The Basic UDI-DI is the main access key for device-related information in the EUDAMED database to ensure ease of reference and traceability the UDI should be clearly displayed on - Certificates issued in relation to a device e.g. certificate of free sale - EU declaration of conformity - Technical documentation - Summary of safety and (clinical) performance) - Vigilance and FSCA notification form It is important to note that the UDI-DI shall not appear on the device label or packaging or on any trade item, it is administrative only. UDI-DI is the device identifier. This is the static part of the UDI number. It doesn´t change within the same exact product. The “Basic UDI-DI” intended to group devices with the same intended purpose, risk class, essential design and manufacturing characteristics. Basic UDI-DI is a numeric or alphanumeric code. UDI-PI is the production identifier. It is the dynamic part of the UDI including: - Serial number - batch/lot number - Manufacturing date - Expiry date
52 www.gandlhealth.com Eudamed Module 1 Device registrations Module 2 UDI data base Module 3 Registration of economic operators Module 4 Notified bodies and certificates Module 5 Clinical investigations Module 6 Vigilance and post market surveillance reports and summaries Transparency
EUDAMED is a European database on medical devices and provides a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It integrates different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU. • Commission and member states have access to all information • Manufacturers will have access to their respective data • Public will have access to some information What will be contained in EUDAMED (a)the list of subsidiaries referred to in Article 37(3); (b)the list of experts referred to in Article 40(2); (c)the information relating to the notification referred to in Article 42(10) and the amended notifications referred to in Article 46(2); (d)the list of notified bodies referred to in Article 43(2); (e)the summary of the report referred to in Article 44(12); (f) the notifications for conformity assessments and certificates referred to in Articles 54(3) and 55(1); g) withdrawal or refusals of applications for the certificates as referred to in Article 53(2) and Section 4.3 of Annex VII; h) the information regarding certificates referred to in Article 56(5); (i) the summary of safety and clinical performance referred to in Article 32. 2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, where appropriate to the notified bodies and were provided elsewhere in this regulation or in Regulation (EU) 2017/746 to the public.
54 www.gandlhealth.com Traceability Traceability of devices to be kept for 10 years (15 years for implantable devices) after last device was placed on the market Economic Operator A Economic Operator B Economic Operator C Health Institute Article 30 Article 31
The following positions in the lifecycle of a medical device will need to register as an Economic Operator (EO) A: The manufacturer, B: Authorised Rep, C: Importer or Distributor, there could be a number more in the chain. Economic operator will need to record devices received and passed on. To record devices EUDAMED database is being created with access to a free database so that a common dictionary is used for device types. https://health.ec.europa.eu/medical-devices-eudamed_en
56 www.gandlhealth.com The SSCP is a mandatory requirement of the MDR for all Class III* and Implantable Devices. The SSCP will be published within EUDAMED and is publicly available. • Requirements for the Summary of Safety and Clinical Performance (SSCP) are established in Article 32 • NB will review during assessment of Technical Document and validate that the SSCP correctly includes all of the required elements¥ • Label or IFU needs to state that SSCP is available on EUDAMED where it is linked to the UDI Summary of Safety and Clinical Performance (SSCP) Article 32
*Note SSCP is not necessarily required for custom-made devices SSCP must be written in such a way that the information within is clear and accessible and understandable by both healthcare professionals and patients. It is intended to include information on the safety and clinical performance of the product and to enhance transparency – must contain favourable and unfavourable data, i.e. adverse events etc., The SSCP is not intended to: • give general advice on the diagnosis or treatment of particular medical conditions, nor • replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular device, nor • replace the mandatory information on implant cards or in any other mandatory documents. ¥ The timing of this validation depends on the class of device and the conformity assessment route • Changes - EO must update within 1 week • Competent Authority can charge a fee • Routine check will be required to confirm certain data (EO) remains accurate.
