Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
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Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
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Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
- 1. Quality Management System and Regulatory Workshop Innovation Agency 6th December 2018
- 2. Quality Management System and Regulatory Workshop Agenda ⢠Regulatory compliance and effectiveness with global regulatory agencies. ⢠CE Marking for Europe ⢠The Medicines & Healthcare products Regulatory Agency (MHRA) explained. ⢠Supporting Manufacturers in Working with Competent Authorities.
- 4. Experience in over 331 Cities and 39 Countries.
- 5. Industry Focus + Services About Maetrics Services Across Industries BIOTECHNOLOGY MEDICAL DEVICES PHARMACEUTICALS DIAGNOSTICS TrainingMergers & Acquisitions Integration & Deal Support Data Analysis & Reporting Regulatory Compliance & Affairs Quality Management Systems Validation Performance Improvement Product Life Cycle Risk Management Clinical Evaluation Reports (CER) Information Technology Organizational Change Management
- 7. Quality Management System and Regulatory Workshop Regulatory Compliance: A Global Perspective
- 8. Quality Management System and Regulatory Workshop Regulatory Compliance: A Global Perspective
- 9. Quality Management System and Regulatory Workshop Requirements for Global Regulatory Compliance 1. Essential Principles of Safety and Performance 2. Quality Management System Most regulatory frameworks for medical devices require the following two elements:
- 10. Quality Management System and Regulatory Workshop Achieving Global Regulatory Compliance
- 11. Quality Management System and Regulatory Workshop Demonstrate Safety & Efficacy In-house testing and analysis Contract test laboratories Clinical Research Organisations Horizontal standards Vertical standards Bespoke test methods Regulatory Guidelines Performance testing Risk Management Biocompatibility Electrical Safety Sterility Packaging Integrity Shelf Life Labelling Usability Clinical testing
- 12. Quality Management System and Regulatory Workshop Demonstrate Safety & Efficacy E.g. Summary Technical Documentation (STED), Technical File, Medical Device File, Design DossierâŚ.
- 13. Quality Management System and Regulatory Workshop Quality Management System Implementation Horizontal standards E.g. ISO 13485:2016, ISO 9001:2015 Certification Bodies Auditing Organisations
- 14. Quality Management System and Regulatory Workshop Quality Management System Implementation Management Responsibility Resource Management Product Reaslisation Measurement, Analysis & Improvement Customers, Regulatory Authorities & Other interested parties Requirements Customers, Regulatory Authorities & Other interested parties Feedback Product OUTPUT
- 15. Quality Management System and Regulatory Workshop Whoâs Who? Competent Authorities Manufacturer Importer Distributor Authorised Representative Market Authorisation Holder Sponsor Certification Bodies Notified Bodies Auditing Organisations Accredited Test Houses
- 16. Quality Management System and Regulatory Workshop Where do they fit? Competent Authority Manufacturer Competent Authority Manufacturer Independent Certification Body Competent Authority Manufacturer Competent Authority Manufacturer Independent Certification Body âAuthorised Representativeâ âAuthorised Representativeâ
- 17. Quality Management System and Regulatory Workshop Risk-Based Conformity Assessment Degree Of Competent Authority / Independent Organisation Assessment Product Risk Level LOW RISK HIGH RISK
- 19. Quality Management System and Regulatory Workshop The European Regulatory Framework Active Implantable Medical Device Directive (AIMDD) â 90/385/EEC . Introduced July 1990 Medical Device Directive (MDD) â 93/42/EEC. Introduced June 1993 In-Vitro Diagnostic Medical Device Directive (IVDMD) â 98/79/EC. Introduced October 1998 Medical Device Regulations (MDR) 2017/745 Introduced May 2017 In-Vitro Diagnostic Regulations (IVDR) Introduced May 2017
- 20. Quality Management System and Regulatory Workshop The European Regulatory Framework Competent Authorities Notified Bodies Manufacturers etc. European Commission NEW!!! MDR 2017/745 IVDR 2017/746
- 21. Quality Management System and Regulatory Workshop Regulatory Compliance: The European System Competent Authorities Notified Bodies Manufacturers etc. ISO 13485:2016 Essential Requirements (ER) General Safety & Performance Requirements (GSPR)
- 22. Quality Management System and Regulatory Workshop Regulatory Compliance: The European System Competent Authorities Notified Bodies Manufacturers etc.
