Changes to Medical Device Regulations
IMSTA Breakfast Briefing, 24 October 2013
Niall MacAleenan
Medical Device Lead, IMB.
How these will affect distributors?
• 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
Content
• 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
Revision of the device legislation
• Continued discussions at European level – seeking 1st reading agreement by the end of 2013
• Milestone – end of term of European Parliament and Commission Q1/Q2 2014
• 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 10-15 years
Timing of new legislation
• 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
Crises regarding implants
• Action plan for authorities, MS and COM over 2012-2013
• 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 2014 - 2015
Joint plan for immediate actions
• 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
Proposals for Regulations
1. Uniform control of Notified Bodies
2. Enhanced legal clarity and coordination in the field of post- market 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
Key objectives of revision
‘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?
Definitions of economic operators
• 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
Proposed obligations on distributors
‘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
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
Proposed obligations on importers
24/10/2013 12
• 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
Proposed obligations on importers
• 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
Person responsible for regulatory compliance
• 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
Applicability of manufacturer obligations
• 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
Single use device - reprocessing
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
System & procedure packs
• 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
Part & components
• 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
Unique Device Identification (UDI)
• Distributor SI in draft at DOH
• Associated best practice guidances
• Consultation period
• National legislation is likely before Regulation is in place