58 www.gandlhealth.com NBs NBs NBs Key Stakeholders Regulatory Agencies / Competent Authorities Notified Bodies European committees and organisations Chapter IV Notified Bodies (NBs) Articles 35 - 50
The articles contained within chapter IV : 35.Authorities responsible for notified bodies 36.Requirements relating to notified bodies 37.Subsidiaries and subcontracting 38.Application by conformity assessment bodies for designation 39.Assessment of the application 40.Nomination of experts for joint assessment of applications for notification 41.Language requirements 42.Designation and notification procedure 43.Identification number and list of notified bodies 44.Monitoring and re-assessment of notified bodies 45.Review of notified body assessment of technical documentation and clinical evaluation documentation 46.Changes to designations and notifications 47.Challenge to the competence of notified bodies 48.Peer review and exchange of experience between authorities responsible for notified bodies 49.Coordination of notified bodies 50.List of standard fees
60 www.gandlhealth.com European Regulatory Agencies European Commission (EC) Legislation produced for both medicines and devices Medical devices http://ec.europa.eu/growth/sectors/medical-devices/ MDR responsibility moved from DG Health to DG Sante Jan 2020 Medicinal products http://ec.europa.eu/health/human-use/ European Medicines Agency (EMA) Manage medicinal product procedures (as yet limited device involvement) http://www.ema.europa.eu/ema/ Committee of Human Pharmaceutical Products (CHMP) Provide scientific assessment with the support of specialised working groups
61 www.gandlhealth.com National Regulatory Agencies Some countries have one agency that implements both medical device and medicinal product legislation e.g. Ireland Other countries have separate agencies. Netherlands Health Care Inspectorate – Devices. Netherlands Medicine Evaluation Board – Medicines.
In the case of medical devices, Article 101 of Regulation (EU) 2017/745, each Member State shall designate a competent authority that will be responsible for implementing this Regulation. The competent authority belongs to the government of the Member State of the European Union (EU) and their responsibility is to transposes the requirements of European regulations into national legislation. The CAs are responsible for the following MDR-related activates: • Assessment and designation of Notifies Bodies to the EC based on assessed ability (NB) • Inspect, Audit and “DE Notify” NB , including during NB activities • Interpretation and Guidance on law (e.g., classification) • Can ask the EU Commission for a classification decision • Can inspect Class I Manufacturers • Surveillance responsibilities • Oversees that manufacturer investigates serious incidents and implements corrective action (if necessary) • Informs other EU countries when a local manufacturer has a corrective action • Authorisation of clinical investigations • On going post-market communications – certificates withdrawn or suspended • Maintains national device register (class I database and EUDAMED)
63 www.gandlhealth.com Some MDR NBs IMQ (Instituto Italiano del Marchio di Qualita S.P.A. Italy GMED France DNV Product Assurance B.V Norway BSI GROUP the Netherlands B.V. National Standards Authority of Ireland (NSAI) Dekra GmbH Germany Intertek Medical Notified Body AB Sweden Eurofins Expert Services Oy Finland CE Certiso Orvos Hungary UDEM Adriatic d.o.o Croatia
64 www.gandlhealth.com Annex VII – Classification rules Classification of Devices Reclassification of devices Chapter V Classification and Conformity Assessment Articles 51- 60
Chapter V contains the following Articles: Section 1 CLASSIFICATION 51. Classification of devices Section 2 CONFORMITY ASSESSMENT 52. Conformity assessment procedures 53. Involvement of notified bodies in conformity assessment procedures 54. Clinical evaluation consultation procedure for certain class III and class IIb devices 55. Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices 56. Certificates of conformity 57. Electronic system on notified bodies and on certificates of conformity 58. Voluntary change of notified body 59. Derogation from the conformity assessment procedures 60. Certificate of free sale
66 www.gandlhealth.com Key Concepts Rules apply according to intended purpose: • Duration (continuous use) • Transient (<60 min) • Short term (<30 days) • Long term (>30 days) • Invasiveness • Invasive in a body orifice (stoma) • Surgically invasive • Implantable (hip replacement) • Non-Active/Active* Concept of Time • Application may be quick, but in situ for longer e.g. cream • Continuous use: uninterrupted actual use of the device for the intended purpose. • Where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device. Ref: MDR Annex VIII Chapter II 3.6 Article 51 Device Classification
Devices shall be divided into classes I, IIa, IIb and III, considering the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. In terms of invasiveness ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. 2.2. ‘Surgically invasive device’ means: (a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and (b) a device which produces penetration other than through a body orifice. 2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. Article 51 - Device Classification - Active Medical Device • Any medical device operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. • Any medical device operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.
