Post on 12-May-2018
Preparing for new
regulations
23rd October 2014
Nicola Hickie,
Medical Devices Assessor
Responsibilities of economic operators
Crowne Plaza Hotel, Northwood, Santry.
EU Commission
proposal for a
regulation of the
European Parliament
and of the Council
on medical devices
(542/2012)/
... on in vitro
diagnostic medical
devices (541/2012)
23/10/2014 2
ST 5458/14:
http://register.consilium.europa.eu/content/out?lang=EN&
typ=ENTRY&i=SMPL&DOC_ID=ST-5458-2014-INIT
Challenge
• Obligations of Economic Operators
(Chapter II)
• Information required to build
transparency, identification and
traceability (Chapter III)
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• Transparency
• Build Confidence
Focus
Clarification of obligations
• Manufacturer responsibility – clear set of requirements
• Demonstrate conformity – technical documentation
and EU Declaration of Conformity (Annexes II and III)
• General safety and performance requirements (Annex I)
- CTS
• Requirements on clinical evaluation/evidence and post-
market [clinical] follow-up (Annex XIII - medical
devices/ Annex XII IVDs)
• At least one person responsible for regulatory
compliance (RP)
• Provision of essential information to patients
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Manufacturer – article 8
• The 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 his name or trademark.
• Regulatory requirements proportional to risk
• Document and implement a QMS that minimises non-conformance (Article 8 para 6).
• Technical Documentation and DoC required to demonstrate compliance with legal requirements – keep for 10 years1.
• DoC to accompany device
1CWP discussions have suggested a change from 5 – 10 years. And 15 years for implantable devices.
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• Comply with the obligations related to the UDI system (article 24)
• Comply with EO and device registration requirements (article 25)
• Implement a post market surveillance plan
• Include a plan for post market clinical follow up – Annex XIII part B
• Report on post market surveillance2
• Labelling and IFU (Annex I)
• Non-conforming device – inform stakeholders
• Cooperate with competent authority requests 2Distinction between post market surveillance (MFR) and market
surveillance (CA)
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Authorised Representative (AR) – article 9
• Manufacturer outside of the EU – designate an AR within the EU
• Accept role in writing
• Written mandate agreed
• AR provides copy of mandate to importer & CA on request
• AR terminates mandate – inform the competent authority
• Have a person responsible for regulatory compliance (RP) at their disposal
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Authorised Representative - mandate
• Copy of technical documentation, DoC, NB certificate
• Comply with registration obligations (article 25)
• Provide the CA with information & documentation demonstrating conformity
• Cooperate with the CA on any corrective actions to eliminate risks
• Immediately inform manufacturer of complaints
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Importers – article 11
• Any natural or legal person established within the Union who
places a device from a third country on the Union market;
• Verify that an AR has been designated and notified of the
devices the importer is placing on the market
• EU DoC / CE marked/ Labelling and IFU
• UDI assigned by the manufacturer
• Inform stakeholders of non-conformities/risks – full
engagement of manufacturer
• Verify that device is registered on electronic system (article
25) – add importer details
• Name and address of registered business
• Register of complaints
• Cooperate with authorities and inform relevant stakeholders 23/10/2014 10
Distributors – article 12
• Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market;
• Only make available devices in conformity with regulation
• Verify CE/ DoC/ IFU provided
• UDI verification
• Importer/ manufacturer registration requirements met
• Inform manufacturer and AR where device is non-conforming or presents a risk
• Storage & transport conditions are met
• Cooperate with Competent Authority and manufacturer
• Register complaints and forward to manufacturer
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Person responsible for Regulatory Compliance –
article 13
• Manufacturers shall have permanently at their disposal a ‘responsible person’
• Expert knowledge in Medical Devices field
• Conformity is appropriately checked in accordance with the quality system
• TD and DoC drawn up
• Post market surveillance obligations
• Information on risks associated with devices is collected and evaluated and measures coordinated
• Reporting obligations are fulfilled
• AR shall have at least one RP who possesses expert knowledge on regulatory requirements for devices in the Union
