CE Marking for Medical devices

Transcription

1 CE Marking of Medical Devices Bart Mersseman Head of Notified Body SGS Belgium Thursday Octobere 12 th 2017 Vlaamse dag van de CE-markering CE Marking for Medical devices Prologue: Legislation in Europe and some definitions GET YOUR MEDICAL DEVICES TO MARKET FASTER WHEN YOU KNOW THE WAY 2 Current legislation in Europe Until 2012: slow evolution AIMDD: Directive 90/385/EEC covering active implantable medical devices MDD: Directive 93/42/EEC covering medical devices IVDD: Directive 98/79/EC covering in vitro diagnostic medical devices Directive 2000/70/EC covering medical devices incorporating stable derivates of human blood or human plasma Directive 2003/12/EC on the reclassification of breast implants Directive 2003/32/EC covering medical devices utilizing tissues of animal origin All directives are transposed into Belgian law (idem in the Netherlands) 21 March 2010: Directive 2007/47/EC: these amendment of MDD 93/42/EEC came into force 3 1

2 Recent changes in Europe Since 2012 (after PIP Breast implant scandal) : revolution? New European regulations/directives: COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) Was immediately applicable (25 September 2013) Major changes and major consequences: significant changes e.g. unannounced visits 4 Recent changes in Europe What will the future bring us: 25 May 2016!: EU agreed new Regulations on medical devices and in vitro diagnostic medical devices Still to be voted in the European Parliament, but the text is decided making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner. by strengthening the rules on placing devices on the market and tightening surveillance once they are available. 5 Basic definitions medical device Medical accessories 6 2

3 Definitions: Medical Device What is a Medical Device Medisch Hulpmiddel Dispositif Médical? According to Medical Device Directive (MDD) articel1 instrument, apparatus, appliance, software, material or other article used in human beings intended by the manufacturer to be used (intended use beoogde gebruik - utilisation prévue) diagnosis, prevention, monitoring, treatment or alleviation of disease thermometer, arterial stent, heating patch (rheuma), radiology device diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap Plaster, wound care gel, wheel chair, hearing aid, glasses, lenses investigation, replacement or modification of the anatomy or of a physiological process Breast implant, artificial kidney (dialysis), knee implant, teeth implant control of conception, condoom, intra uterine device (IUD) 7 Time for a little exercise Is this a medical device? 8 Definitions: Medical Device What is a Medical Device Medisch Hulpmiddel Dispositif Médical? Excluded from the MDD: principal intended action in or on the human body pharmacological : pharmaceutical product, even in combination with a MD Nicotine plaster, plaster with hormones immunological : even in combination with a MD Vaccination syringe, allergy tests (on patient) metabolic : even in combination with a MD Insulin syringe Also excluded from MDD, but are medical devices: In vitro diagnostic devices=>directive IVDD: medical blood analyzers, POCT devices Active implantable devices=>directive AIMDD Pacemaker, ear implant Borderlines: breast pump, electronic cigarette, syringe, 9 3

4 Definitions: Medical Accessory What is an Accessory Hulpstuk Accessoire? not being a (medical) device specifically intended to be used together with a device classified in their own right separately from the device with which they are used Accessories shall be treated as medical devices in their own right (for the purposes of the MDD) Examples: Spectacle-case Gel for ultrasonography Mount piece for spirometer 10 Definitions: CE marking When is CE marking required? All medical devices and accessories if: Class I (low risk) and not sterile nor a measuring function: CE without number of a Notified Body Wheel chair, normal hospital bed, All other: CE with number (and certificate) of a Notified Body Measuring spoon for medication (e.g. couch syrop), physiotherapy device, sterile dressing, wound contact gel, Except. 11 Definitions: CE marking When is no CE marking allowed? No CE marking allowed Custom-made device: Systems and procedure packs (containing only devices bearing the CE Marking) Devices intended for clinical investigation (pre-market): 12 4

5 Classification (annex IX) principles definitions Classification rules 13 Classification: principles Classification: the most rigorous conformity assessment procedure for all medical devices? graduated system of control is more appropriate apply an appropriate conformity assessment procedure. Risk based system Vulnerability: a risk based system based on the vulnerability of the human body intended purpose: Each device is evaluated based on the intended purpose (see technical documentation, but also labelling or IFU ) 14 Classification rules There are 4 classes identified (risk for patient/user): Class I devices: Low risk devices Class I sterile Class I measuring function Class IIa devices: Medium low risk devices Class IIb devices: Medium high risk devices Class III devices: High risk devices We had never an incident with our arterial stent, so this is not a high risk device Yes, it is just a bed, very low risk. The heating blanket is to keep the patient somewhat warm after surgery.??? 15 5

