The European Community has officially adopted several Directives and Regulations related to the registration of medical devices in Europe. Therefore, any company that intends to sell a product in any European Community country must comply with the relevant Regulation and affix the CE symbol to their product in accordance with the stipulated requirements. As of May 26, 2021, compliance with the Medical Device Regulation 2017/745, which came into effect on May 25, 2017, has become mandatory, replacing the Medical Device Directive and the Active Implantable Medical Device Directive, which are no longer valid options for obtaining CE marking. The In Vitro Diagnostic Regulation 2017/746, which also came into effect on May 25, 2017, will become mandatory on May 26, 2022.

The requirements for CE compliance can be broadly divided into two categories: Quality System Requirements and safety and reliability requirements. The former pertains to the manufacturer’s compliance with the development and manufacturing processes of the product, while the latter encompasses biocompatibility, software validation, electrical safety, electromagnetic compatibility (EMC), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.

To obtain CE marking and European Medical Device Registration, a company must comply with one or more of the following requirements, depending on the product classification and level of risk: establish and maintain a Medical Quality Management System (QMS), test the product to demonstrate compliance with applicable standards, prepare a Technical File/Design Dossier for each product family, contract a European Authorized Representative, contract a Notified Body to audit the QMS and Technical Files/Design Dossiers, and register the company and list the product with at least one European Competent Authority.

The classification of the product determines the specific requirements for the family of products, with different levels of risk pertaining to different product classes. The expertise required to navigate these regulations includes:

  • Regulatory Strategy for the transition of existing CE Marked Devices to comply with new EU MDR and IVDR Regulations
  • Product Classification and Registration services
  • Regulatory support for product development documents such as design history files

  • MDSAP Compliance and Certification
  • European Authorized Representative (EAR) services in compliance with EU MDR Regulations
  • Remediation and action plan for Brexit transition
  • UK Responsible Person
  • Comprehensive European Medical Device Regulation (EU-MDR) Compliance & Transition consulting
  • Gap Analysis of technical documents & quality systems
  • Regulatory support for Technical File Compilation [CE Technical File]
  • Regulatory and Market Intelligence support
  • Health Agency and Notified Body liaising and support
  • End-to-end project management for EU MDR, IVDR, and post-Brexit transition, and EUDAMED Compliance
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