- 23. Quality Management System and Regulatory Workshop Regulatory Compliance: The European System Competent Authorities Notified Bodies Manufacturers etc.
- 24. Quality Management System and Regulatory Workshop Risk-Based Conformity Assessment in Europe Degree Of Competent Authority / Independent Organisation Assessment Product Risk Level LOW RISK HIGH RISK QMS assessment Assess sterility & measuring Review of Technical Documentation Examination of Technical Documentation Class III Class IIb Class IIa Class I
- 25. Quality Management System and Regulatory Workshop CE Marking: Process Overview Technical File/Design Dossier â˘Intended use â˘Risk management â˘Design â˘Manufacture â˘Product & Process Validation â˘Labelling, IFU & Packaging â˘Clinical PMS â˘Declaration of conformity Medical device Product Classification Class I Class Is, Im Class IIa, IIb Class III Notified Body 0088 Quality Management System (ISO 13485:2016) Market medical device New Product Development / Design (Project file) MHRA MHRA
- 26. Quality Management System and Regulatory Workshop CE Marking: High level process flow *Class I (non measuring, non sterile) self-declared. Requires registration with Competent Authority
- 27. The MHRA
- 28. Quality Management System and Regulatory Workshop Regulatory Compliance: The European System Competent Authorities Notified Bodies Manufacturers etc.
- 29. Quality Management System and Regulatory Workshop The MHRA: A Brief History Scientific & Technical Branch Medical Devices Directorate Medical Devices Agency MHRA
- 30. Advice & Guidance Registration Adverse Incidents Field Safety Corrective Actions Liaise with Stakeholder Groups Clinical Investigations Notified Bodies Non-CE Marked devices for humanitarian use Quality Management System and Regulatory Workshop The MHRA
- 31. Clinical & Development Manufacturing Distribution Sales & Marketing Our Services Across Industries REGULATORY COMPLIANCE ⢠Global regulatory strategies (FDA/EU/Other) ⢠Compliance audits & gap analyses ⢠Mock inspections ⢠FDA warning letter responses & remediation ⢠Facilities operations review CE Mark QUALITY MANAGEMENT SYSTEMS ⢠Quality systems auditing ⢠Pre-certification auditing ⢠ISO certification readiness ⢠Batch records documentation ⢠Master record & technical file remediation ⢠CAPA services ⢠Vendor/supplier audits REGULATORY AFFAIRS ⢠US Class III medical device submissions; EU Class III MDD submissions (change amendments, design dossiers) ⢠Independent regulatory guidance to product development teams ⢠Technical file remediation Complaint handling & recalls CLINICAL EVALUATION REPORTS (CERS) ⢠CERs strategies & guidance against Annex X MEDDEV 2.7/1 ⢠Data/literature protocol & search ⢠Full product CERs or updates to CERs post review (medical writing) ⢠Internal CER process improvement VALIDATION ⢠Validation master plan ⢠Process & product validation ⢠Computer systems validation ⢠Equipment validation ⢠Special processes & procedures ⢠Test method validation PRODUCT LIFE CYCLE MANAGEMENT ⢠Product risk management framework & risk assessment ⢠Risk controls to drive results in acceptance, mitigation, and avoidance ⢠Design verification & activities PERFORMANCE IMPROVEMENT ⢠Kaizen event planning ⢠Mfg process improvement ⢠Operations/Asset utilization (Mfg, Inventory, DC & Transportation) ⢠Value Stream mapping & process standardization & simplification M&A INTEGRATION & DEAL SUPPORT ⢠Due diligence ⢠Regulatory compliance ⢠Quality & Operational Integration DATA ANALYTICS & REPORTING ⢠Performance analytics (Vision Tool) ⢠Risk mitigation & compliance awareness TRAINING ⢠Portfolio of specialized courses in regulatory, quality, risk management, sterilization and contamination control ORGANIZATIONAL CHANGE MGMT ⢠Due diligence ⢠Regulatory compliance ⢠Quality & Operational Integration INFORMATION TECHNOLOGY ⢠Strategy & policy ⢠510(k) device software development and testing ⢠Data migration validation
