How to Prepare for the New EU Medical Device Regulations (MDR)
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The document presents a comprehensive overview of the new EU medical device regulations, detailing the changes and their implications for manufacturers, including risk assessment, classification criteria, and post-market surveillance requirements. It discusses the transition from existing regulations to more stringent requirements and focuses heavily on the critical role of documentation and compliance for medical device companies operating in the EU. The presentation emphasizes the significance of planning and teamwork within organizations to adapt to the evolving regulatory landscape.
How to Prepare for the New EU Medical Device Regulations (MDR)
- 1. Presented by: Richard Young Managing Director, ABC How to Prepare for the New EU Medical Device Regulations
- 2. greenlight.guru is the Only Quality Management Software Built Exclusively for Medical Device Companies
- 3. About the Presenter Richard Young (BSc (Hon) MSc, AIQA, ) is the Managing Director of Acclaim Biomedical Consulting Ltd, a specialist consulting company, based in Europe, which aims to support developing companies through the hurdles of global regulatory compliance, marketing and clinical research. Richard has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management. Richard has been an active member of many groups through his time in industry, including representing industry in the formation of the “beyond compliance initiative” and spending many years on the Eucomed Standards Focus Group as well as standards groups such as LBI 35. Over the last few years, his consulting activities have included a large proportion of training and education including teaching at Sheffield Hallam University in the UK on a Post Graduate Diploma Course.
- 4. Today’s Agenda Introduction 5 min. Why are European Regs Changing 5 min. What are the changes? 60 min. Questions 20 min.
- 5. • Gain an overview of the text being voted on • Why was the Regulation created? • What does the new Regulation mean for manufacturers? • Where are we now? We will cover
- 6. • Examine the risk based approach to classification • Inherent risk to the patient / population • Novelty • Complexity • Strategy for Technical Documentation Preparation • A revised STED format? • Clinical Evidence for Devices • Post market surveillance and vigilance for Medical Devices • Routine operations in the new environment We will cover
- 7. • Concerns from regulators – addressing concerns from the various scandals • PIP • ASR • Address regulatory weaknesses (NBs, availability of information) to increase confidence • International harmonization – implementing GHTF/IMDRF • Problems on implementation – lack of resources and lack of harmonization at the EU level • Shift from DG Enterprise to DG Sanco = shift of emphasis from business • Universal implementation across member states as a regulation Why do we need a new regulation?
- 8. • Scope changes concern extension and clarification, mainly as with respect to: • Medical software, which is explicitly mentioned in the definition of Devices. • CS Documents • MDCG Oversight • Qualified Persons • Clinical Evidence • Transparency • Reference Laboratories • Economic Operators • UDI Scope
- 9. • See elements of QMS and risk based structure in a STED like format • ISO 13485 :2016 • MDSAP IMDRF
- 10. • Original Goal was transposition in Q4 2014 • Most recent Drafts by Latvian Presidency June 2015 • Review Q4 2015 • Final Text agreed in May 2016 • Was due to be voted on in September 2016 Current program
- 11. • Council of the European Union • Brussels, 12 June 2015 • New version published in May 2016 • There were 24 Articles, there are now 97 • Now 16 Annex’s The Text of the Regulation
- 12. Detail: The Articles & Annex's
- 13. • I General safety and performance requirements • II Technical documentation • IIa Technical documentation on post-‐market surveillance • III EU Declaration of conformity • IV CE marking of conformity • V Information to be submitted with the registration of devices and economic operators in accordance with Article 23 and data elements of the UDI device identifier in accordance with Article 22 • VI Minimum requirements to be met by Notified Bodies • VII Classification criteria The Annex's
- 14. • VIII Conformity assessment based on full quality assurance and design examination • IX Conformity assessment based on type examination • X Conformity assessment based on production quality assurance • XI Custom Made Devices • XII Minimum content of certificates issued by a notified body • XIII Clinical evidence and post-‐market follow-‐up • XIV Clinical Investigations • XV Products without intended medical purpose • XVI Correlation table The Annex's Continued
- 15. The Articles: Major Areas of Change and Impact
- 16. • Majorly important for higher classification products • Assess exposure early • Expect ongoing activity -‐ monitor COMMENT
- 17. Reference Labs and MDCG
- 18. • (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; • (ac) to advise the Commission, at its request, in matters concerning the coordination group of Notified Bodies as established pursuant to Article 39; • (c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation and investigations by manufacturers, the assessment by notified bodies and the vigilance activities; Article 78/80 Defines tasks for MDCG
- 19. • Temporary or standing • Will have common standards and references and conduct peer reviews • Can cover Clinical Evaluation • Fees will be levied Article 81 Scientific Advice and Expert Panels/Laboratories
