Market Access and Regulatory Solutions

For Medical Devices and In-Vitro Diagnostics

Regulatory Affairs & International Market Access

Regulatory requirements and documentation supporting medical devices and IVDs from classification and conformity assessment through market entry and post-market obligations.

Quality Systems & Standards Implementation

Development, implementation and maintenance of quality management systems, with applicable ISO, IEC and EN standards integrated into organisational and product processes.

Training & Knowledge Development

Regulatory and quality Management training for medical device and IVD organizations, covering applicable requirements, standards and their practical implementation within organizational processes.

EU & Swiss Authorised Representative

Authorised representative in the EU and Switzerland, including applicable regulatory and competent-authority communication responsibilities.

Frequently Asked Questions

QMS & Technical Documentation

  • QMS development establishes the documented framework, including procedures, processes, work instructions, forms and controls. QMS implementation means applying these established processes within the organization and maintaining the corresponding records to demonstrate that the system is effectively implemented.

  • ELLECOM supports the development, implementation and maintenance of Quality Management Systems aligned with ISO 13485 and applicable regulatory requirements. Support may include QMS documentation, procedures, work instructions, forms, process controls, implementation guidance and internal audits.

  • Yes. ELLECOM can review existing QMS and Technical Documentation to identify gaps against the applicable regulatory and standards requirements. Based on the assessment, existing documentation can be revised, supplemented or restructured where necessary.

  • A documented QMS must also be effectively implemented within the organization. Processes should be operational, required records should be maintained, and internal audits and management reviews should be performed so that implementation and effectiveness can be demonstrated during an assessment.

  • The QMS defines and controls regulatory processes, while the Technical Documentation contains the device-specific documentation resulting from and governed by those processes. Areas such as design and development, risk management, verification and validation, clinical evaluation and post-market activities therefore require appropriate alignment between the QMS and Technical Documentation.

  • No. ISO 13485 certification applies to an organization’s Quality Management System, not to an individual medical device. Device conformity is demonstrated separately through the applicable regulatory conformity assessment, supported by Technical Documentation demonstrating compliance with the relevant safety, performance and regulatory requirements.

  • Yes. ELLECOM can provide regulatory support during the assessment process, including clarification of QMS and Technical Documentation requirements and support in addressing questions, findings or non-conformities relating to procedures, plans, reports and regulatory documentation.

  • The applicable conformity assessment requirements must be successfully completed. Depending on the conformity assessment route, this may include assessment of the organization and review of the Technical Documentation for representative devices within the certification scope. The Technical Documentation must demonstrate conformity with the applicable requirements of Regulation (EU) 2017/745.

  • No. The scope of certification is defined, and the certificate applies to the devices included within that approved scope and corresponding product listing. New devices or device groups may require an application to extend or amend the existing certification scope.

  • The intended purpose is fundamental to determining whether a product qualifies as a medical device and influences several subsequent regulatory decisions, including classification and the applicable conformity requirements.

    The intended purpose should clearly describe the medical purpose of the device rather than relying only on its product name or general description.

  • Classification should be based on the relevant characteristics of the device and the applicable classification rules. A classification rationale should explain which device characteristics influence classification and identify the applicable rules and sub-rules.

    Classification should therefore be supported by a documented regulatory rationale rather than simply assigning a class based on another similar product.

  • The Basic UDI-DI is the primary identifier of a device model or device family at the regulatory documentation level. It is used to group devices sharing relevant characteristics and is referenced in regulatory documentation and certification activities.

    The UDI-DI identifies a specific device configuration or packaging level within the UDI system. The two identifiers therefore serve different regulatory purposes and should not be confused.

  • These codes support regulatory identification, technical competence allocation and assessment planning.

    The EMDN code provides European Medical Device Nomenclature for the device. MDA/MDN codes identify medical device categories, while MDS and MDT codes provide additional information concerning specific device characteristics, manufacturing processes or technologies relevant to conformity assessment.

    They should be selected based on the actual characteristics and manufacturing technologies of the device rather than simply copied from a similar product.

  • Yes. Changes that may affect conformity with the MDR or the conditions under which the device is used should be evaluated before implementation. Depending on the nature of the change, communication with the Notified Body and further assessment may be necessary.