68 www.gandlhealth.com High Risk Low Risk Classification Certification Required Notified Body Class III Full Certification Required Class IIb Full Certification Required Class IIa Full Certification Required Class Is (Sterile) Partial Certification Required Class Ir (Reusable) Partial Certification Required Class Im (Measurable) Partial Certification Required Class I Self-Certification Not Required Risk - Device Classification Article 51
More risk associated with the product the higher the classification • Class I - e.g. tongue depressor • Sterile • Measuring e.g. dosing spoon • Class IIA - e.g. blood pressure measuring • Class IIB - e.g. ventilators • Class III - e.g. heart valve Any dispute on classification between NB and company needs to be referred to competent authority.
70 www.gandlhealth.com There are 22 rules which may be applied to support the classification of a device. • Rules 1 - 4 – Non-invasive devices • Rules 5 - 8 – Invasive devices • Rules 9 - 13 – Active devices • (Rule 11 was changed, and now includes a rule that considers software to be a medical device. These requirements should be evaluated carefully to determine potential new classifications. If software can cause death or an irreversible deterioration of a person’s state of health, then it is in class III.) • Rules 14 - 22 – Special rules There are four new rules • Rule 19 – Nanomaterials • Rule 20 – All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation. • Rule 21 – Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body • Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device Annex VII, Chapter III Classification - Rules Article 51
https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf (October 2021) • Rule 14 - Devices incorporating, as an integral part, an ancillary medicinal product, and medicinal products derived from human blood or blood plasma – e.g. condom with spermicide, dressings incorporating an antimicrobial agent where that agent is intended to act on the wound (All class III) • Rule 15 - Devices used for contraception or prevention of sexually transmitted diseases – Condom without spermicide – Class IB, IUD – Class III • Rule 16 - Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices • Rule 17 - Devices to record X-ray diagnostic images • Rule 18 - Devices manufactured utilizing tissue or cells of human or animal origin or their derivatives Rule 19 - Devices incorporating or consisting of nanomaterial • Rule 20 - Invasive devices, intended to administer medicinal product by inhalation – e.g. spacer for inhaler • Rule 21 Devices composed of substances that are introduced via a body orifice or applied to the skin – eye drops for hydration, fat absorbers, salt water used as a nasal spray • Rule 22 Active therapeutic devices, with an incorporated diagnostic function – automated external defibrillators (AED), automated closed-loop insulin delivery system
72 www.gandlhealth.com Rule 6 Surgically Invasive– Transient Use IIa III III I IIb IIb IIb Interpreting Rules – Example Rule 6 Intended to administer medicines in a potentially hazardous manner Specifically, to control/diagnose/ monitor/correct a defect of heart or central circulatory system through direct contact For use in direct contact with central nervous system Supply energy/ ionising radiation Reusable surgical instrument Biological effect – mainly or wholly absorbed Article 51 Article 51
https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf According to Rule 6: Surgically Invasive devised with transient use are classified as Class IIa unless The device is specifically to control/diagnose/monitor/correct a defect of the heart or central circulatory system through direct contact – Class III Surgically invasive devices for use in direct contact with central nervous system are classified as a Class III device Surgically invasive reusable surgical instrument are classified as a class I device Surgically invasive instruments which supply energy/ ionising radiation , have a biological effect mainly or wholly absorbed by the patient, or are intended to administer medicines in a potentially hazardous manner are classified as a Class IIb device
Reclassification Process Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. MDR Article 51 3. EU Directives for Reclassification Commission can also decide by an implementing act to reclassify. Process can be used to avoid divergence of opinion • Reclassification of breast implants: http://eurlex.europa.eu/LexUriServ.do?uri=OJ:L:2003:028:0043:0044:en:PDF • Reclassification of hip, knee and shoulder joint replacements: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:210:0041:0043:en:PDF
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76 www.gandlhealth.com Demonstration of compliance of device with MDR Classification of device impacts conformity assessment route required Manufacturers must conduct a conformity assessment before placing their device on the market. Manufacturer secures services of an approved NB NB must follow clinical evaluation consultation procedure as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X for applicable devices Article 54 Clinical evaluation consultation procedure for certain class III and class IIb devices Article 52 Conformity Assessment Procedures Article 53 Involvement of notified bodies in conformity assessment procedures Article 51
https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/pdf Manufacturer demonstrates that devices comply with the requirements of the regulation. The classification of the medical device will have an impact on the conformity assessment route that the manufacturer should follow in order to affix the CE marking on the medical device. Manufacturers must conduct a conformity assessment before placing their device on the market. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. A notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment on specific devices.
