Changes to Medical Device Regulations

Transcription

1 Changes to Medical Device Regulations How these will affect distributors? IMSTA Breakfast Briefing, 24 October 2013 Niall MacAleenan Medical Device Lead, IMB. Slide 1

2 Content Revision of the medical device legislation Recent crises and joint action plan Defining roles & responsibilities of different economic operators Potential impacts on distributors Person responsible for regulatory compliance Application of manufacturer obligations Reprocessing of single use devices Traceability & Unique Device Identification National distributor legislation 2

3 Revision of the device legislation 3 main Directives & 7 implementing consolidated to 2 proposed Regulations 26 September 2012 formally adopted by the European Commission Ordinary legislative procedure parallel discussions at European Council & European Parliament co-decision European Council Working Party Irish Presidency of the European Council Jan June 2013 European Parliament ENVI committee, EP plenary 3

4 Timing of new legislation Continued discussions at European level seeking 1 st reading agreement by the end of 2013 Milestone end of term of European Parliament and Commission Q1/Q Staggered implementation 6 months notified body elements & MDCG 18 months registration & certificates 3 years full MD Regulation 5 years full IVD Regulation Determine framework for next years 4

5 Crises regarding implants Poly Implant Prosthese (PIP) - France Metal on metal hip implants, UK registry Resulted in - Significant distress and hardship for patients - Significant attention on medical devices regulatory system - European Commission stress test of existing proposals - European Commissioner s Joint Plan for immediate actions - Substantive revisions of draft legislation, significant focus from European Parliament 5

6 Joint plan for immediate actions Action plan for authorities, MS and COM over Function & oversight of notified bodies joint assessment, designation reviews, new legislation, unannounced inspections, increased safety communication Enhanced market surveillance of medical devices more in market controls, sampling, UDI Coordination & cooperation Communication & transparency - increased reporting from HCPs Strengthen existing system in advance of the new legislation, next steps

7 Proposals for Regulations COM(2012) 541 and COM(2012) 542 outlined proposals for IVD Regulation and MD Regulation Hugely complex legal texts 97 articles (currently 23) and 15 Annexes (currently 12) Main text relevant to distributors and economic operators in Chapter 2 and 3, however chapter 1 and 7 also have particular relevance Regulation does not require transposition into national law more consistency, less scope for national requirements, text needs to be more precise 7

8 Key objectives of revision 1. Uniform control of Notified Bodies 2. Enhanced legal clarity and coordination in the field of postmarket safety 3. Cross-sectoral solution of "borderline" cases 4. Enhanced transparency regarding medical devices on the EU market, including their traceability 5. Enhanced involvement of external scientific and clinical expertise 6. Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales 7. Governance - efficient and effective management of the regulatory system 8

9 Definitions of economic operators to set out clearly the general obligations of the different economic operators, including importers and distributors.. Articles 8 12 set out obligations on different economic operators Increase responsibility, traceability and transparency throughout the supply chain, increased accountability Increased responsibility placed on distributors and importers in particular, mandatory authorised representative but in a service type role Some overlap in responsibilities, requires some further development and clarification Is the current distribution of responsibilities correct? 9

10 Proposed obligations on distributors Distributors shall act with due care in relation to the requirements applicable Verify product is CE marked, IFU/information, UDI, importer details Suspect non-conforming device inform manufacturer/ar take necessary corrective action, withdraw or recall Where device presents a risk inform Cas Ensure storage and transport does not jeopardise conformity to safety and performance requirements (Annex I) Relay complaints or reports from HCPs and patients to the manufacturer/ar Responsive & cooperative to CA requests provide documents 10

11 Proposed obligations on importers importer means any natural or legal person established within the Union who places a device from a third country on the Union market; Ensure appropriate conformity assessment has been carried out Ensure an authorised representative has been designated Ensure that the DOC and technical documentation has been drawn up by the manufacturer Ensure that the device is CE marked Ensure that the device label meets the requirements and is accompanied by IFU, relevant information 11

12 Proposed obligations on importers Ensure a UDI has been assigned Act against suspected non-conformity not place device on market, take corrective action, withdraw or recall Inform manufacturer/ar and CA if risk detected Place importers name & contact on device label Ensure device is appropriately registered on European database Ensure transport and storage do not compromise conformance with the Safety and Performance Requirements 12

13 Proposed obligations on importers Conduct testing of samples Investigate complaints and maintain a register of complaints and keep manufacturer, authorised representative and distributors informed of this monitoring Relay complaints from HCPs and patients to manufacturer/ar Retain a copy of the DOC and ensure technical documentation and certificates are available on request Responsive & cooperative to CA requests provide documents 13

14 Person responsible for regulatory compliance Specific qualifications or experience in regulatory affairs Ensure conformity of devices, up to date technical documentation, vigilance reporting and CI obligations fulfilled Applicable to manufacturers and authorised representatives Different sets of requirements for custom made devices, Ars and micro and small-enterprises 14

15 Applicability of manufacturer obligations Own-brand labelling Change intended purpose of device Modifies device such that compliance affected Not considered manufacturer if supplying IFU (incl. translation) & outer packaging Must notify manufacturer and CA Have QMS to ensure translation, safe repackaging, complaints/reports Need to have QMS certified by notified body 15

16 Single use device - reprocessing Reprocesser becomes manufacturer Critical use devices only if scientific evidence of safety COM will produce and update lists of critical use devices which can be reprocessed Reprocessor identified on label MS may prohibit reprocessing/use of reprocessed devices 16

17 System & procedure packs Draw up statement - have verified mutual compatibility - packaged system pack and supplied IFUs accompanying original device - assembly subject to internal monitoring, verification & validation - sterile system pack in accordance with manufacturer instructions of devices - If not CE marked or not compatible must be CE marked 17

18 Part & components Replace identical/similar integral part that is defective or worn to re-establish function without change to performance and safety Evidence that no impact on performance and safety Article which significant changes performance and safety characteristics shall be considered a device 18

19 Unique Device Identification (UDI) UDI device identifier (model/manufacturer) & production identifier (unit of production) UDI entity to assign UDIs COM/MS to set up system to track UDIs Economic operators to electronically store UDI (device/production info), where they supplied and who supplied them Risk based approach to application of UDI 19

20 National legislation Distributor SI in draft at DOH Associated best practice guidances Consultation period National legislation is likely before Regulation is in place 20