6 Classification rules Intended use : NOT the particular technical characteristics of the device NOT the accidental use of the device NOT the class assigned to other similar products Our competitor placed the CE mark without number of a Notified Body, so this is clearly classified as class I device. 16 Classification rules: criteria/features Criteria/features: Active: electrical energy or any source of power Invasiveness: body orifice, surgical invasive, implantable Duration of contact: transient, short term, long term, continuous use (uninterrupted use) But also: Reusable instrument Therapeutical use Diagnostical use Local or systemic use (anatomical location) central circulatory system central nervous system 17 Classification rules There are 18 rules in 4 groups: 4 non invasive devices (rules 1 to 4) 4 invasive devices (rules 5 to 8) 4 active devices (rules 9 to 12) 6 special rules (rules 13 to 18) consideration all the rules in order to establish the proper classification for its device.. More than 1 rule applicable: highest classification is applicable: e.g. wound dressing containing silver Details on the device classifications can be found in the MEDDEV guideline 2.4/1 Rev. 9 June

7 Classification rules (see also MedDevMEDDEV 2. 4/1 Rev. 9) 19 The certification process 1. Contact with Notified Bodies 2. Conformity assessment procedure 3. Technical documentation 4. Medical quality system (role of EN ISO 13485) 20 CE Marking for Medical devices Part 1: Contact with Notified Bodies GET YOUR MEDICAL DEVICES TO MARKET FASTER WHEN YOU KNOW THE WAY 21 7

8 CE-Marking: Notified Body 1 As early as possible: check applicable directives and standards, check definitions 2 During development stage: contact your Notified Body 3 During development stage: start compiling technical documentation 4 Write your quality (system) manual (procedures, work instructions, registration forms) 5 Implement your quality system and finish technical documentation 6 Review of the technical documentation and certification audit by your Notified Body 7 Affix CE marking 8 Periodically (at least once a year) surveillance audits by your Notified Body 9 Unannounced audits 10 Post market surveillance/clinical follow up 22 CE-Marking: Notified Body Notified Body What is a Notified Body? A private organisation, operating in a competitive market Notified by the European Commission. Monitored by a member state: Competent Authority e.g. Belgium: FAGG / AFMPS / FAMHP (Federal Agency for Medicines and Health Products) New: Joint Assessments of medical devices Notified Bodies by Member States and Commission Experts Role of a Notified Body Provide services for conformity assessment on the conditions set out in the directives in support of CE marking Normally: assessing the manufacturers conformity to the essential requirements listed in each directive. Inspection Quality assurance Type examination Design examination Combination of above 23 CE-Marking: Notified Body EU Commission Etc. Etc. Competent Authority Sweden Competent Authority Belgium F.A.G.G./A.F.M.P.S. Competent Authority UK - MHRA Etc. Notified Bodies Sweden Notified Bodies Belgium SGS Belgium NV Notified Bodies UK SGS United Kingdom Ltd Etc. Notified Body 1639 Notified Body 0120 Manufacturer UK Manufacturer Overseas Authorised Representative 24 8

9 CE Marking for Medical devices Part 2: Conformity assessment procedure GET YOUR MEDICAL DEVICES TO MARKET FASTER WHEN YOU KNOW THE WAY 25 CE-Marking: Conformity assessment procedure Conformity assessment procedure: 1 It is the choice of the manufacturer 2 Possible choices depends from the classification of the medical device 3 The choice has an impact on the quality system and the certification 4 Different routes: historically due to national different approach on how to assess the safety and effectiveness of medical devices 5 Described in the Medical Device Directive and in different guidance documents e.g. 26 CE-Marking: Conformity assessment procedure 27 9

10 CE-Marking: Conformity assessment procedure 28 CE Marking for Medical devices Part 3: Technical documentation GET YOUR MEDICAL DEVICES TO MARKET FASTER WHEN YOU KNOW THE WAY 29 CE-Marking: technical documentation Specified in MDD 93/42/EEC annex VII annex II One of the aims: to prove that the device is in conformity with the essential requirements of the MDD (see annex 1 of the MDD) Described in document NB MED 2.5.1(rev.5): Technical Documentation For class I, IIa, IIb en III Also applicable document GHTF/SG1/N011:2008: Summary Technical Documentation (STED) Extent of the technical documentation depends on: Classification, complexity, Use of innovative technology, product, 30 10