- 32. 32 THANK YOU Ed Ball, Senior Associate eball@maetrics.com | +44 758 406 3083 Office information@maetrics.com | +44 115 921 6200 www.maetrics.com
- 33. MDSAP Audit Criteria ISO 13485: 2016 TGA ANVISA Health Canada FDA Specific Requirements MDSAP Single Comprehensive Audit Model PMDA Performed by auditing organisations not regulatory authorities. Back to Slide 10
- 34. Understanding the EU MDR Change Multiple Reason for the Change ⢠Inconsistent Notified Body services ⢠Different EU countries interpret and implement the Directives in different ways ⢠Rules failed to keep pace with technical and scientific progress ⢠Patients and care providers do not have access to sufficient evidence about devicesâ safety and clinical performance ⢠Not always possible to track devices back to their original suppliers 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2008: Effort initiated to recast of the medical device directive âRecastâ put on hold and process evolved into the EU MDR to address public concerns and strengthen regulatory system 2010: High-profile adverse events publicity in the industry Notified Body British Medical Journal undercover investigation 2010 Poly Implant Prostheses (PIP) Breast Implants Scandal Arrest of PIP founder, Jean-Claude Mas A faulty PIP implant* 2010 Metal on Metal Scandal August 2010, DePuy issued a voluntary recall of two hip implant devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices 2017 EU MDR published Updates also needed due to: Back to Slide 18
- 35. Understanding the Reason for the Change Restoring Confidence through Four Areas of Focus Notified Bodies ⢠Level playing field ⢠Better oversight of Notified Bodies ⢠Joint inspection of Notified Bodies Unannounced audits by Notified Bodies Market Surveillance ⢠Strengthened post-market surveillance ⢠Traceability/UDI ⢠Stricter requirements for Post-Market Clinical Follow up Coordination on Vigilance ⢠Increased coordination of vigilance among Member States and Regulators Communication & Transparency ⢠Increased transparency through the EUDAMED database ⢠Increased scrutiny of high risk devices The changes were made to restore confidence in the European Union regulatory system with changes in the following four areas: Back to Slide 18
- 36. Understanding the EU MDR Change New and Changed Requirements in the EU MDR This diagram shows the key changes in the new Medical Device Regulations Back to Slide 18
- 37. MDR Transition Timelines 2017 [May 25] EU MDR Entered into Force 2017 2018 2019 2020 2024 New or Renewing Devices must have MDR certs MDD Certs Issued Existing MDD Certs Valid May 26, 2020 Date of Application May 2024 Any Remaining MDD Certs Voided MDR Certs IssuedDesignation 2017 [Nov 26] Notified Bodies may apply for MDR Designation ⢠MDD certificates are valid after 26th May 2020 until they expire or up to maximum of 4 years, 26th May 2024 (provided there are no significant changes to intended use). ⢠A further 1 year of putting these devices into service allows devices to remain on market until 26th May 2025 May 2025 MDD Devices must be no longer sold 2025 ⢠Class I devices required to comply ⢠MDR PMS and Economic operator requirements apply to all devices Back to Slide 18
Editor's Notes
- Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies. With over 30 years of service as a compliance consulting firm, Maetrics has developed and executed pragmatic solutions for the majority of the worldâs leading biotechnology, pharmaceutical, medical device, and diagnostic products organizations.
