CE MDR | Medical Device

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  What is CE Marking ?

  The medical Device Regulation is intended to harmonize the legislation on medical devices within the European Union. Legally, in order to sell Medical devices to the European Market, manufacturers must comply with the requirements of the Medical Device Regulation(MDR) after enforcement in 2020. The applicant’s product and quality system must be evaluated, and the manufacturer must affix the CE mark before selling the products.

  • Applicable standards : Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Ap
  • Legal content : Council Directive 93/42/EEC (MDD) + Council Directive 90/385/EEC (AIMD)
  • Effective Date : May 25, 2017
  • Compulsory application date : May 26, 2020, after the MDR takes effect a grace period of 3 years
  • Purpose : To create a safer, more effective and innovative medical device market in Europe.
  • MDD certificate final validity date: May 26, 2024 (sale until May 27, 2025)
  • Changed from Directive to Regulation. Regulation change more frequently than Directives and are more enforceable.

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  Major Revision Contents

  • Strong control of health authorities over the Notified Body(NB): Reinforcement of sub-contractor management
  • Introduction and application Common Specification for each product in addition to the harmonized standard.
  • Strengthening the responsibility of economic operators [Manufacturer, Importer, Distributor, Authorized Representative]
  • Strengthening the responsibility of economic operators (Manufacturer, Importer, Distributor, Authorized Representative)
  • NB’s strong control over manufacturers
  • Expansion of clinical evaluation of Pre/Post Market and management of all clinical investigations, and reinforcement of market surveillance (Vigilance & PMS) after marketing by manufacturers
  • Establishment of computer system based on EUDAMED(European database on medical devices): product registration, UDI, economic operator registration, NB and certificate, clinical research, Vigilance & PMS, market research (health authorities)
  • Improvement and introduction of UDI System : sequential introduction from Class III. Currently it’s compatible with FDD, subject to change.
  • MDCG(Medical Device Coordination Group) : A medical device coordination group composed of independent expert within the health authority. Evaluate NB, Manage Class III, Consult clinical evaluation and investigate conformity assessment in detail for Class III implantable & Class IIb active device product.
  • Class I reusable surgical instrument : Like Class I sterilization/measuring devices, subject to NB review → only for reprocessing processes such as washing/cleaning process
  • Implant Card : Doctor, manufacturer, patient, serial number, etc.
  • Person Responsible for Regulatory Compliance) : A person who has more than one year of quality & RA work experience, and four-year college degree or higher, responsible for the release of technical documents and products.
  • Application of MDR to products that do not belong to the definition of medical devices → Fillers, ties, and laser surgery devices(hair removal, cosmetic purposes)

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  Content to be included in the TCF(Technical Document)

  • 1. Completion of GSPR(General Safety and Performance Requirements) Check List of MDR Annex 1
  • 2. Biological Safety Assessment Report (ISO10993-1:2018)
  • 3. Risk Management Plan (ISO14971:2019)
  • 4. Risk Management Report
  • 5. Usability Validation Plan (IEC62366-1:2015)
  • 6. Usability Validation Report
  • 7. Clinical Evaluation Plan (MEDDEV 2.7/1 :2016
  • 8. Clinical Literature Search Protocol
  • 9. Clinical Literature Search Report
  • 10. Adverse Event Search Report
  • 11. Clinical Evaluation Report
  • 12. Prepare Process (Sterilization, Cleaning, Packaging, Clean Room) Validation Report
  • 13. Software Validation Plan
  • 14. Software Validation Report
  • 15. Product drawing and schematic drawing
  • 16. Manufacturing flow chart
  • 17. User Manual (Instructions for use)
  • 18. List of used materials(important components), etc./li>
  • 19. Product Label
  • 20. Annual upload of SSCP(Summary of safety and clinical performance) : Implantable and Class III Article 32
  • 21. Regularly update PSUR(Periodic Safety Update Report) : Class IIa, IIb, III product Article 86
  • 22. DOC (Declaration of Conformity)

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  IGC’s Competency

  IGC is contributing to the continuous development of customers by accurately evaluating the suitability of product certifications through the technology and expertise accumulated over the years.
  
  IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world and provides the knowledge and services to support your entire global operation.
  
  In addition, IGC provides various certification related services in the medical device field.

  • Regulation (EU) 2017/745 on medical devices
  • ISO 13485