11 CE-Marking: technical documentation Possible structure 1 Device description and product specification 2 Labelling (or draft labelling ) 3 Design and Manufacturing Information 4 Essential Requirements Checklist 5 Risk management file 6 Verification and validation of the device 7 Required declarations (or proof if such a declaration is not possible) 8 Declaration of Conformity : 31 CE-Marking: technical documentation 1 Device description and product specification a. Device description: Intended use/purpose e.g. This medical disinfectants is intended for chemically disinfecting of non-invasive medical devices. It is used during the washing process of surgical drapes. Intended patient population and medical condition Principles of operation of the device; Classification (and motivation) e.g. The sterile infusion cannulae are surgically invasive The cannulae are intended for short-term use (more than 60 minutes, but less than 30 days). The cannulae are not in direct contact with the heart, central circulatory or central nervous system The Cannulae are chemical inert in the body, don t have biological effect and don t supply energy => Annex IX, rule 7, class IIa Chosen annex of MDD 93/42/EEC for the conformity assessment procedure (annex II, VII+V, ) Accessories Variants 32 CE-Marking: technical documentation 1 Device description and product specification (continuation) b. Product specification as in brochures and other information made available to the end user, including Features performance attributes If applicable: dimensions Variants and accessories c. Reference to the manufacturer s previous generation(s) of the device, if such exist, or (if relevant) similar devices available on the market

12 CE-Marking: technical documentation 2 Labelling (or draft labelling ) a. Labels put on the device and packaging b. Instructions for use, technical manual,... c. Promotional / commercial material 34 CE-Marking: technical documentation 3 Design and Manufacturing Information a. Design of the device (e.g. flowchart for class I, IIa en IIb) b. Production processes (e.g. Flowchart with reference to procedures, workinstructions,...) c. Design- and production sites and how they are controlled (+ ISO certificates) => this is a equivalent to Device Master Record (cookbook) 35 CE-Marking: technical documentation 4 Essential Requirements Checklist (MDD annex 1: can be downloaded f.e.eucomed): Take care: all amendments of 2007/47/EC Take care: is also machinery of personal protective equipment directive applicable? a. Well motivated 1 Critical (pre)clinical evaluation 2 Relevant harmonised standards 3 Tests, Studies, publications, research, : Biocompatibility studies, Laboratory tests, Simulated use tests 4 (critical) comparison with existing (comparable) devices: published literature regarding the device or substantially similar devices. b. Don t forget to motivate all essential requirement deemed NOT applicable even it seems streight forward

13 CE-Marking: technical documentation 5 Risk management file a. ISO14971:2007: this is a whole process b. Multidisciplinary team c. Not only risk analysis, but also risk control measures and reducing the risk to an acceptable level. 37 CE-Marking: technical documentation 6 Verification and validation of the device a. All studies, all tests, all data, all publications a.o. that are used to prove that the device meets the essential requirements. Test reports of harmonised standards are necessary (if relevant) b. Biocompatibility c. Medicinal substances d. Biological safety of devices incorporating animal or human cells, tissues or their derivatives: 38 CE-Marking: technical documentation e. Sterility 1. Bioburden tests 2. Pyrogenity tests 3. Testing for sterilant residues (if applicable) 4. Packaging validation f. Software verification and validation (Harmonised standard ISO 62304:2006) g. Pre-clinical evaluation h. Clinical evaluation 1. Obligatory for class IIa, IIb and III medical devices 2. Can be based on clinical trials/studies, but is not obligatory, except for class III medical devices 3. Can be based on critical literature study 4. Bibliography alone is deemed insufficient as clinical evaluation! 5. Following Directieve annex X en MEDDEV latest revision i. Life time or shelf life of the medical device Rapport of aging tests Motivated expected lifetime 39 13

14 CE-Marking: technical documentation 7 Required declarations (or proof if such a declaration is not possible): a. Device doesn t contain animal tissue b. Device doesn t contain phthalates c. Device doesn t contain human cells, blood, tissues or their derivatives; d. Device doesn t contain pharmacological components 8 Declaration of Conformity a. During initial assessment by a Notified Body: only Draft version possible b. On official company paper (containing logo a.o.) c. Classification d. Chosen conformity route (chosen annex of the MDD) e. Used harmonised technical standards f. Trade name (if different), product name, product code and/or other unambiguous reference of the device(s) g. Reference to the CE certificate, h. Signed by qualified person and dated 40 CE-Marking: technical documentation: DoC EC DECLARATION OF CONFORMITY We, (Name + address of the (authorised representative of the) manufacturer) hereby declare under our sole responsibility that the CE marked product(s) to which this declaration relates, (trade name if different, product name, product code and/or other unambiguous reference of the Device(s)) (has)(have) been classified as Class, according to Annex IX, rule, and (are)(is) in conformity with the essential requirements and provisions of the Council Directive 93/42/EEC concerning medical devices 41 CE Marking for Medical devices Part 4: Medical quality system ISO 13485:2003 GET YOUR MEDICAL DEVICES TO MARKET FASTER WHEN YOU KNOW THE WAY 42 14

