CE marking requirements

We provide consulting services related to identifying differences between Japanese and European regulations to enable our clients to obtain CE marking. As part of these services, we:

• Investigate the requirements (identify design inputs, including harmonized standards)
• Analyze the client’s product to determine whether it complies with the requirements for CE marking
• Hold lectures on the requirements
  • Compliance with CE marking requirements
  • Design development (essential requirements, product classification, applicable standards, etc.)
  • Clinical evaluations
  • Post-marketing surveillance (PMS)
  • Software lifecycle processes (EN 62304)
  • Usability engineering (EN 62366)
  • Risk management (EN 14971)
  • Labeling (EN ISO 15223-1, EN 1041 etc.)
  • Vigilance system
  • Sterilization validation and sterile barrier system (related to transport simulation testing in accordance with ISO 4180, etc.)
• Provide and customize samples of the following procedure manuals
  • Procedure manuals related to CE marking
  • Documents related to clinical evaluations:
    • Clinical evaluation plans, clinical evaluation reports, literature search protocols, literature search reports, etc.
  • Assessment reports on non-compliance with EU risk management requirements
  • Procedure manuals for preparing technical documents
  • Samples of Part A of technical files and compliance statements (templates)
  • Vigilance procedures and forms that comply with European standards
  • Usability engineering procedure manuals and forms:
    • Specifications, verification plans, verification reports, validation plans, and validation reports
  • Software lifecycle process procedure manuals and forms:
    • Safety classification reports, development plans, requirement definitions, architecture specifications, testing protocols, and testing reports

Transition to the Medical Devices Regulation (MDR)

We provide consulting services related to transitioning from the EU’s Medical Device Directive (MDD) to its Medical Devices Regulation (MDR). As part of these services, we:

• Hold on-site seminars related to MDR requirements
• Analyze the client’s product to determine whether it complies with CE marking requirements (provision of information about differences between the MDD and the MDR)
• Work with the client to examine action plan drafts and related documents, including documentation related to the following:
  • General Safety and Performance Requirements (GSPR)
  • Procedural steps for ensuring compliance with CE marking
  • Quality manuals
  • Technical files
  • Post-marketing surveillance (PMS) reports and periodic safety update reports (PSUR)
  • Labeling
  • Contracts and agreements
• Provide related sample documents and review documents prepared by the client

Clinical evaluations

We provide a range of services related to the conducting of clinical evaluations, from devising clinical evaluation strategies and conducting academic paper research to drafting clinical evaluation reports. In providing these services, we carry out the following steps:

• Creating a new clinical evaluation plan (in compliance with MEDDEV 2.7/1 Rev.4)

  Step 1: Analyze the product’s future prospects and assess the evaluation methods

  • Hold lectures on the requirements for MEDDEV 2.7/1 Rev. 4
  • Check the current risk management, non-clinical evaluations, and related documentation
  • Investigate equivalent products and verify their equivalence
  • Conduct a preliminary literature investigation to identify core clinical data
  • Draft a plan, if feasible, based on the above activities

  Step 2: Draft documents related to the clinical evaluation

  • Draft the literature search protocol
  • Draft the literature search report
  • Conduct academic paper research
  • Draft the clinical evaluation report (in compliance with MEDDEV 2.7/1 Rev. 4)
    * SunFlare sells a sample Japanese translation of MEDDEV 2.7/1 Rev. 4.
  • Have the clinical evaluation report translated by specialists
  • Provide advice on responding to inquiries from the notified body
• Updating from Rev. 3
  • Hold lectures on the requirements for MEDDEV 2.7/1 Rev. 4
  • Check the current clinical evaluation report and related documents
  • Provide the following sample documents (in compliance with MEDDEV 2.7/1 Rev. 4):
  • 　　Clinical evaluation report, declaration of interests form, assessment form for determining the necessity of a post-market clinical follow-up (PMCF), and clinical evaluation planning form
  • Assist in adapting the content of the client’s existing clinical evaluation report to the format required under MEDDEV 2.7/1 Rev. 4, summarize missing items, etc.
  • Provide feedback and advice on items that need to be corrected or added
  • Provide advice on responding to inquiries from the notified body

Past projects

Over the past 8 years, we have carried out 179 projects related to supporting the preparation of clinical evaluation reports that comply with MEDDEV 2.7/1 Rev. 4 and MDCG guidances.

Main target products
Diagnostic imaging devices, rehabilitation devices, nursing-care devices, hemodialysis units, catheters, stent grafts, dental materials, dental devices, hemostats, synthetic bone, suture thread and other new medical devices

Technical files and design dossiers

We provide services related to the drafting of technical files and design dossiers. As part of these services, we:

• Draft the technical file and design dossier
• Have the technical file and design dossier translated by specialists
• Support audits conducted by the notified body

EN ISO 13485-compliant QMS

We assist in establishing a quality management system (QMS) that complies with the European Standard EN ISO 13485. As part of this assistance, we:

• Analyze the client’s existing QMS to determine whether it complies with the requirements of EN ISO 13485
• Provide and customize samples of procedure manuals and forms related to acquiring CE marking, conducting clinical evaluations, preparing technical documents, and ensuring vigilance compliance with European standards

Selection of a European Authorized Representative

We assist in selecting a European Authorized Representative. As part of this assistance, we:

• Provide a list of European Authorized Representatives and assist in making an appropriate choice

Post-marketing safety management activities

We assist in conducting post-marketing safety management activities. As part of this assistance, we:

• Establish a vigilance system that complies with European standards
• Collect information on malfunctions of the client’s product or similar products in European countries
• Provide advice on conducting post-marketing surveillance (PMS)

Benefits of CE marking in ASEAN countries

In some ASEAN countries, obtaining CE marking for a product can simplify the examination process and provide a partial exemption for the document submission requirements. Therefore, obtaining CE marking facilitates access not only to the EU but also to the ASEAN market.

Medical Device Regulation (MDR)

Drafted by the European Commission in 2012, the Medical Device Regulation (MDR) was adopted on April 5, 2017, to replace the Medical Device Directive (MDD) as the EU’s regulatory framework for medical devices. This regulation was officially enacted on May 26, 2017. For details,please see the MEDTEC WEB website (in Japanese).
SunFlare’s monthly e-mail magazine on medical devices also provides information on the latest trends related to the MDR, other laws and regulations in various countries, and revisions to standards. This e-mail magazine is available only in Japanese.
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