- 20. • Medical Device Coordination Group (MDCG). Chaired by the Commission, the group is composed of representatives of Member States • contribute to the assessment of applicant conformity assessment bodies and Notified Bodies; • contribute to the scrutiny of certain conformity assessments under the scrutiny procedure; • contribute to the development of guidance aimed at ensuring effective and harmonised implementation of the regulation, in particular regarding the designation and monitoring of Notified Bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by Notified Bodies; Article 7 CS via MDCG
- 21. • Very powerful addition to the regulations • Continuous state of the art • Un-‐budgeted expense of additional testing • Significant impact on lead-‐times COMMENT
- 23. • Article 11 Obligations for importers • Obliged to verify devices are CE marked with an appropriate declaration • Authorised rep is in place • Labelled correctly • UDI • Obligation to inform their CA if serious risk or falsified? • Additional labelling identifying importer, or accompanying document • Register according to article 25 Economic Operators
- 24. • Article 12 Distributor obligations • Same verification obligations as importers • Register complaints • Provide free samples to CA or grant access • Check the importer and AR details are correct • Sample as required Economic Operators
- 25. • Definition of responsibilities and contracts are critical • Communications and document control also critical • Major expense potentially to manage going forwards, treat as approved distributors • Consider certification requirements • Remember AR role is changing as well COMMENT
- 27. • Duration of Use • Transient • Short Term • Long Term • Invasiveness • Body Orifice • Surgical • Reusable surgical instruments Criteria
- 28. • Majorly important for most products, a clear classification rationale against these requirements should be a priority as it defines organisational exposure • Note specific additions including software • Full set of rules are appended to this presentation COMMENT
- 29. • Will apply to class III and IIb devices but potentially to many others • Any specific categories or group of devices that Commission determines reasonable concern • Potentially a significant burden on the manufacturer in terms of time and money. Article 44 Scrutiny procedure
- 31. • This is a one off element so while will extend time to market this is a one off. COMMENT
- 32. • STED LIKE FORMAT • 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND • ACCESSORIES • 1.1. Device description and specification • Including UDI • 2. INFORMATION SUPPLIED BY THE MANUFACTURER • 3. DESIGN AND MANUFACTURING INFORMATION • 3.1. Design information • 3.2. Manufacturing information • 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS • 5. RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT Annex II Technical Documentation
- 33. • Pre-‐clinical and clinical data Sterility / Sterilisation validation Biocompatibility Materials characterisation Electrical Safety Software V&V Stability and shelf-‐life Performance and safety Clinical Evaluation report and updates PMCF plan or justification why not being conducted Source data and controls on materials of human origin Source data and controls on materials of animal origin Data regarding materials to be adsorbed into the body 6. PRODUCT VERIFICATION AND VALIDATION
- 34. • TECHNICAL DOCUMENTATION ON POST-‐MARKET SURVEILLANCE • 1.1. Post-‐market surveillance plan in accordance with Article 60. • 1.2. Post-‐market performance follow-‐up evaluation report in accordance with Part B of Annex XII. • 1.3. Periodic safety update report referred to in Article 60c. submitted annually electronically Annex IIa
- 35. • (a) the conclusion of the benefit risk determination; • (b) the main findings of the Post Market Clinical Follow-‐up Report and • (c) the volume of sales of devices and an estimate of the population that use the device involved and, where practicable, the usage frequency of the device. • Manufacturers of class IIb and III devices shall update the report at least annually and it shall, except in the case of custom made medical devices, be part of the technical documentation as specified in Annexes II and IIa. • Manufacturers of class IIa devices shall update the report when necessary and at least every two years; and it shall, except in the case of custom made medical devices, be part of the technical documentation as specified in Annexes II and IIa. Annex IIa
- 36. • Major ongoing impact for all organisations • Document Management is absolutely Critical!!!! • Clinical and technical resources will be a premium!!!! • Annual requirement, large portfolio impact • Data is king!! • These resources will be scarce given the need to experienced persons across Notified Bodies and medical device sector in general COMMENT
- 38. • State of the Art • Reduce risks as far as possible without adversely affecting the risk benefit ratio. • 1 risk management is required • 2 solutions must eliminate risks as far as possible through design and construction, then alarms, then instructions for use Ergonomic features, IEC 62366 not specifically referenced by implicit as is for intended users • 3 under normal conditions won’t impact health and safety of User or patient in product lifecycle. • 4 performance won’t be impacted by transport and storage • 5 undesirable effects weighed against evaluated potential benefits Annex I General Requirements
- 39. 6 For devices listed in Annex XV for which the manufacturer does not claim a medical purpose, the general safety requirements set out in Sections 1 and 5 shall be understood that the device, when used under the conditions and for the purposes intended, shall not present any risk or no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons. Annex I General Requirements
- 40. 7 Chemical physical and biological properties • Note adsorbed materials • Carcinogens and endocrine disrupting materials (0.1% w/w) will require close monitoring • CMR substances • Phthalates • Labelling requirements 8 Infection and Microbial Contamination • Safe cleaning by design Annex I General Requirements
