REGULATORY PERSPECTIVE OF MEDICAL DEVICE (2017 EU/MD) BY-ROHITINTRODUCTION © ‘medical device’ means any instrument, apparatus, appliance, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:- -Diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease, -Diagnosis, monitoring, treatment, alleviation of, an injury or disability, -Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state -Providing information by means of in vitro examination of specimens derived from the human body, including organ,blood and “@ donations.CLASSIFICATION RULES (EU/MDD 2017 ANNEx-VIII/CHAPTER 8) DURATION OF USE Transient continuous use for less than 60 minutes. Short term continuous use for between 60 minutes and 30 days. Long term continuous use for more than 30 days. Rules for non-invasive MD All non-invasive devices are classified as class I, except All non-invasive devices intended for channeling blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class lla. -Except for blood bags; blood bags are classified as class IIb. r )CONTINUE... All non-invasive devices for modifying the biological or chemical | composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class Ilb except those are for filtration and exchanges of gas, in which case they are classified as class Ila. Class lla if any device is principally intended to manage the microenvironment of wound. -Adhesives for topical use© All non-invasive devices which come into contact with injured skin or mucous membrane are Class | if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates. Class Ilb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent. -If nanoparticle or drug Class IIIRULES FOR INVASIVE MD +All invasive devices except surgically invasive device with respect to body orifices, other than surgically invasive devices - Class | if transient use. - Class Illa if they are intended for short-term and Ilb if long term use. + Surgically invasive devices- class Ila unless, -Control, diagnose, monitor or correct a defect of the heart through direct contact with those parts of the body, then they are classified as class Ill. -are reusable surgical instruments, in which case they are classified as class |o Administer medicinal products by means of a delivery system (Hazardous manner), Class Ib -have a biological effect or are wholly or mainly absorbed in that case they are classified as class lib © Implantable devices and long-term surgically invasive classified as class Ib but implanted at outer orifice of body Ex. Teeth implant-lia © Implantable devices or their accessories, in which cases they are classified as class Ill are breast implants. © All invasive devices with respect to body orifices, other than surgi invasive devices, which are intended to administer medicinal products inhalation are classified as class llaTHE MEDICAL DEVICE CLASSIFICATION (EU MOR 2017/745 ANNEX VIII) o Class |: Wheelchair, otoscope, stethoscope, scalpel, plaster. © Class | (Special): It can be the same products as listed on class | but with special aspect. ‘Meu » Measuring function-Thermometer « Delivered Sterile-Bed pans sl » Reprocessed to be reused -scalpel RIGH © Class Ila: Syringe which delivers a medicine, Teeth implant, X-Ray Device, Contact lenses. © Class IIb: Blood bag, implantable plate, screws and haemodialysis system © Class Ill: Drug coated stent, spinal disc cage, breast implants, pacemake Artificial valve, CNS chips. aREGULATORY PROCESS FOR MEDICAL DEVICES IN EUROPEAN UNION © Step1- Determine which EU Medical Device Directive applies to the device for certification: MDR [( 93/42/EEC — Medical Devices Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices Directive (AIMDD) or 79/98/EEC IVD)) © Step 2- Determine classification of device using Annex VIII of the Medical Devices Directive (MDD): Class | (non-sterile, non- measuring), Class | (Sterile, measuring), Class || a, Class || b or Class II/AIMD, Active implantable medical devices are typically subject to the same regulatory requirements as Class ||| devices. &© Step 3 - For all devices except Class |, implement Quality Management System (QMS) in accordance with Annex Il or V of the MDD. For Class |, a QMS is not formally required, though not likely to be audited by a Notified Body (NB).QMS The quality management system shall address at least the following aspects: A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system. Identification of applicable general safety and performance requirements Responsibility of the management; Resource management: including selection and control of suppliers and sub-contractors; Risk management as set out in in Section 3 of Annex |. Clinical evaluation in accordance with Article 61 and Annex XIV, including PMGF @ Product realization, including planning, design, development, productiol and service provision;© Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29; eo Implementation and maintenance of a post-market surveillance system, in accordance with Article 83 © Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders; © Processes for reporting of serious incidents and field safety corrective actions in the context of vigilance. © Management of corrective and preventive actions and processes for monitoring and measurement of output, data analysis and product improvement.NOTIFIED BODY (NB) Right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification. Carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and _ scientific competence in the specific fields(Annex IX and XI). The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens’ confidence in the system The technical documentation, in particular documentation on clinical evaluation, should be critically evaluated by the authority responsible for notified badies. For class III implantable devices and class Ib active devices intended to administer and/or remove a medicinal product, notified bodies should, in certain cases, be obliged to request expert panels to scrutinise clinical evaluation assessment report.