Person Responsible. Requirements. for Regulatory. Door Leo Hovestadt

Transcription

1 Person Responsible for Regulatory Requirements Door Leo Hovestadt

2 Agenda Oversight Competant Authority Availability MDR BREXIT Notified Body Availability License to sell due dates MDR 2020 UK 2019 Quality System Certification(s) Technical File certification(s) MDD (IIa,b/III) 2020 & 2024/5 ROW 2019 Economic Operators Quality System / Organisation Product / Labelling / Doc. MDD (I+S/M) 2020 (-> IIa 2024?) Third Party 2020 & 2024/5 Manufact. Location Importer PRRC Art 15 Vigilance, PMS, etc Clinical Evaluation & Investigation No grandfathering MDD portfolio Authorized Rep Distributor Classification UDI Regulatory Changes MDSAP MDR & local law Del. & Impl. Acts Harm. Stds & CS GDPR REACH RED EURATOM

3 Artical 15.1, 2 & 6 PRRC Availability and Expertise 1.Manufacturers shall have available within their organization at least one PRRC (implies backup) 2.SME shall have permanently and continuously at their disposal (not req. in organization) at least one PRRC 6.Authorised Representatives shall have permanently and continuously at their disposal at least one PRRC (implies backup) who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

4 15.4 PRRC joint responsibilities 4.If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing. inside EEA Mfr multiple PRRC

5 15.2 PRRC Availability in SME 2.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. (1)Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, , p. 36). inside EEA SME < 50 empl < 10M sales

6 15.6 PRRC at Authorized representative 6.Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. outside EEA Mfr inside EEA AR Imp Dist 11.4.The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).

7 Now What does a Brexit mean and the MDR? Hard Brexit Hard Brexit & MDR EEA Free Market EEA Free Market EEA Free Market EFTA EFTA EFTA Dist Imp Dist Imp AR AR AR AR AR MRA WTO MRA WTO MRA WTO WTO

8 15.1, 2 & 6 PRRC Availability 1.Manufacturers shall have available within their organization at least one PRRC Article 2(30) manufacturer means 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; inside EEA Mfr inside EEA Mfr multiple PRRC inside EEA SME < 50 empl < 10M sales outside EEA Mfr inside EEA AR Imp Dist

9 Annex VI (part A section 1.4) requires PRRC registration Annex VI part A Information to be Submitted upon the Registration of Devices and Economic Operators in Accordance with Art 29(4) and name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.

10 3.The PRRC shall at least be responsible for ensuring that: 15.3 PRRC responsibilities 3. De PRRC, is er ten minste verantwoordelijk voor dat wordt toegezien op het volgende: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept upto-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. a) voordat een hulpmiddel wordt vrijgegeven, wordt de conformiteit van de hulpmiddelen naar behoren gecontroleerd overeenkomstig het kwaliteitsmanagementsysteem in het kader waarvan de hulpmiddelen worden geproduceerd; b) de technische documentatie en de EU-conformiteitsverklaring worden opgesteld en geactualiseerd; c) de verplichtingen in verband met post-market surveillance overeenkomstig artikel 10, lid 10, worden nagekomen; d) de verplichtingen in verband met het rapporteren van de artikelen 87 tot en met 91 worden nagekomen; e) in het geval van hulpmiddelen voor onderzoek wordt de in punt 4.1 van hoofdstuk II van bijlage XV bedoelde verklaring verstrekt.

11 15.3 PRRC responsibilities <-> ISO Mgt Rep 3.The PRRC shall at least be responsible for ensuring that: Management representative. Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept upto-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; a) ensuring that processes needed for the quality management system are documented; b) reporting to top management on the effectiveness of the quality management system and any need for improvement; c) ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

12 15.3 PRRC responsibilities <-> ISO Mgt Rep 3.The PRRC shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept upto-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. The PRRC will usually: participate in Quality Management Review meetings follow up on quality metrics initiate non-conformities Initiate corrective and preventive actions or improvements interact with Competent Authorities ensure that non-compliant products are removed or do not reach the market The PRRC usually needs: full access (e.g. technical documentation and certificates) adequate authority to initiate product hold, CAPA, QMS change request, etc an escalation process to allow a direct communication line to senior management sufficient documentation to demonstrate his/her track record is complete

13 3.The PRRC shall at least be responsible for ensuring that: 15.3 PRRC responsibilities (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. Annex II 3. Design and Manufacturing information & 4. General Safety and Performance Requirements (= Annex I) Annex II / III: Technical Documentation (on PMS) Annex IV: EU Declaration of Conformity Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Art 83. Section 2 Vigilance Art 87 Reporting of serious incidents and field safety corrective actions Art 88 Trend reporting; Art 89 Analysis of serious incidents and field safety corrective actions; Art 90 Analysis of vigilance data; Art 91 Implementing acts Annex XV Chapter A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the GSPR apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.

14 15.3 PRRC responsibilities what to do? QMS Audit Check Do Responsibility cannot be delegated PRRC 15.3c 15.3.The PRRC shall at least be responsible for ensuring that: (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); Mfr Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Art 83. The PMS system is according Art 83 Sign off QMS 10.9i (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Art 83; The PMS system is described in the QMS Sign off Techfile Annex III: 1.1 The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Art 83. The PMS obligations are described in a plan Author??? Art 84 Plan, Art 85 Report, Art 86 PSUR Etc. Evidence

15 15.6 PRRC at Authorized representative 11.4.The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). Art 10.x: 1. Ensure devices have been designed and manufactured in accordance with the EU MDR requirements. 2. Establish, document, implement and maintain a system for risk management. 3. Conduct a clinical evaluation, including post-market clinical follow-up ('PMCF'). 4. Draw up and keep up to date the technical documentation. 6. Draw up an EU declaration of conformity. 7. Comply with the obligations related to the UDI system and with the manufacturer's registration obligations. 8. Keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, for a period of at least 10 / 15 years years. So an AR PRRC can do this 9. Ensure that procedures are in place to keep series production in conformity with the EU MDR requirements. Establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance. 10. Implement and keep up to date the post-market surveillance system. 11. Ensure that the device is accompanied by the information to be supplied in accordance with Section 19 of Annex I in an official Union language(s) determined by the Member State where the device is made available to the user or patient. 12. In case the device would not be in conformity, immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. Inform the distributors and, where applicable the EU AR and importers, accordingly

16 15.6 PRRC at Authorized representative Responsibilities of the PRRC of the AR can include: Keep available a copy of the technical documentation, the EU declaration of conformity and, of the relevant certificates Comply with the registration obligations Cooperate with the competent authorities, providing them with the requested information (device conformity, vigilance, preventive & corrective actions) Forward to the manufacturer any request by a competent authority Immediately inform the manufacturer about complaints and reports about suspected incidents Ensure the AR terminates his mandate if the manufacturer acts contrary to its obligations

17 15.5 PRRC shall suffer no disadvantages 5.The PRRC 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. Dus: Bij onenigheid over goed uitvoeren van de functie, ligt de bewijslast bij de werk- (of opdracht-)gever. -> Set up a process to avoid the PRRC suffering disadvantage from undertaking his/her duties

18 Enforcement in local NL law Regels over de veiligheid en kwaliteit van medische hulpmiddelen (Wet medische hulpmiddelen) Artikel 12 Last onder dwangsom Onze Minister is bevoegd tot oplegging van een last onder dwangsom ter handhaving van: a. 15, eerste tot en met vierde lid, 15, zesde lid Dus: Liabilities voor strafrecht liggen bij de werk- (of opdracht-)gever.

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