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102 www.gandlhealth.com Market Surveillance Articles 93 - 100 Preventive health protection measures 98 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance 94 Electronic system on market surveillance 100 Good administrative practice 99 97 Other non-compliance Procedure for dealing with devices presenting an unacceptable risk to health and safety 95 Procedure for evaluating national measures at union level Market Surveillance Activities 93 9695
The competent authorities are required to perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints. These checks are conducted according to schedules set at CA level or where, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device presents a risk , the relevant economic operators shall cooperate with the competent authorities. Where a CA finds a device to be presenting a risk or be out of compliance, they can insist that the device be remediated in all Member States and notify all CAs, failure to remediate can lead to mandatory recalls of the product etc. One CA may disagree with another’s decision to impose sanctions on a product, Commission will arbitrate in those situations If there is non-compliance without serios risk to health, the product must still be brought into compliance but less likely to be recalled. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the outcomes of assessments, the assessment planning etc. Most information will be available to the public but where the disclosure of information might impair ongoing market surveillance, this information will be kept private.
104 www.gandlhealth.com 103 105 102 107 Competent authorities Support by the Commission Tasks of the MDCG Provision of scientific, technical and clinical opinions and advice 108 106 104 101 Medical Device Coordination Group (MDCG) Cooperation Device registers and data banks Conflict of interests Chapter VIII Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers Articles 101 - 108
The Member States are required to designate the competent authority or authorities responsible for the implementation of this Regulation. These CAs are obligated to cooperate with each other and with the Commission. Medical Device Coordination Group (MDCG), is an expert committee, composed of persons designated by the Member States (MS) based on their role and expertise in the field of medical devices to provide advice to the Commission with the aim of a harmonised implementation of the Regulation. Under the regulation, the Commission is required to support the functioning of the cooperation between national competent authorities, in particular, the organisation of exchanges of experience between the competent authorities and provide technical, scientific, and logistic support to the MDCG and its sub-groups. The Commission is required to support the provision of experts with the highest scientific competence to contribute to the development and maintenance of appropriate guidance and common specifications. The CAs, MDCG and expert groups may not have any financial or other interests that would provide for a conflict of interest. The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.
106 www.gandlhealth.com Chapter IX Confidentiality, data protection, funding and penalties Article 109 - 113 110 112 109 Levying of fees Funding of activities related to designation and monitoring of notified bodies 113 Penalties 111 Data protection Confidentiality
107 www.gandlhealth.com 118 Amendments to Regulation (EC) No 178/2002(Food) Amendments to Regulation (EC) No.1223/2009 (cosmetic products) 119 Amendment to Directive 2001/83/EC (Medical Products) 117 Committee procedure 114 116 Separate delegated acts for different delegated powers 115 Exercise of the delegation 121 Evaluation 120 Transitional provisions 122 Repeal 123 Entry into force and date of application Chapter X Final provisions Article 114 - 123
108 www.gandlhealth.com Legislation of Combination Products Devices MDD/MDR Drugs: 2001/83/EC ? Drug eluting stent Disposable insulin pen Sirolimus Insulin cartridge Reusable Insulin Pen Stent Article 117 Products should be regulated by either the device or medicine review process. Not both.
Action of the medicinal substance is principal (not ancillary) Devices for administration - single integral product non reusable (prefilled syringe) • Marketing Authorisation (MA) is required • Device part must comply with the relevant GSPRS • From May 2021 MA application must include: • CE certificate and /or Declaration of conformity OR • Notified Body opinion if not CE marked and if a CE certificate would be required • European Medicines Agency Guidance: Medical devices | European Medicines Agency (europa.eu) • EMA conducted a stakeholder meeting to discuss implementation (meeting see via website) • Guideline on Quality Requirements for Drug Device Combinations Current issues on life cycle management – what is a substantial change/variation guidance – currently no provisions • Pragmatic Solutions Needed for Lifecycle Management of Drug-Device Combinations (Guest Blog) (efpia.eu)
110 www.gandlhealth.com Annex I General Safety and Performance Requirements)* * Included as Part 4 of Technical Documentation
111 www.gandlhealth.com Annex II and Annex III Technical Documentation Articles 109 - 113 Annex III: Technical Documentation on post-Market Surveillance 6. Product verification and validation 5. Benefit-risk analysis and risk management 4. General safety and performance requirements 3. Design and manufacturing information 2. Information to be supplied by the manufacturer 1. Device description
112 www.gandlhealth.com 1. Device Description • Product name, description, • Intended purpose • Product identification including • basic UDI-DI • Principles of operation and mode of action • Why is it a medical device? • Risk classification? • Technical and material specification, description of key functional elements and any novel features • Overview of previous generations of the device • Overview of similar devices available in the EU or elsewhere 2. Information to be supplied by the manufacturer Complete set of: • Labels, including box/carton labels, product labels etc. • Package Inserts, where relevant • Brochures • Operating manuals • Instructions for Use (IFU) 211108_md-labelling_symbols-guidance_version-3_final_publication-1-1.pdf (medtecheurope.org) Technical Documentation
113 www.gandlhealth.com 3. Design and manufacturing information • Information to allow key design stages to be understood • Description of manufacturing processes • Manufacturing validations, monitoring and final product testing • Identification of all suppliers and sub-contractors undertaking design or manufacturing processes for the manufacturer 4. General safety and performance requirements 5. Benefit-risk analysis and risk management 6. Product verification and validation Annex III : MDR Requirements for Technical Documentation on Post-Market Surveillance Technical Documentation
The technical documentation on PMS to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.” • Includes PMS Plan, PMS Report (Article 85), PSUR (Article 86) and PMCF plan or justification for no-PMCF • Minimum requirements for PMS Plan - sources of information • Specific guidance on how to evaluate PMS data • Requirement (via Article 83) to update clinical evaluation, SSCP, design and manufacturing information and information for use on the basis of PMS output
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