© Step 4 - For Classes Il b, prepare a Technical File which provides detailed information on medical device, and demonstrates compliance with 93/42/EEC. For Class I\I/AIMD devices.TECHNICAL DOCUMENTATION Device description and specification- Product or trade name and a general description of the device including its intended purpose and intended users Reference to previous and similar generations of the device Labeling and the instructions for use in the languages accepted in the Member States Design and manufacturing information General safety and performance requirements- The method or methods used to demonstrate conformity with each applicable general safety and performance requirement, precise identity of the controlled documents offering evidence of conformity with each e@ harmonized standard,© Benefit-risk analysis and risk management (sections 1 and 8 of Annex I,) -the solutions adopted and the results of the risk management © Product verification and validation - Results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device © Pre-clinical and clinical data - Results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device - Detailed information regarding test design, complete test or study protocols, methods of data analysisBiocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user; - Physical, chemical and microbiological characterization © Stability, including shelf life © The clinical evaluation report and its updates and the clinical evaluation © Additional information required in specific cases - Where a device is manufactured utilizing tissues or cells of human or animal origin - In the case of devices that are composed of substances or combinations of substances (PK data for drug device)© Step 5 — Appoint an European Authorized Representative (EAR Rep) located in Europe. The AR Rep should be qualified to handle regulatory issuesAUTHORIZED REPRESENTATIVE Manufacturer of a device is not established in a Member State, manufacturer designates a sole authorized representative Task perform by AR are:- Confirm the appropriate conformity assessment procedure and immediately inform the manufacturer about complaints from physician Keep available a copy of the technical documentation Verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29 Forward to the manufacturer any request by a competent authority of the Member State Co-operate with the competent authorities on any preventive or cor action taken to eliminate or mitigate the risks posed by devices.© Step 6- For all devices except Class I, QMS and Technical File must be audited by a Notified Body. © Step 7 - For all devices except Class |, manufacturer will be issued a European CE Marking Certificate for device and an ISO 13485 certificate for facility following successful completion of Notified Body audit.CE (EUROPEAN CONFORMITY) MARKING C € © Devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V (Except custom made device and clinical use or Investigational device) © The CE marking shall be affixed visibly, legibly and indelibly to the device. IS A = Check which directives are applicable for device “Sy * Determine the class and choose conformity yy, assessment procedure + Prepare technical documentation, implement QMS * Prepare CER + Prepare declaration of conformity and submitted to Notified body for certification + Apply CE mark and market the product a + Implement post-market surveillance:Step 8 — Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. Step 9-All Class | devices must be registered with the Competent Authority. Step 10 — Must perform and PMS activities. For all other classes, manufacturer will be audited each year by a Notified Body to ensure on-going compliance with 93/42/EEC or 90/385/EEC. Failure to pass the audit will invalidate your CE Marking certificate. CER must perform updates and PMS activities.POST-MARKET SURVEILLANCE o Post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market ° Data gathered by the manufacturer's post-market surveillance:- -Information concerning serious incidents, including information field safety corrective actions. -Records referring to non-serious incidents and data on any undesirable side-effects and publicly available information about similar medical devices -Information from trend reporting -Information, including feedbacks and complaints, provided by users r ) distributors and importersMAJOR CHANGES Notified bodies (NB), manufacturers and importers will have to be registered (MDR certificate) Installation of a scrutiny procedure for NBs (Class Ilb and ||| devices) Technical documentation (Annex Il) must be updated continuously Labeling requirements (Sterile Barrier Labeling, Absorbable device, e IFU) Clinical investigation A Unique Device Identification (UDI) will be required The EUDAMED Database will be extended: -Access to competent authorities, manufacturers, Notified Bodies and the public and Display of certificates, vigilance reports, clinical investigations, and PMCFs(Post Market Clinical Follow up) . a itps:/oe. eU@pa.euinealth’md: euslamedioverview enCER CONTENT “Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference) “Section B: Reviewers involved in the notified body assessment of the clinical evaluation -Section C: Device description, +Section D: Clinical literature review Section E: Clinical investigations and related documentation “Section F: PMS, PMCF and the plan for updates. *Section G: IFU, SSCP, labelling and other information supplied with the device +Section H: Summary of all available data and conclusions a *Overall Conclusions‘TO (onez70n20051 7001 {eNOS NATH VNC Device dentiter . oe ye Nimber Nanber 4.EC International (Slovakia) — 2265 (MOR scope) 2.BS! (Netherlands) — 2797 (MOR scope 3.BSI (UK) — 0086 (DR scope) 4.CE Certiso (Hungary) — 2409 (MOR scope) 5.DARE!!! Services (Netherlands) — 1912 (MDR scope) 6.DEKRA Certification (Germany) — 0124 (MOR scope) 7.DEKRA Certification (Netherlands) — 0344 (MDR scope) rer Sie sh ealiedaealaes dae Scabcued astaGENERAL OBLIGATIONS OF MANUFACTURERS. Manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV Keep up to date technical documentation and copies. After compliance with the applicable requirements affix the CE marking of conformity in accordance with Article 20. keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the effective manner aCONTINUE. © Manufacturers of devices shall implement and keep up to date the post- market surveillance system in accordance with Article 83. © Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. © Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices‘Chapter B- General Safety and Peel Hot (Aaoes 1 MR 207/745) wetad od Cmte ‘Apo Hane, common SpetcationCERTIFICATES ISSUED BY A NOTIFIED BODY © Certificates shall be drawn up in one of the official languages of the Union. © The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system © certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class Ilb devicesCONTENT OF CERTIFICATE Name, address and identification number of the notified body; Name and address of the manufacture Unique number identifying the certificate, if already issued, the SRN of the manufacturer Date of issue and expiry | Reference to this Regulation and Annex in accordance with which the conformity assessment has been carried out. Conclusions of the notified body's Legally binding signature of the notified body e@ |THANK YOU...