78 www.gandlhealth.com NB required to upload certificates and other mandatory information as referenced in Article 54 Certificates of Conformity issued by NB to confirm manufacturer meets Article 52. CoC valid ≤ five years EUDAMED Article 57 Electronic system on notified bodies and on certificates of conformity Article 55 Mechanism for Scrutiny of Conformity Assessment of Certain Class III and Class IIb Devices Article 56 Certificates of Conformity
79 www.gandlhealth.com Any change in NB will need to be clearly detailed with agreements defined Document issued in an authorised Member State as evidence of conformity. Used for third country device registration processes. Article 60 Certificates of free sale (CFS) Article 58 Voluntary Change of NB Article 59 Derogation from the conformity assessment procedures Competent authority may authorise placing on market of an “unapproved” medical device in the case of an urgent medical need
80 www.gandlhealth.com Part A -Annex XIV – Clinical Evaluation and Post Market Clinical Follow up (PMCF) Annex XV – Clinical Investigation Chapter VI Clinical Evaluation and Clinical Investigation Article 61 - 82
Articles of Chapter VI 61. Clinical evaluation 62. General requirements regarding clinical investigations conducted to demonstrate conformity of devices Involvement of notified bodies in conformity assessment procedures 63. Informed Consent 64. Clinical investigations on incapacitated subjects 65. Clinical investigations on minors 66. Clinical investigations on pregnant or breastfeeding women 67. Additional national measures 68. Clinical investigations in emergency situations 69. Damage compensation 70. Application for clinical investigations 71. Assessment by Member States 72. Conduct of a clinical investigation
Articles of Chapter VI 73. Electronic system on clinical investigations 74. Clinical investigations regarding devices bearing the CE marking 75. Substantial modifications to clinical investigations 76. Corrective measures to be taken by Member States and information exchange between Member States 77. Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 78. Coordinated assessment procedure for clinical investigations 79. Review of coordinated assessment procedure 80. Recording and reporting of adverse events that occur during clinical investigations 81. Implementing acts 82. Requirements regarding other clinical investigations
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84 www.gandlhealth.com Medical device product development lifecycle •Is it a medical device? •Intended use •Initial risk analysis •Product definition and intellectual property •Commercial plan •Potential markets and routes •Draft regulatory strategy •Personnel /resource requirements •Concept development •Prototype analysis •Initial testing •Design file and risk analysis •User feedback •Commercial and market strategy •Regulatory strategy •Quality management system •Project plan •User feedback •Manufacturing process •Design verification and validation •Risk management •Draft technical documentation •Regulatory strategy •Product claims and branding •Regulatory requirements •Market plan/forecast •Process validation •Clinical validation •Product claims •Final labelling •Regulatory submission •Product reimbursement •EU CE marking and UKCA marking •Global market access certification •Regulatory approval •Sales and clinician training •Launch product to market •Individual country reimbursement approval •Post market surveillance •Post market clinical follow-up •Complaints and adverse events •Product improvements •Process improvements •External body audits •Market performance •New market launches Concept Initial Evaluation of possible development of a commercial product Planning Definition of design input based on customer needs and technical requirements Design Development of product design and of manufacturing process, verification and validation Validation Final validation of manufacturing process and preparation for product introduction Launch Product Launch Post Market Post market surveillance
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86 www.gandlhealth.com Clinical Evaluation Report (CER) The CER must include: • a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied • a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under MDR • a consideration of currently available alternative treatment options for that purpose, if any. Clinical Evaluation Article 61 - 82
Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data (labelling) as referred to in Annex III. The level of clinical evidence required should be appropriate to the device and its intended performance. A clinical evaluation is required for all devices (Follow Annex IV Part A and MEDDEV). This is a new requirement and one of the primary reasons that manufacturers have struggled to achieve MD certification, significant number of devices do not have any clinical data from studies to demonstrate safety and efficacy. Mostly reliant on absence of event reports or minimal adverse events/failures. The requirement for a Clinical Evaluation Report (CER) is not new - MDD Essential requirement 6a.
