance typically includes cooperation with the regulatory authorities and potentially enlisting the services of third-party assessment bodies.
Consulting Experts for Regulatory Guidance: For the most accurate and up-to-date information regarding CE Marking and other regulatory requirements in London, UK manufacturers and exporters may consult with experts specializing in medical 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 
  • Usability Studies related to IVD equipments and tests kits
  • Process Validations
  • IVDR Technical Documentation
  • Interaction with Notified Bodies

Partner with CERT-3 Global for Regulatory Outsourcing

Outsourcing regulatory services for medical devices offers several benefits to manufacturers operating in London and parts of the United Kingdom.

Expert Guidance: Regulatory consulting firms such as CERT3 GLOBAL navigate complex regulatory landscapes, bringing extensive knowledge and experience in dealing with regulatory agencies, interpreting regulations, and ensuring compliance. This expertise can help manufacturers avoid mistakes and expedite the CE Mark certification process.

Cost Effectiveness: Hiring outside help for regulatory services can save money compared to training and employing in-house experts. By outsourcing regulatory activities to service providers like CERT3 GLOBAL, manufacturers can reduce the overhead costs associated with maintaining a full-time regulatory team.

– Streamlined Documentation: Outsourced companies take care of and update documentation consistently, ensuring compliance at all times.  

– Focus on Core Activities:   Outsourcing regulatory services allows companies to focus on their core business activities while regulatory experts handle the complexities of MDR compliance. This can accelerate time-to-market for new products and reduce delays in regulatory approvals.  

-Established Networks:   Regulatory consulting firms often have established networks and relationships with regulatory authorities, testing laboratories, and other key stakeholders. This access can facilitate smoother interactions with regulatory agencies and expedite the regulatory process.  

– Overall Benefits: Outsourcing regulatory services for medical devices can help companies navigate the complex regulatory landscape more efficiently, reduce costs, mitigate risks, and accelerate market access, ultimately contributing to the success of their products and business ventures.