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Post marketing surveillance april 2011

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Post marketing surveillance april 2011

  1. 1. PMS, Risk Management Plans
  2. 2. Agenda• Legal Basis of PMS• Why it is Important?• Implementing PMS Throughout the Supply Chain• PMS as Key to Overall Compliance• British and Dutch Perspectives
  3. 3. Healthcare is Very Heavily Regulated• Healthcare may be the world’s most heavily regulated sector• In addition to general regulations (Bribery, Procurement, Product Liability, REACH and WEEE) there are rules re: – Design and testing of the device – Classification and certification of the device – Control of quality of the device and each component of the device – Promotion of the device (everything from to whom and contents) – Provision of information about the device (e.g. off-label promotion) – Interactions with Healthcare Professionals – Interactions with independent parties such as Notified Bodies and Authorised Representatives – Distribution of the device – Post Marketing Surveillance – Recalls, field safety corrective actions and field safety notices – Reimbursement• Increasing Harmonisation of International RequirementsInforma Brussels – May 2011 3
  4. 4. Obligations re PMS• Manufacturer must establish a Post Marketing Surveillance system for each product• PMS is a critical element of the Quality Management System – PMS plan must include mechanisms to monitor (and update) the QMS – Notified Body must continually audit Manufacturer’s compliance• Risk Management must also address PMS
  5. 5. Three Mandatory Elements of PMS1. Handling of complaints and reportable incidents2. Reviewing literature (and other sources of data) for similar/equivalent devices3. Vigilance reporting of reportable incidents
  6. 6. PMS Incorporated Beneficially• Well-Implemented PMS plans can provide significant benefits • Information should be fed into product design, marketing and M&A teams • Information should be used to assist with reimbursement negotiations, health technology assessments and label extensions • Assists with Product Liability claims and availability of defences• Vigilance obligations constantly increasing• EUDAMED???
  7. 7. PMS Extends to Subcontractors• The Manufacturer must control all activities including those subcontracted out• Level of control depends on the nature of the device and the nature of the component or service supplied by the subcontractor. – The control of a supplier of packaging will be different to that of supplier of power supply – The level of control may change over time – Requires an audit of each material subcontractor and its quality systems. This can be a direct audit of the subcontractor or an audit of its notified body.
  8. 8. Risk Management - Control of Outsourcing• While a Manufacturer may outsource – processes (sterilization, tooling, coating, testing, design, manufac turing); and – products (components, subassemblies or entire devices), it must maintain control.• Manufacturer must incorporate appropriate risk management activities for these processes and products by planning and by ensuring risk control measures are appropriately applied.• This includes evaluation of the supplier’s own systems and establishing systems to obtain feedback.• Recommended Reading: GHTF Guidance SG3/N17/2008Informa Brussels – May 2011 | 8
  9. 9. Types of Contracts• Subcontractors/Suppliers: – Design of device (or part thereof) – Manufacturing of device (or part thereof) – Development of software (or part thereof) – Production of components / raw materials – Supply of devices that form part of pack or system – Inspection / testing / sterilisation – Clinical evaluation (CRO) – Authorised Representative – Business unit of group of companies• Consultancy Agreements• Distribution Agreements• Agency AgreementsInforma Brussels – May 2011 9
  10. 10. Specific Contractual IssuesInforma Brussels – May 2011 | 10
  11. 11. Standards; “Compliance with Law”• Avoid “compliance with law” boilerplate – Tubing example: the tubing complied with “applicable law”, namely the law applicable to a supplier of rubber tubing, but not the MDD. – Software example: the revisions to the software was permitted for software that was not a medical device• Specify standards to follow – ISO 9001: for quality systems – ISO 13485: for medical devices – ISO 14971: risk management system for medical devices – ISO 62304: medical devices software development – That these are often addressed in an escalating process• For critical suppliers to decrease the risks of divergent practices, detail the obligations at an SOP levelInforma Brussels – May 2011 11
  12. 12. Standards and Change Control• Given the significance of the risk (Manufacturer may not stay within scope of CE marking), this is a critical issue• Mechanism for reporting design or QS changes• Mechanism for prior agreement to design or QS changes• Mechanism to compel support of previous version• Mechanism to force supplier to implement a change – Enhanced standards imposed in a recast of the MDD – Consider a right to take over (whether for bug fixes or to take to a supplier with an adequate QMS) – Consider limitation to “where required by a regulator or by law”Informa Brussels – May 2011 12
  13. 13. Traceability• For suppliers of critical components (or services) seek obligations regarding traceability of their batches• Expressly refer to vigilance and PMS obligations and impose contractual obligations on them to comply with these requirements• Notified Body should also have an interest in verifying this aspect of the quality system• Distributors must also have obligations as regards the products that they supplyInforma Brussels – May 2011 13
  14. 14. Intellectual Property• Ensure that the supplier/subcontractor provides a licence to copy, modify and sub-licence the relevant IP – Crucial for certain types of Field Safety Corrective Actions – This should extend to foreground and background IP – Query access to third party IP licensed to the supplier• Access to source code for software (escrow)• Consider consequences of insolvency of supplier• Consider consequences of termination• Consider IP Insurance (Offensive, Defensive and After the Event)Informa Brussels – May 2011 14
  15. 15. Record Keeping• Record-keeping obligations for a medical device manufacturer are an absolute requirement and are a crucial element of PMS• Automatic access rather than a contractual obligation to provide – little value if the supplier is insolvent or there is a breakdown in the relationship• Consider also a power of attorneyInforma Brussels – May 2011 15