15 CE-Marking: Medical quality system Technical documentation + Quality system Quality (management) system: harmonised standard EN ISO13485:2012! 1. Quality manual + procedures/work instructions/documents/ How are critical subcontractors controlled 3. Risk management procedure 4. Procedures for all regulatory requirements: a. Vigilance procedure (incidents or near incidents) b. Classification, c. Clinical evaluation, d. Unannounced audits,... e. Translation procedure (if applicable) f. Post market surveillance procedure g. Post-market clinical follow-up procedure h CE-Marking: Medical quality system EN ISO13485:2012 : the promotion and awareness of regulatory requirements as a management responsibility. controls in the work environment to ensure product safety focus on risk management activities and design transfer activities during product development specific requirements for inspection and traceability for implantable devices specific requirements for documentation and validation of processes for sterile medical devices specific requirements for verification of the effectiveness of corrective and preventive actions EN ISO13485:2016: is now publicised, but not yet harmonised (March 2016) 44 CE-Marking: audit cycle: certification 45 15

16 CE-Marking: audit cycle: surveillance visits 1. At least once a year surveillance visits according to MDD (and harmonised standards EN ISO13485:2012) 2. Unannounced audits 3. Important in the quality system: Regulatory and statutory documents containing also harmonised standards and official guidance documents e.g. MedDev documents Post-market clinical follow-up e.g. Complaints, client feed-back, but also clinical feed-back Unexpected/adverse effects New publications, new technologies, Post market surveillance and Vigilance (Fields Safety Actions or Notices) Control of subcontractors e.g. validity of quality management certificates (ISO13485:2003, GMP ) Notifications of relevant changes to the quality system and/of device 4. Important in the technical file: Changes that didn t required immediate reassessment Risk management file: this is living document Clinical evaluation: this is a living document State-of-the-art Full (re)assessment possible 46 information sources (ordered by relevance) 1 National transposition of the European Directives 2 European Directives: 3 MedDev documents (publicised by the European Commission: de facto obligatory) 4 Harmonised standards (name of standards publicised by the European Commission: de facto obligatory) 5 NB Med documents (publicised by the Notified Bodies Medical Devices) 6 IMDRF (International Medical Device Regulators Forum) and GHTF 7 Notified Bodies en Competent Authorities SGS: MHRA: 47 New Medical Device Regulations (MDR) 5 May 2017: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 78/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC => also called: MDR 48 16

17 New Medical Device Regulations (MDR): MDR chapters I. Scope and definitions II. III. Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement. Identification and traceability of devices and of economic operators, summary of safety and clinical performance, European database on medical devices. IV. Notified bodies V. Classification and conformity assessment VI. Clinical evaluation and clinical investigations VII. Post-market surveillance, vigilance and market surveillance VIII. Cooperation between Member States, medic device Coordination Group, expert laboratories, expert panels and device register. IX. Confidentiality, data protection, funding and penalties X. final provisions. 49 New Medical Device Regulations (MDR): MDR Annexes I. General Safety and Performance Requirements II. III. Technical Documentation Technical Documentation on Post-Market Surveillance IV. EU Declaration of Conformity V. CE Marking of Conformity VI. A. Information to be submitted upon registration of devices and Economic Operators in accordance with Articles 29(4) and 31, B. Core data elements to be provided to the UDI Database together with the UDI-DI [UDI device identifier] in accordance with Articles 28 and 29 C. the UDI System VII. Requirements to be met by Notified Bodies VIII.Classification Rules IX. Conformity assessment based on a Quality Management system and on assessment of Technical Documentation X. Conformity assessment based Type-Examination 50 New Medical Device Regulations (MDR) XI. Conformity assessment based on Product Conformity Verification XII. Certificates issued by a Notified Body XIII.Procedure for Custom-Made Devices XIV.Clinical Evaluation and Post-Market Clinical Follow-Up XV. Clinical Investigations XVI.List of groups of products without an intended medical purpose referred to in Article (2) XVII.Correlation Table 51 17

18 New Medical Device Regulations (MDR) 52 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: Software as Medical Device 54 18