88 www.gandlhealth.com Clinical Evaluation Clinical Evaluation Article 61 - 82 The ability of a device to achieve its intended purpose The ability of a device to achieve its intended purpose, thereby leading to a clinical benefit The positive impact of a device n the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcomes Purpose Clinical Purpose Clinical Benefit
Clinical investigation as required under the MDR are conducted as part of the clinical evaluation for conformity assessment which, should be designed, authorised, conducted, recorded and reported in accordance with article 62 - 81 of the regulation. Clinical investigations help establish and verify performance, identify clinical benefits, clinical safety and any potential undesirable side effects. Article 74 provides requirements for some clinical investigations. In addition to the requirements of the MDR manufacturers need to incorporate a national requirement of the member state in which the study is conducted. Annex 1 covers conformity with relevant general safety and performance requirements in line with the intended use of the product. This evaluation will consider any undesirable side effects and evaluate the benefit risk ratio, the classification of the product will determine the level of clinical evidence required however it must be notes that all classifications of devices will need to present a clinical evaluation and a subsequent experts clinical evaluation report. Stated more succinctly, the purpose of the clinical evaluation is to demonstrate, with objective and scientifically valid evidence, that the device does what it is supposed to do, achieves its intended clinical benefits (whether direct or indirect) and that the benefit-risk conclusion is acceptable in comparison to other available therapeutic or diagnostic options. *While the requirement for a CER is not new, the inputs and level of detail required under MDR are significantly more than those for MDD and many manufacturers haven’t made the necessary leap to adapt their processes to meet these.
90 www.gandlhealth.com The different rules on notifying the MHRA of a clinical investigation conducted in Great Britain (England, Wales and Scotland) and Northern Ireland: - Clinical investigations being conducted in Northern Ireland are required to align with EU rules for devices. Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) have been in force in Northern Ireland from 26 May 2021, and 26 May 2022 respectively in line with EU legalisation. The clinical investigations must meet these regulations and be submitted to the MHRA for assessment. Clinical investigations being conducted in Great Britain need to meet the requirements of the UK MDR 2002 and be submitted to the MHRA for assessment Clinical Evaluation – Great Britain and Northern Ireland
However, in the event that clinical investigations are conducted in both Great Britain and Northern Ireland submissions to the MHRA must be made in compliance with the EU MDR. By demonstrating compliance to the EU MDR regulations, it is deemed by the competent authority that the requirements of the UK MDR 2002 have been satisfied. Based on this a single application to the MHRA will be sufficient and will cover all sites in GB and NI. Under the EU regulations MDR and IVDR sponsors to be established to coordinate and act as point of contact for the health authorities withing either the EU or NI. However, there is an allowance for clinical studies to be conducted in line with the regulations and in conjunction with local legalisation. Based on this the MHRA can conduct the clinical investigation while not implementing this specific requirement provided the following conditions are meet: • The investigation or study must also be taking place in both Northern Ireland and Great Britain. • The investigation or study must not be taking place in an EU Member State. • The sponsor must be either established in or have a written agreement with a legal representative in Great Britain, who is responsible for ensuring compliance with the sponsor’s obligations in the MDR or IVDR. • The sponsor must establish a contact person in Northern Ireland for the clinical investigation or performance study, who will be the addressee for all communications with the sponsor provided for in MDR or IVDR. Any communication with that contact person is deemed to be communication with the sponsor. As discussed in slide 19 on the UKCA mark either the manufacturer or the responsible person will be assigned to coordinate the submission and act as the point of contact with the MHRA. All other requirements of the MDR and IVDR are still applicable.