  16. 16. Regulatory Actions• Some partners should be obliged to assist with regulatory matters – Investigations – Queries – Complaints – FSCAs – Recalls• Dual (prompt) notification and, where appropriate, Manufacturer should have the opportunity to make representations• Assistance (at counter-party’s cost) with disputes, responses etc• Include obligations re PMS (particularly vigilance and market feedback) in certain cases• Agree process for the co-ordination of : – responses to threats, claims and litigation by third parties; – enforcement and inspection matters; and – EUDAMED filingsInforma Brussels – May 2011 16
  17. 17. Consequences of Termination• Enable new supplier to take over the work and understand procedures• Intellectual Property (foreground and background): – transfer to Manufacturer; or – perpetual, irrevocable, royalty-free, worldwide, sub-licensable and probably non-exclusive (consider exclusive or sole) licence to use and modify IP• Transfer of information and know-how• Release of source code or documents from escrow• Ensure all relevant regulatory data is handed over in a readable form – Old subcontractor may not have an obligation to retain the data• Right to source raw materials• Consider a positive obligation to assist (e.g. show-how) – any significant changes may need to be looked at by the Notified Body! – probably a sunset clause on such a provisionInforma Brussels – May 2011 17
  18. 18. Change of Control/Assignment• If a subcontractor makes a critical component – provide for options to avoid Sophie’s Choice • terminate agreement if the subcontractor is acquired, e.g. by competitor, or • make agreement difficult to terminate, e.g. by means of poison pill, or • level the playing field with an MFN clause – subcontractor should not assign its contractual obligations or the entire agreement – subcontractor should not to subcontract outside of scope of QS auditInforma Brussels – May 2011 18
  19. 19. Miscellaneous• Inspection and Acceptance – Avoid deemed acceptance provisions in a supplier contract where inspection is either difficult or impossible (e.g. sealed until used)• Exclusivity – Can become a double-edged sword commercially • supplier may not have access to industry or QMS improvements (conversely, it may not have the ability to meet multiple QMS requirements) • supplier may become overly dependent on Manufacturer • Manufacturer may become overly dependent on the supplier if mutual – Consider a limited field or priority of supply or MFN – Beware competition Issues (present and future)Informa Brussels – May 2011 19
  20. 20. Miscellaneous (2)• Claims Management and Product Liability – Subcontractor has an interest to argue that the defect is attributable to • the overall design of the device; • the instructions given by the Manufacturer• Power of Attorney to allow Manufacturer to execute documents – If counter-party objects – limit to situations where: • the counter-party refuses to do act; • the counter-party is incapable of taking the action; and/or • Manufacturer [acting reasonably] determines that the action is critical.Informa Brussels – May 2011 20
  21. 21. Miscellaneous (3)• Force Majeure – Ensure that Force Majeure clause is appropriate to the circumstances – Positive obligations to assist to overcome or develop a workaround• Severability of provisions – Challenges to procurement decisions and opportunity to rewrite contracts – Consider benefits or otherwise of interlinking provisions• Choice of Law and Forum – Specifically consider arbitration in countries with maturing legal systems: • China (often in Hong Kong); and • India (often in Singapore)Informa Brussels – May 2011 21
  22. 22. Case StudiesInforma Brussels – May 2011 | 22
  23. 23. Tubing Component for Pump• The tubing complied with the technical specification, but did not work as anticipated in the clinical environment• The tubing was not defective (as per the supply agreement), but resulted in a Field Safety Corrective Action of the device• The supplier was not contractually obliged to: – Provide feedback regarding the actual performance of the tubing – Assist with the FSCA – Meet the additional specifications for the medical device – Undergo an audit by the Notified Body• The relationship deteriorated and the supplier would only assist with the FSCA on payment of a significant sumInforma Brussels – May 2011 23
  24. 24. Supplier of Software Component• The diagnostic device (scanner) incorporated third party software• The GUI and the database management software was not supplied exclusively to the device company or to the medical device sector• The software company updated the GUI and the database management and deployed automatically via the internet• No clinical investigations were undertaken in respect of the upgrade/update• The scanner no longer complied with the CE Mark• Potential Consequences – Product Recall – Suspension of Sales while new CE Mark obtained – Loss of Insurance cover• The device company did not have the right to: – copy or modify the software; – reinstate previous versions of the software; – be notified of the upgrade; or – prevent the upgrade being deployedInforma Brussels – May 2011 24
  25. 25. Insolvent Supplier• The device company and the supplier jointly fund the development of the tool to manufacture the component• The component is crucial• The supplier will own the tools and associated IP but: – will only use the tool for the device company; or – grants the device company a perpetual, royalty-free licence of IP• The supplier becomes insolvent• The liquidator disclaims the licence to the device company and sells the IP/tools to a third party – The same issues arise with software source codeInforma Brussels – May 2011 | 25
  26. 26. Thank You• The information in this presentation is provided for information purposes only. The information is not exhaustive. While every endeavour is made to ensure that the information is correct at the time of publication, the legal position may change as a result of matters including new legislative developments, new case law, local implementation variations or other developments. The information does not take into account the specifics of any persons position and may be wholly inappropriate for your particular circumstances. The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.• Unless otherwise stated, the information is limited to the position in the UK and the Netherlands.•Alex Denoon: Erik Vollebregt +44 20 3441 0908 (office) +31 20 30 17 436 (office) +44 7540 123 519 (mobile) +31 6 47 180 683 (mobile) alex@lawforddaviesdenoon.comvollebregte@eu.gtlaw.comInforma Brussels – May 2011 | 26

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