- 41. 9 Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or combination of substances that are absorbed by or locally dispersed in the human body 10 Devices incorporating materials of biological origin 11 Construction of devices and interaction with their environment • Misconnections • Human Factors • Usability Annex I General Requirements
- 42. 12 Devices with a diagnostic or measuring function 13 Protection against Radiation 14 Electronic programmable systems -‐ Devices that incorporate electronic programmable systems and software that are devices in themselves • cyber security included 15 Active devices and devices connected to them • Alarms and power supplies • Avoid unauthorised access by design? • Electrical Safety Annex I General Requirements
- 43. 16 Protection against mechanical and thermal risks 17 Protection against the risks posed to the patient or user by supplied energy or substances 18 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons • Design for intended user • Avoid needle stick injuries etc Annex I General Requirements
- 44. 19 Label and Instructions for Use • Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, • Specific requirement for disinfection instructions • Materials and substances listed (absorbed) Annex I General Requirements
- 45. • Massive expansion in essential requirements especially in labelling • Will be particularly challenging retrospectively applying these to existing products • Internet will be an important strategic option but must be controlled and maintained COMMENT
- 47. • Clinical Investigations • Pre Market • Ethics covered very well • Timings and route to study Annex XIV
- 48. • Articles 49-‐58 • Clinical study plan and exhaustive listing of content which can be amended with a documented rationale including: • Full description including monitoring • Data management • Overall description • Sampling plan • Sponsor • Investigator • Suspension and termination criteria • Reportable events Clinical Investigations
- 49. • CLINICAL EVIDENCE AND POST-‐MARKET FOLLOW-‐UP • Performance Evaluation a continuous process • Performance evaluation plan required and shall describe all relevant elements of the device • The plan shall be scientifically valid Annex XIII
- 50. • A continuous process to update the performance evaluation referred to in Article 60 and Part A of Annex XII and shall be part of the manufacturer's PMSP • Have a PMCF plan • Confirm safety and performance • Identify new risks • Analyse risks • Identify misuse!! Post-‐market clinical follow-‐up (PMCF)
- 51. • Rationale for not conducting PMCF required • Detailed planning and control of these studies will be required • Ongoing resource requirement COMMENT
- 52. • How do we go forwards?.................. Implementation and evaluation
- 53. • There are some things we do know – start planning! • No grandfathering for existing products 2 years on existing certified products • There will be rules based classification – how will this affect your catalogue? • Now is the time for teamwork – your RA colleagues will be crucial Analyse
- 54. • Classify Devices (any significant changes?) • Collect Data • Consider Authorised Representative • Verify Distribution Chain • Work with Notified Body • Consider Qualified Persons • Unique Device Identification • Impact on global strategy
- 55. • Impact on Clinical Evidence program • Consider product portfolio? • Product pipeline and development cycle
- 56. Closing
- 57. Questions Contact Acclaim Biomedical Consulting for Your EU Medical Device Regulation Training Needs www.acclaimbiomedical.co.uk
- 59. All non-‐invasive devices are in class I, unless one of the rules set out hereinafter applies. Rule 1
- 60. All non-‐invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in class IIa: • if they may be connected to an active medical device in class IIa or a higher class, • if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags, which are in class IIb. In all other cases they are in class I. Rule 2
- 61. All non-‐invasive devices intended 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 in class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in class IIa. • All non-‐invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken off from the human body or with human embryos before their implantation or administration into the body are in class III. Rule 3
- 62. All non-‐invasive devices which come into contact with injured skin or mucous membrane: • are in class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, • are in class IIb 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, • are in class IIa in all other cases, including devices principally intended to manage the micro-‐environment of injured skin or mucous membrane. • This rule applies also to the invasive devices that come into contact with injured mucous membrane. Rule 4
- 63. Invasive Devices
- 64. All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active medical device or which are intended for connection to a class I active medical device: • are in class I if they are intended for transient use, • are in class IIa if they are intended for short-‐term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are in class I, • are in class IIb if they are intended for long-‐term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in class IIa. • All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in class IIa or a higher class, are in class IIa. Rule 5
- 65. All surgically invasive devices intended for transient use are in class IIa unless they: • are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III, • are reusable surgical instruments, in which case they are in class I, • are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are in class III, • are intended to supply energy in the form of ionising radiation in which case they are in class IIb, • have a biological effect or are wholly or mainly absorbed in which case they are in class IIb, • are intended to administer medicinal products by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in class IIb. Rule 6