- With experience across the industry, our consultants deliver strategies in a broad spectrum of areas that include but are not limited to the following services: Comprehensive remediation strategies FDA mock inspections for GMP, GLP and GCP environments CAPA handling and closure Preparation of responses to FDA 483, citations, and warning letters Compliance audits, assessments, and gap analyses Validation audits Regulatory strategy development Complaint handling and recalls Supply-chain audits Medical device audits for 21 CFR Parts 820 (QSR and QSIT audits) Pharmaceutical audits for 21 CFR Parts 210/211, 110, and 107/108 ISO 9001/14001 Computer systems audits and Part 11 assessments and remediation
- There are about 195 countries in the world (193 being in the UN). Iâm not going to try and give you a masterclass in the regulatory pathways for all of these countries. Besides some of them donât even have regulations that cover medical devices and some donât have medical device specific regulations. I will give you an overview of the pathway for the majority of the regulated markets, the key elements and the organisations with whom you will need to deal with.
- Here are some of the major areas for medical device regulation now and in the futureâŚ. Australia, Therapeutic Goods Administration (TGA) Brazil, National Health Surveillance Agency (ANVISA) Canada, Health Canada China, China Food and Drug Administration (CFDA) European Union, European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Japan, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, Ministry of Health, Labour and Welfare (MHLW) Russia, Russian Ministry of Health â part of the Eurasian Economic Union (EAEU)âŚworking on a single system for 2022 Singapore, Health Sciences Authority â part of the Association of Southeast Asian Nations, (ASEAN) whose AMDD will be implemented by Jan 2020 South Korea, Ministry of Food and Drug Safety USA, US Food and Drug Administration (FDA) Some of the above, and especially the less mature regulatory frameworks around the globe allow you to leverage EU and US, and to certain extent Canadian, conformity assessments to provide a passport to other global markets. The Eurasian Economic Union (EAEU): Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia The Association of Southeast Asian Nations, (ASEAN), was established on 8 August 1967. Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam IMDRF: The IMDRF is a voluntary group of medical device regulators from around the world that was created in 2011: Replace the Global Harmonization Task Force on Medical Devices (GHTF) and build on its strong foundations and previous work to accelerate international medical device regulatory harmonization and convergence Members: Australia, Therapeutic Goods Administration (TGA) Brazil, National Health Surveillance Agency (ANVISA) Canada, Health Canada China, China Food and Drug Administration (CFDA) European Union, European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Japan, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, Ministry of Health, Labour and Welfare (MHLW) Russia, Russian Ministry of Health Singapore, Health Sciences Authority South Korea, Ministry of Food and Drug Safety USA, US Food and Drug Administration (FDA) WHO are an official observer.
- The IMDRF are working to accelerate international medical device regulatory harmonization and convergence to ensure that regulatory requirements across the global are not inconsistent. E.g. the MDSAP. Harmonised standards, recognised consensus standards â those standards that the regulatory authorities recognise as suitable methods, processes or requirements to demonstrate safe and effective products. Horizontal standards (methods, processes, quality systems), vertical standards (specific to product groups, specific products, materials etc.), common specifications, pharmacopoeia (specifications for materials etc., test methods),
- These essential principles are well established (e.g. ERs in MDD, GHTF document in 2005) but the regulatory landscape is shifting to ensure that more clinical and real world data is available to demonstrate clinical efficacy and safety. Therefore there is more emphasis on clinical investigation data, usability study data, thorough risk management and post market clinical follow ups than there has been before. There is a steady move away from reliance solely on laboratory test data and comparisons with predicate devices, more so for higher risk devices. This is evident in the new EU MDR. And is part of the wider discussion within the recent #Implant Files news reports.
- Most regulatory authorities are moving their requirements for quality management systems towards ISO 13485:2016. MDSAP is based on ISO 13485:2016. The EU expect ISO 13485:2016 certified quality management systems. Indiaâs new regulations are based around ISO 13485:2003 / EN ISO 13485:2012 with some of the 2016 additions included. South Korea are heading in the direction of using ISO 13485:2016 as their framework for quality management systems rather than their traditional GMP requirements. ISO 13485:2016 transition period ends at the end of Feb 2019.
- Essentially a quality management system creates framework for how your system operates in order to achieve its identified objectives. It defines the standards you work to, the processes followed, and the people, actions and documents to be used to carry out work in a consistent manner. Very simply, it is a set of processes that interact with one another to ultimately generate an output (i.e. a product). ISO 13485:2016 defines the requirements for the processes that must be in place, and what the processes must include. These processes cover your âcontrolâ over materials, suppliers, manufacturing environments, product designs, measuring equipment, manufacturing processes, personnel competence and computer systems.
- The applications for device authorisation (or approval, or clearance etc) requires a domestic organisation to be the contact point for the Competent Authority. So if you are not based in that country or region, you are likely going to need a locally based partner organisation to work with. Distributor natural or legal person in the supply chain Importer natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed who, on his own behalf, furthers the availability of a medical device to the end user Manufacturer natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) Authorized Representative Represents the Legal Manufacturer in EU, point of contact for vigilance and Competent Authority communication Others: importer license holder Marketing Authorization Holder (Japan) Australian importers (Sponsors) Device marketing authorization shall be requested to ANVISA by the domestic manufacturer or importer (legal representative) formally established in Brazil.
- Authorized Representative Represents the Legal Manufacturer in local region, point of contact for vigilance and Competent Authority communication Others: importer license holder Marketing Authorization Holder (Japan) Australian importers (Sponsors) Device marketing authorization shall be requested to ANVISA by the domestic manufacturer or importer (legal representative) formally established in Brazil.
- The lower the risk to patient the lower the risk class and the less regulatory burden. Risk classification is mainly for Competent Authorities to prioritise their work based on product risk. The requirements for you as a manufacturer are still the same but the likelihood is that it will take less effort and time to demonstrate the safety and efficacy of a low risk medical device than it would a high risk medical device.
- Introduction of Medical Device Directives in order â Active Implantable MDD introduced for the high risk devices first in 1990. Followed by MDD for general medium/low risk devices in 1993. Followed by IVDMD for low risk devices in 1998. Amendment 2007/47/EC applies to all 3 Directives. New regulations came in during 2017. MDR replaces MDD and AIMDD. MDR has a 3 year transition (2020) and IVDR a 5 year transition (2022).
- Manufacturers have to demonstrate that devices are safe and effective, and have a quality management system.
- Here are a selection of EU Notified Bodies. There are currently about 55 registered for the current directives, that number is expected to drop for designation under the new MDR. Notified Bodies review technical documentation. They are also certification bodies for quality management systems such as EN ISO 13485:2016 and ISO 9001:2015. At Maetrics we have a number of staff that have held key roles within Notified Bodies, which puts us in a good position to ensure the strategies and solutions that we provide to our clients are robust and compliant.
- Here are some of the EU Competent Authorities
- The lower the risk to patient the lower the risk class and the less regulatory burden. Risk classification is mainly for Competent Authorities to prioritise their work based on product risk. The requirements for you as a manufacturer are still the same but the likelihood is that it will take less effort and time to demonstrate the safety and efficacy of a low risk medical device than it would a high risk medical device.
- Class Is, Im, IIa and IIb â exclude Design requirements The new regulations also add in a pathway for Class I reusable instruments (e.g. surgical instruments). Technical Documentation under the MDR is to contain: DEVICE DESCRIPTION Device description and specification Reference to previous and similar generations of the device INFORMATION SUPPLIED BY THE MANUFACTURER AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES DESIGN AND MANUFACTURING INFORMATION GENERAL SAFETY AND PERFORMANCE REQUIREMENTS RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT PRODUCT VERIFICATION AND VALIDATION Pre-clinical and clinical data Additional information in specific cases TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE EU DECLARATION OF CONFORMITY
- Here are some of the EU Competent Authorities
- Scientific and Technical Branch of DoH was established in the late 1960s During the 1980s, the STB became part of the NHS Procurement Directorate, which was later split into the NHS Supplies Authority and the Medical Devices Directorate (MDD) MDD in effect became the Medical Devices Agency in 1994 Medical Devices Agency then merged with its medicines counterpart (MCA) in 2003 to become the MHRA.