92 www.gandlhealth.com Annex XIV Part B – Post Market Clinical Follow UP (PMCF) PMCF is a continuous process that updates the clinical evaluation and the proactive collection and evaluation of clinical data PMCF Plan objectives: • Confirm safety and performance • Identify and monitor side effects • Identify and analysis emergent risks • Benefit –risk ratio • Identify misuse/off label use PMCF Plan content: • Confirm safety and performance • Identify and monitor side effects • Identify and analysis emergent risks • Benefit –risk ratio • Identify misuse/off label use PMCF Plan Analyse findings PMCF Report Update clinical evaluation and risk Implement CAPAs management if needed
Post-Market Clinical Follow-up is an important component of Post-Market Surveillance (PMS) that applies to almost all medical devices* under the EU MDR. It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According the MDR Annex XIV Part B, Post Market Clinical Follow up should run on a continuous basis throughout the entire lifetime of a device. * in reality, there are few cases where PMCFs have been deemed to be redundant – however, it is still early days of assessments by NB so there isn’t a consensus yet. PMCF has been an important component of medical device regulatory frameworks since the introduction of the Medical Device Directive (MDD). However, the introduction of the MDR has elevated the importance of PMCF and, with very limited exceptions, it now applies to all medical devices regardless of risk class. It is vital that medical device manufacturers have a solid understanding of PMCF requirements under the EU MDR regulatory framework. The design of PMCF studies and surveys should be documented in a PMCF Plan and results must be collated in a PMCF Report that forms part of the Clinical Evaluation Report (CER) for the device.
94 www.gandlhealth.com Clinical Investigations Article 81 MDR Annex XV, Clinical Investigations: Chapter 1 - General Requirements; Chapter 2 - Documentation Regarding the Application for Clinical Investigation; Chapter 3 - Other Obligations of the Sponsor. md_guidance_meddevs_0.pdf (europa.eu)
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96 www.gandlhealth.com Chapter VII Post – Market Surveillance, Vigilance and Market Surveillance Article 83 - 100 Section 2 - Vigilance Section 1 – Post – Market Surveillance (PMS) Section 3 – Market Surveillance Annex III – Technical Documentation on PMS
Section 1 – Post-market surveillance Article 83 – Post-market surveillance system of the manufacturer Article 84 – Post-market surveillance plan Article 85 – Post-market surveillance report Article 86 – Periodic safety update report Section 2 – Vigilance Article 87 – Reporting of serious incidents and field safety corrective actions Article 88 – Trend reporting Article 89 – Analysis of serious incidents and field safety corrective actions Article 90 – Analysis of vigilance data Article 91 – Implementing acts Article 92 – Electronic system on vigilance and on post-market surveillance Section 3 – Market surveillance Article 93 – Market surveillance activities Article 94 – Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Article 95 – Procedure for dealing with devices presenting an unacceptable risk to health and safety Article 96 – Procedure for evaluating national measures at Union level Article 97 – Other non-compliance Article 98 – Preventive health protection measures Article 99 – Good administrative practice Article 100 – Electronic system on market surveillance
98 www.gandlhealth.com What is Post market surveillance? • To keep up to date a systematic procedure to proactively collect and review experience gained from devices placed on the market • Collect from activities carried out by manufacturers in cooperation with other economic operators • For the purpose of identifying any need to immediately apply any necessary corrective or preventive actions PMS System • Requirement for all manufacturers • Appropriate for the device and risk class • Active, systematic process: • Gathering quality, performance and safety data • Analysing • Reaching conclusions • Determining, implementing, monitoring CAPAs • Feedback into other processes Continuous process through the product life cycle Reactive PMS Market Feedback Customer complaints Proactive PMS Post-Market Surveillance Clinical Evaluation Risk Analysis Design Changes Post Market Surveillance
Post-market surveillance is a process of proactively collecting and analyzing experience gained from devices on the market. This surveillance is crucial because some risks may appear only after use, in transport, during storage, or while cleaning. Therefore, we can say that PMS serves to identify problems in the design and/or use of the device after it is placed on the market. Requirements for PMS can be found in the following regulation and standards: •Article 15 – Person responsible for regulatory requirements •Article 83 – Post-market surveillance system for the manufacturer •Article 84 – Post-market surveillance plan •Article 85 – Post-market surveillance report •Article 86 – Periodic safety update report •Annex 3 – Technical documentation for post-market surveillance system
100 www.gandlhealth.com In the context of Medical Devices vigilance is: “system for the notification and evaluation of incidents and field safety corrective actions(FSCA) involving MEDICAL DEVICEs” (ref. MEDDEV 2.12-1, rev. 8) Any serious incident involving devices made available on the Union market, except expected side-effects: • Clearly documented in the product information and • Quantified in the technical documentation and • Subject to trend reporting Any field safety corrective action in respect of devices made available on the Union market, including: • FSCAs outside the EU if relevant to the CE marked device Vigilance What is Vigilance What must be reported