- 66. All surgically invasive devices intended for short-‐term use are in class IIa unless they: • are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III, • are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are in class III, • are intended to supply energy in the form of ionizing radiation in which case they are in class IIb, • have a biological effect or are wholly or mainly absorbed in which case they are in class III, • are intended to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in class IIb. Rule 7
- 67. All implantable devices and long-‐term surgically invasive devices are in class IIb unless they: • are intended to be placed in the teeth, in which case they are in class IIa, • are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in class III, • have a biological effect or are wholly or mainly absorbed, in which case they are in class III, • are intended to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicinal products, in which case they are in class III, • are active implantable devices or their accessories, in which case they are in class III, • are breast implants or surgical meshes, in which case they are in class III; • are total and partial joint replacements, in which case they are in class III, with the exception of ancillary components such as screws, wedges, plates and instruments, • are spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III with the exception of components such as screws, wedges, plates and instruments. Rule 8
- 68. Active Devices
- 69. All active therapeutic devices intended to administer or exchange energy are in class Iia unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in class IIb. All active devices intended to control or monitor the performance of active therapeutic devices in class IIb, or intended directly to influence the performance of such devices are in class IIb. All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are in class IIb. All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are in class III. Rule 9
- 70. Active devices intended for diagnosis and monitoring are in class IIa: • if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are in class I, • if they are intended to image in vivo distribution of radiopharmaceuticals, • if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system or diagnosis in clinical situations where the patient is in immediate danger, in which case they are in class IIb. Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are in class IIb. Rule 10
- 71. • Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, is in class IIa, except if such decisions have an impact that may directly or indirectly cause: • the death or an irreversible deterioration of the state of health, in which case it is in class III; • a serious deterioration of the state of health or a surgical intervention, in which case it is in class IIb. • Software intended to monitor physiological processes is in class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb. • All other software is in class I. Rule 10a
- 72. All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are in class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in class IIb. Rule 11
- 73. All other active devices are in class I. Rule 12
- 74. Special Rules
- 75. All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, with action ancillary to that of the devices, are in class III. Rule 13
- 76. All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in class IIb, unless they are implantable or long term invasive devices, in which case they are in class III. Rule 14
- 77. All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in class IIb. All devices intended specifically to be used for disinfecting or sterilising medical devices are in class IIa, unless they are disinfecting solutions or washer-‐disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are in class IIb. This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only. Rule 15
- 78. • Devices specifically intended for recording of diagnostic images generated by X-‐ray are in class IIa. Rule 16
- 79. • All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-‐viable or rendered non-‐viable are in class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-‐viable or rendered non-‐viable that are intended to come into contact with intact skin only. Rule 17
- 80. All devices incorporating or consisting of nanomaterial are: • in class III if they present a high or medium potential for internal exposure; • in class IIb if they present a low potential for internal exposure; • in class IIa if they present a negligible potential for internal exposure. Rule 18
- 81. Devices that are composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body are: • -‐ in class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose, • -‐ in class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body, • -‐ in class IIb in all other cases, except if they are applied on skin, in which case they are in class IIa, or • -‐ if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, in which case they are in class IIa Rule 21
- 82. All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are in class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product and those that are intended to treat life threatening conditions, in which case they are in class IIb. Rule 22
- 83. Active therapeutic devices with an integrated or incorporated diagnostic function, which significantly determinates the patient management by the device are in class III, such as closed loop systems or automated external defibrillators. Rule 23