19 MDR: Software as Medical Device 55 Rule 11 MDR: Software as Medical Device Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: death or an irreversible deterioration of a person's state of health, in which case it is in class III; or a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb. Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I. 56 MDR: Software as Medical Device Rule 11 Not just decisions made by the software itself, but Software also decisions intended to made provide by information doctors and which patients, is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if hardware or other software medical devices. such decisions have an impact that may cause: death or an irreversible deterioration of a person's state of health, in which case it is in class III; or a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb. Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I

20 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions Article 7: Claims MDR: Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: a) ascribing functions and properties to the device which the device does not have; b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. 59 Article 7: Claims MDR: Claims Don t forget to inform all likely risks (including contra-indications and side-effects) Indications Consistent in thetechnical Documentation, in all labelling, in advertising,... All claims shall be proven in the clincial evaluation file Shall be described in the IFU Contra-indications Consistent in thetechnical Documentation Are described in the risk management file Are the outcome of the clincial evaluation file Shall be described in the IFU Side-effects Consistent in thetechnical Documentation Are described in the risk management file Are the outcome of the clincial evaluation file Shall be described in the IFU 60 20

21 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: Authorised Representative Article 11: if the legal manufacturer is not in a Member State: a sole authorised representative...and same for generic device group mandate accepted in writing by the authorised representative the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. authorised representative... terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and shall immediately inform the competent authority of the Member State and the notified body Article 12: change of Authorised Representative detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative 62 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions

22 MDR: Supply Chain Explicit obligations imposed on importers (art. 13) and distributors (art. 14) (check your contracts!) 64 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: Own Brand Labelling/Manufacturing (OBL/OBM) Cases in which obligations of manufacturers apply to importers, distributors or other persons (art 16) A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation; b) changes the intended purpose of a device already placed on the market or put into service; c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. => OBL (Own Brand Labelling/Manufacturing) doesn t exists anymore! 66 22

23 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: Person responsible for regulatory compliance Person responsible for regulatory compliance (art. 15) Manufacturers (and authorised representatives) 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. requisite expertise is described in art. 15 Except: companies < 50 Employees and < 10 Mio Revenue shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal 68 MDR: Person responsible for regulatory compliance Person responsible for regulatory compliance (art. 15) The person responsible for regulatory compliance shall at least be responsible for ensuring that: a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; c) the post-market surveillance obligations are complied with in accordance with Article 10(10); d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; 69 23

24 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: Identification and traceability Unique Device Identification system ( UDI system ) (art. 27) 1. a UDI device identifier ( UDI-DI ) specific to a manufacturer and a device, 2. a UDI production identifier ( UDI-PI ) that identifies the unit of device production and if applicable the packaged devices => Aim: facilitate identification and traceability e.g. UDI shall be used for reporting serious incidents and field safety corrective actions the manufacturer shall assign to the device a UDI created in compliance with the rules placing of the UDI on the label of the device or on its packaging; UDI-DI of the device shall appear on the EU declaration of conformity storage of the UDI by economic operators, health institutions and healthcare professionals electronic system for Unique Device Identification ( UDI database ). 71 UDI UDI: a system covering 3 elements 1. UDI-code Unique Device Identification CODE DI: Device ID: unique numeric or alphanumeric code specific to a manufacturer and a device model PI: Product Identifier: lot/batch no., serial no., expiry [use by] date, date of manufacture [in any combination] 2. AIDC Automatic Identification and Data Capture 3. UDID: UDI database: DI is key in this database 72 24

25 MDR: Identification and traceability Electronic system for registration of economic operators (art. 30 and 31) 1. single registration number to identify the manufacturer and, where applicable, the authorised representative and the importer 2. national provisions on registration of distributors of devices 73 UDI: interaction between UDI and Eudamed 74 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions

26 New MDR: CER 76 New MDR: CER 77 New MDR: CER 78 26

27 New MDR: CER Periodic Safety Report: 79 New MDR: CER Class III and implantable devices: SSCP Made available to public via Eudamed 80 New MDR: CER 81 27

28 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions MDR: National Implementation However: (supplementary) national regulation still expected/possible For example: Reusability of Single Use Devices Registration of distributors Some aspects concerning Clinical Investigations: E.g. compensation and insurance system fines and penalties taxes and fees for carrying out market surveillance 83 New Medical Device Regulations (MDR): some focus 1. Software as Medical Device 2. Claims 3. Authorised Representative 4. Supply Chain / Economic operators 5. Person responsible for regulatory compliance 6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons 7. Identification and traceability 8. Upgrade of the Clinical Evaluation and Clinical Investigation 9. National Implementation 10.Entry into force, application, transition provisions

29 MDR: Entry into force, application, transition provisions New Medical Device Regulations (MDR) 86 29