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Parallel trade – article 14
• Clear conditions set for EOs involved in re-labelling or packaging of devices
• Obligations of manufacturer carry over to EO’s, when:
– make available on the market a device under his name, registered trade name or registered trade mark;
– change the intended purpose of a device already on the market;
– modify a device already on the market in such a way that compliance with the applicable requirements may be affected
Parallel importer requirements
• Indicate the activity carried out, his name and address on the device
• Ensure a QMS in place ensuring translation of information is accurate and up-to-date
• Activities preserve original condition of device
• Packaging is not defective or of poor quality
• QMS to include procedures ensuring the distributor/ importer is informed of Corrective actions in response to safety issues
• Prior to making devices available – inform the manufacturer and CA – sample of relabelled device
• Submit a NB certificate attesting that the QMS complies with requirements
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Chapter III
Identification & traceability
• EO’s must have oversight of the supply chain
• manufacturers to fit their device with a UDI
Registration of devices & EO’s
• manufacturers, authorised representatives and importers - register on a central European database
SSCP data
• Obligation to make the summary of safety and performance data publicly available for high risk devices
Further development of European databank
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Unique Device Identification
Chapter III Article 24 MDR/ Article 23 IVDR
• Requirements of the UDI System:
• Production of UDI (DI + PI)
• Placement of UDI on label of device
• Establishment of electronic system on UDI
• Storage of the UDI through electronic means
• Comm to designate a number of entities that operate a system for assignment
• Mfr shall assign a UDI before placing a device on the market
• EO’s shall store and keep by electronic means the DI and PI of their devices
• The Commission, in cooperation with the Member States, shall set up and manage an electronic system on UDI to collate and process the information.
• Accessible to the public.
• UDI shall be used for reporting serious incidents and field safety corrective actions
Slide 17
UDI No.
DI:
PI:
UDI No.
DI:
PI:
UDI No.
DI:
PI:
To:
To: To:
From: From:
European UDI Database:
UDI No; DI data only
Mfr Distr Hosp
Registration of devices & EOs (Art 23 IVDR/ Art
25 MDR)
• ALL devices registered on central EU database
• Visibility of the supply chain
• Annex V, Part A
• Manufacturer/ Importer/ Authorised Rep
• UDI device identifier
• NB certificate details
• Accessible to the public
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Summary of safety and [clinical] performance
(Art 26 MDR/ Art 24 IVDR)
• Class III implantable and devices emitting ionising radiation – drawn up by MFR
• Class C and D IVDs
• Clear to intended user and patient
• Available to public via Eudamed
• Summary data provided with the device
– Intended purpose
– Description of accessories
– Limitations of device
– Clinical performance
– Clinical evidence
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EUDAMED (Data stored in the European MD databank)
Electronic
System
on
Certificates
Electronic
System
on
Vigilance
Electronic
System
on
Clinical
Investigations
&
Clinical
Performance
Studies
Electronic
System
on
market
surveillance
Information on
measures taken
by MS in case of:
Non-compliant devices
presenting a risk to
health and safety;
Compliant products
presenting a risk
to health and safety;
Formal non-compliance
of devices;
Preventive health
protection measures.
Electronic
System
on
Unique
Device
Identification
(UDI)
Information on:
DI data elements
Electronic
System
on
Registration
Information
on
devices
and
Economic
operators.
EUDAMED (Data stored in the future European MD databank art 27 (MDR)/ Art 25 (IVDR))
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Challenges & Opportunities
Opportunities Challenges
Increased traceability Practical aspects to be defined –
national registers/ DoC/ AR
mandate
Increased transparency EO’s roles – appropriately defined?
Increased access to information Importer/ Distributor versus AR/
RP obligations
Clarification on roles and
responsibilities
Registers – Eudamed/ Complaints
and how they interface
Decrease in diverging national
requirements
Decrease in administrative costs
(long term)
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Final thoughts...
• Good progress w.r.t. clarifying weaknesses
of current Directives
• Positive impact on patient safety
• Clarification required on practicalities
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