Informa Eudamed update 29 january 2014

EUDAMED KEY CHANGES AND IMPACT ON INDUSTRY

Informa Medical Devices Directives & Revision29 January 2014

Erik Vollebregtwww.axonlawyers.com

Objectives

• What is planned in regards to enhancements to the Eudamed database?• How will the database be operated?• Assessing how the database will change the way of working from an

industry perspective once finalised• Examining the key challenges that will come with the database

The ghost of Eudamed past and presentConclusions:

• Eudamed is useful

BUT

• Very slow• Not user friendly• Member states often lack

IT resources to effectively use Eudamed and many will not have them ready soon

• Eudamed does not deliver in market surveillance

• Information in Eudamed is limited, incomplete, insufficient

The ghost of Eudamed past and present“Structural Problems with Eudamed and proposed changes in the Revision of the Medical Device Legislation”

• No complete overview of actors and devices on the EU market• No sufficiently coherent rules as to the detail of registration data• No public transparency• CAs do not have the resources to enter data• Data ownership rules make database difficult to work with

BUT

• Direct data entry by huge number of parties• Public transparency• UDI accommodation

WILL ALL BE NO PROBLEM

The Eudamed “cathedral”

Source: Jacques Thielen, Medtronic

The Eudamed “cathedral”

• Will Eudamed realistically be ready to support

• all these functions• in time?

“Who knows where the road may lead us, only the fool would sayWho knows if we'll meet along the wayFollow the brightest star as faras the brave may dareWhat will we find when we getthere”[Alan Parsons Project – La Sagrada Familia]

OR

MDR revision

• