How to survive the MDR

Transcription

1 How to survive the MDR Louis Habets LifetecZONe, 21 September

2 Agenda About the Medical Device Regulation Specific project! Highlights only showing where to find Discussion and Questions LifetecZONe, 21 September

3 Company - Xendo B.V leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices and healthcare. Headquarters in Leiden Affiliates in Berlin, London, Stockholm, Tokyo REGULATORY AFFAIRS PRODUCT DEVELOPMENT QUALIFICATION & VALIDATION PHARMACO VIGILANCE QUALITY MANAGEMENT & LEAN SIX SIGMA ENGINEERING & FACILITY SUPPORT LifetecZONe, 21 September

4 The MDD Transposition to the MDR a Specific Project the Medical Device Directive 93/42/EEC (MDD) the Medical Device Regulation EU 2017/745 (MDR) LifetecZONe, 21 September

5 The MDD Transposition to the MDR a Specific Project Transitieplan Relevant differences Risk Class Determination Conformity Assessment Procedure Top Management Awareness and Commitment Implementation Plan Assessment Partner Product Documentation Quality Management System Post Market Activities and Reporting LifetecZONe, 21 September

6 Deliverables of first Preparation MDD-MDR LifetecZONe, 21 September

7 Overview of the MDR Chapter Chapter I Chapter II Chapter III Chapter Title Scope & Definitions Making Available and Putting into Service, Obligations of Economic Operators Reprocessing CE-marking Free Movement Identification & Traceability Registration of Devices Registration of Economic Operators Summary of Safety and Clinical Performance European DataBank on Medical Devices Chapter IV Notified Bodies Chapter V Classification Conformity Assessment LifetecZONe, 21 September

8 Overview of the MDR Chapter Chapter VI Chapter VII Chapter VIII Chapter IX Chapter X Chapter Title Clinical Evaluation Clinical Investigation Post-Market Surveillance Vigilance Market Surveillance Cooperation between Member States, the Medical Devices Coordination Group, Expert Laboratories, Expert Panels and Device Registers Confidentiality Data Protection Funding Penalties Final Provisions LifetecZONe, 21 September

9 Transition to the MDR On the 5 th of May 2017 the Medical Device Regulation EU 2017/745 MDR was officially published. Replacing both the Medical Device Directive 93/42/EEC together with the Active Implantable Medical Device Directive 90/385/EEC. Directive vs Regulation; 28 European versions vs One Size Fits All but Delegated Acts Implementing Acts Three years: May 2020 LifetecZONe, 21 September

10 Transition to the MDR What are Delegated & Implementing Acts? Delegated Acts o defined as non-legislative acts o general application to supplement or amend certain non-essential elements of a legislative act o considered closer to actual law-making o may supplement or amend something of the original legislation In layman s terms: Delegated Acts should legislate upon the What o o o o represent an explicit decision by the EU legislators (Parliament and Council) grant the Commission power to act on a certain issue. clearly determined in the original legislation content is more likely to be politically sensitive LifetecZONe, 21 September

11 Transition to the MDR What are Delegated & Implementing Acts? Implementing Acts o used where uniform conditions for implementing legally binding Union Acts are required o considered to be inherently more procedural templates, procedures, deadlines o a pure, practical implementation of rules that already exist in the original legislation In layman s terms: Implementing Acts legislate upon the how implementation should take place LifetecZONe, 21 September

12 Chapter I: Scope and Definitions Medical Device definition (Article 2(1)) any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes LifetecZONe, 21 September

13 Chapter I: Scope and Definitions diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability investigation, replacement or modification of the anatomy or of a physiological or pathological process or state providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be Medical Devices: devices for the control or support of conception products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. LifetecZONe, 21 September

14 Chapter I: Scope and Definitions Product Scope expansion the definition of Medical Devices and Active Implantable Medical Devices is significantly expanded Included are: devices designed for the Purpose of Prediction of a Disease or other health condition. devices that do not have a Medical Intended Purpose Aesthetic Medical Devices ANNEX XVI: List of Groups of Products without an Intended Medical Purpose referred to in Art. 1(2) Examples: Non-corrective contact lenses Equipment for liposuction Equipment intended for brain stimulation LifetecZONe, 21 September

15 Chapter II: Making Available and Putting into Service of Devices As well as the obligations of Economic Operators, reprocessing, CE marking, free movement Economic Operator 1: Manufacturer: a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark general obligations of the Manufacturer (Article 10): o 16 points to consider Point 9: the Quality Management System shall ensure compliance with this Regulation LifetecZONe, 21 September

16 Chapter II: Making Available and Putting into Service of Devices The Quality Management System shall address at least the following aspects (a) a strategy for Regulatory Compliance (b) identification of applicable General Safety & Performance Requirements (c) responsibility of the management (d) Resource Management (e) Risk Management (f) Clinical Evaluation (g) Product Realisation (h) verification of the UDI assignments (i) Post-Market Surveillance System (j) communication with Competent Authorities, Notified Bodies, other Economic Operators, Customers and/or other Stakeholders (k) reporting of Serious Incidents and Field Safety Corrective Actions (l) Corrective & Preventive Actions (m)monitoring & Measurement of output, data analysis and product improvement. LifetecZONe, 21 September

17 Chapter II: Making Available and Putting into Service of Devices Economic Operators Economic Operator 2: Authorised Representative (Article 11 / 12): any natural or legal person established within the Union who has recieved and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer s behalf in relation to specified tasks with regard to the latter s obligations under this Regulation. Economic Operator 3: Importer (Article 13): any natural or legal person established within the Union that places a device from a third country on the Union market. Economic Operator 4: Distributor (Article 14) any natural or legal person in the Supply Chain, other than the Manufacturer or the Importer, that makes a device available on the market, up until the point of putting into service. LifetecZONe, 21 September

18 Chapter II: Making Available and Putting into Service of Devices Obligations of the Economic Operators Person Responsible for Regulatory Compliance (Article 15): 1. Manufacturers have within their organisation a Person Responsible for Regulatory Compliance who possesses the requisite expertise in the field of Medical Devices. 2. Micro and Small Enterprises are allowed to have such person permanently and continuously at their disposal. 3. responsible for ensuring that: (a) conformity of the devices, in accordance with the QMS, before releasing the device; (b) Technical Documentation and the Declaration of Conformity are drawn up and kept up-to-date; (c) Post-Market Surveillance obligations are complied with; (d) Reporting obligations are fulfilled; (e) Investigational Devices, carry the appropriate statement. LifetecZONe, 21 September

19 Chapter II: Making Available and Putting into Service of Devices Person Responsible for Regulatory Compliance (Article 15, cont.) 4. If a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility shall be stipulated in writing. 5. Independence: the Person Responsible for Regulatory Compliance shall suffer no disadvantage within the Manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. 6. Authorised Representatives shall have permanently and continuously at their disposal a Person Responsible for Regulatory Compliance who possesses the requisite expertise regarding the Regulatory Requirements for Medical Devices. Expertise demonstrated by either of the following qualifications: (a) university degree or equivalent, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in RA or in QMSs relating to Medical Devices; (b) 4 years of professional experience in RA or in QMSs relating to Medical Devices. LifetecZONe, 21 September

20 Chapter III: Identification and traceability Identification and Traceability of devices, registration of devices and of Economic Operators, Summary of Safety and Clinical Performance, European Databank on Medical Devices UDI Unique Device Identification enhanced ability of devices to be traced improved Control over the Distribution 26 th May 2027 Eudamed - European Databank on Medical Devices support transparency and strengthen Market Surveillance of Medical Devices. 25 th May , although o this deadline can be extended LifetecZONe, 21 September

21 Chapter IV: Notified Bodies a significant increase in the requirements for Notified Bodies will certainly lead to more intense scrutiny of compliance of the Manufacturer 1 article in the MDD articles 35-50of MDR read it for information, preparation and understanding LifetecZONe, 21 September

22 Chapter IV: Notified Bodies Article 35, Article 36, Article 37, Article 38, Article 39, Article 40, Article 41, Article 42, Article 43, Article 44, Article 45, Article 46, Article 47, Article 48, Article 49, Article 50, Authorities responsible for Notified Bodies Requirements relating to Notified Bodies Subsidiaries and subcontracting Application by Conformity Assessment bodies for designation Assessment of the application Nomination of experts for Joint Assessment of applications for notification Language Requirements Designation and notification procedure Identification Number and list of Notified Bodies Monitoring and re-assessment of Notified Bodies Review of Notified Body Assessment of Technical Documentation & Clinical Evaluation Documentation Changes to designations and notifications Challenge to the competence of Notified Bodies Peer review and exchange of experience between Authorities Responsible for Notified Bodies Coordination of Notified Bodies List of standard fees LifetecZONe, 21 September

23 Increasing risk Chapter V: Classification and Conformity Assessment Class III Pacemakers Heart Valves Implanted cerebral simulators Notified Body review and approval required Self Assessment Class IIb Class IIa Class I Condoms Lung Ventilators Bone Fixation plate Dental Implants Surgical Clamps Tracheotomy tubes Wheelchairs Spectacles Stethoscopes LifetecZONe, 21 September

24 Chapter V: Classification and Conformity Assessment Classification is based on risk, as set out in Annex VIII of the MDR. The assessment route depends on the classification of the device. Notified Bodies are independent certification bodies designated by a national Competent Authority. They perform Third Party Conformity Assessment activities including calibration, testing, certification and inspection. The risk class determines whether or not a Conformity Assessment is required (which is performed by a Notified Body). Notified Body Assessment and Approval is required for Class IIa, IIb and III Medical Devices. Manufacturers need to demonstrate that their Medical Devices meet the requirements in the MDR by carrying out a Conformity Assessment. Some Class I devices require Notified Body Assessment and Approval: measurement function sterile LifetecZONe, 21 September

25 Chapter VI: Clinical Evaluation and Clinical Investigations more stringent rules enforced to the requirements for Clinical Data. Clinical Evaluation: pre-market Clinical Evaluation Article 61 and Annex XIV, Part A (a) a Clinical Evaluation Plan (content is specified) (b) evaluation of Clinical data (c) a Clinical Evaluation Report (CER). Part B (a) Post Market Clinical Follow-up Plan (b) introducing the requirement for a Post Market Clinical Follow-up Evaluation Report. Clinical Investigation: Article 15 in the MDD on Clinical Investigation is replaced by the articles in the MDR. LifetecZONe, 21 September

26 Chapter VII: Post-Market Surveillance, Vigilance and Market Surveillance Post-Market Surveillance (PMS) all activities carried out by Manufacturers, in cooperation with other Economic Operators, to institute and keep up to date a systematic procedure to pro-actively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary PMS System (article 10) PMS Plan (article 84) PMS Report (article 85) PSUR (article 86) Periodic Safety Update Report Corrective or Preventive Actions LifetecZONe, 21 September

27 .Chapter VIII, IX, X Chapter VIII: Cooperation between Member States, Medical Device Coordination Group, Expert Laboratories, Expert Panels and Device Registers Chapter IX: Confidentiality, Data Protection, funding, penalties Chapter X: Final Provisions No Grandfathering all currently certified Medical Devices and Active Implantable Medical Devices must be re-certified in accordance with the new requirements. What does the no grandfathering rule imply? all devices which are currently on the market will need to comply with the new regulations by the end of transition period; requiring new Conformity Assessments under new rules for all devices currently circulating within the European Union. Manufacturers of devices falling under the scope of the new Medical Devices Regulation will have to comply with new legislation until 25 th May LifetecZONe, 21 September

28 Learning Outcomes Participate in the real-world of Medical Devices Experience real-world challenges Understand this Legislation Plan, Perform and Deliver LifetecZONe, 21 September

29 Contact for any Question Louis Habets Sr. Consultant Medical Devices tel +31 (0) mob +31 (0)

30 Thank you for your Attention LifetecZONe, 21 September

31 Chapter II: Making Available and Putting into Service of Devices Economic Operator 2 Authorised Representative Obligations of the Economic Operators any natural or legal person established within the Union who has recieved and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer s behalf in relation to specified tasks with regard to the latter s obligations under this Regulation. general obligations of the Authorised Representative (Article 11): o 7 points to consider under which: LifetecZONe, 21 September

32 Chapter II: Making Available and Putting into Service of Devices Economic Operator 2 Authorised Representative Obligations of the Economic Operators any natural or legal person established within the Union who has recieved and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer s behalf in relation to specified tasks with regard to the latter s obligations under this Regulation. general obligations of the Authorised Representative (Article 11): o 7 points to consider under which: LifetecZONe, 21 September

33 Chapter II: Making Available and Putting into Service of Devices Authorised Representative Obligations of the Economic Operators general obligations of the Authorised Representative (Article 11 / 12): o7 points to consider, under which: a) verify the EU Declaration of Conformity and the Technical Documentation have been drawn up that an appropriate Conformity Assessment Procedure has been carried out b) keep available a copy of the Technical Documentation, the EU Declaration of Conformity and, if applicable, a copy of the relevant certificate c) comply with the registration obligations and verify that the manufacturer has complied with the registration obligations LifetecZONe, 21 September

34 Chapter II: Making Available and Putting into Service of Devices Economic Operator 3 Importer Obligations of the Economic Operators any natural or legal person established within the Union that places a device from a third country on the Union market. General obligations of the Importer (Article 13) o10 points to consider 1.only devices that are in conformity with this Regulation 2. verify: (a) CE marked and that the EU Declaration of Conformity (b) manufacturer is identified and an Authorised Representative designated (c) Labeling and Instructions for Use (d) UDI assigned. LifetecZONe, 21 September

35 Chapter II: Making Available and Putting into Service of Devices 3. their location can be established as well as that any label does not obscure any information 4. the device is registered in the electronic system and add their details to the registration 5. storage or transport conditions do not jeopardise its compliance with the General Safety & Performance Requirements and comply with the conditions set by the manufacturer 6. keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and allow the manufacturer, Authorised Representative and distributors to investigate complaints 7. a device, not in conformity, shall immediately be reported to the manufacturer and its Authorised Representative, as well as, if very serious, to the Competent Authorities and the Notified Body co-operate to ensure that the necessary Corrective Action is taken. 8. complaints or reports of suspected incidents shall immediately be forwarded 9. keep a copy of the EU Declaration of Conformity and, if applicable, a copy the Certificates 10. cooperate with Competent Authorities on any action taken to eliminate or mitigate the risks posed by devices placed on the market. LifetecZONe, 21 September

36 Chapter II: Making Available and Putting into Service of Devices Obligations of the Economic Operators Economic Operator 4 Distributor any natural or legal person in the Supply Chain, other than the Manufacturer or the Importer, that makes a device available on the market, up until the point of putting into service. General Obligation of the Distributor (Article 14) 1. act with due care in relation to the requirements applicable 2. verify that all of the following requirements are met: (a) the device has been CE marked and that the EU Declaration of Conformity of the device has been drawn up; (b) the device is accompanied by the information to be supplied by the Manufacturer in accordance with Article 10(11); (c) for imported devices, the Importer has complied with the requirements set out in Article 13(3); (d) that, where applicable, a UDI has been assigned by the Manufacturer. LifetecZONe, 21 September

37 Chapter II: Making Available and Putting into Service of Devices 3. ensure that storage or transport conditions comply with the conditions set by the manufacturer; 4. if a device is not in conformity with this Regulation, inform the Manufacturer and the Authorised Representative and the Importer. Co-operate with the Manufacturer, the Authorised Representative, the Importer and the Competent Authorities to ensure that Corrective Action is taken. If a device presents a serious risk, inform the Competent Authorities immediately 5. received Complaints or Reports about Suspected Incidents shall immediately be forwarded to the Manufacturer, the Authorised Representative and the Importer. A register of complaints, non-conforming devices, recalls and withdrawals is maintained. 6. upon request by a Competent Authority, provide all information and documentation that is at disposal Cooperate with Competent Authorities on any action taken to eliminate the risks Upon request by a Competent Authority, provide free samples of the device LifetecZONe, 21 September

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