- The MHRA is still split into Medicines and Medical Devices functions, with a number of shared services. The devices functions are funded by Dept of Health. They have recently moved to Canary Wharf, from their previous location on Buckingham Palace Road (before that in Vauxhall, Elephant & Castle and Russell Square). For devices, their main role covers: Manage registration of Class I medical device manufacturers. Oversee the performance of the UK-based Notified Bodies. Manage the UK adverse incident database. Investigate serious adverse incidents occurring in the UK. Monitor the progress of manufacturer-led Field Safety Corrective Actions. Approval of Clinical Investigations. Also, approves applications on humanitarian grounds to use certain medical devices in the UK not carrying a CE marking
- At Maetrics we have experience in all elements of the product life cycle⌠Product development / product verification activities Developing regulatory strategies, classifying devices Working with Notified Bodies & Competent Authorities Developing technical documentation and supporting regulatory submissions Risk Management activities Clinical Evaluation report writing Implementing and improving quality management systems Validation activities Auditing â gap assessments, internal audits, supplier audits, mock-inspections Supporting complaint investigations and field safety corrective actions Training
- It is important to understand what led to these changes. The European Commission had initiated efforts to ârecastâ the Medical Device directives in 2008. The original directives had been established in 1990 and 1993, and there were a variety of reasons why they needed to be updated, as shown in the gray box. Starting in 2010 there were several high profile scandals, including an issue with Poly implant Prothese (PIP) silicone breast implants, where the founder was arrested, and concerns from a metal on metal scandal related to hip devices involved in a DePuy recall. There was also an also undercover investigation by a British Medical journal that uncovered concerns regarding notified bodies.
- A main reason for the changes is to restore confidence in the EU regulatory system. This is being accomplished with these four areas of focus.
- The items highlighted in solid and dashed red lines in this diagram represent new or changed requirements in the new EU MDR, as compared to the current Medical Device Directives, AIMD and MDD. A new database, EUDAMED, is being established, and will be utilized by the Manufacturer, Importers, Distributors, Authorized Representatives, Notified bodies and Competent Authorities. And for the first time, the general public will have direct access to certain information. Notified Bodies will now require additional requirements to be met for Clinical Evaluations, and will also review additional proactive post-market surveillance information, including Post-Market Clinical Follow-Up plans and reports (PMCF), and Periodic Safety Update Reports (PSUR) on an on-going basis. There is a new role required of both the Manufacturer and the Authorized Representative â both must have access to a âPerson Responsible for Regulatory Complianceâ There is a new concept of âEconomic Operatorsâ â which is meant to identify entities with an economic interest in the device. The Manufacture, Importer, Distributor and Authorized Representative are all now considered Economic Operators, and must comply with requirements pertaining to Economic Operators. Requirements for the supply chain are specified in the EU MDR for the first time, and are the responsibility of the Manufacturer. This is similar to expectations by the FDA in the US regulations, and in the ISO 13485 standards. The EU MDR specifies requirements for Importers and Distributors, and indicates that each Importer and Distributor must register and be in compliance to the applicable regulations. This will be new for many companies that serve the Medical Device industry. Medical Devices will be required to have Unique Device Identification (UDI). This is similar to the requirement by the FDA in the United States, but it is not yet known if it will be implemented the same way as in the US. The EU MDR establishes a new Medical Device Coordination Group (MDCG), and describes how the MDCG may utilize Expert Panels, for the approval of Medical Devices. This is a new concept being introduced, and it is not yet fully clear how this will be implemented. Manufacturers will submit devices to Notified Bodies for review, and the Notified Bodies are responsible for presenting the devices to the MDCG for final approval.
- The new regulation entered into force and became law in May of 2017. There is a three year transition period. Notified bodies are in the process of being re-designated. Once that occurs they will be able to issue MDR certificates. In the meantime they still may issue certificates under the MDD requirements, and MDD certificates will be valid through May 2024, as long as there isnât a significant change to the device. There is much discussion regarding how âsignificant changeâ will be defined.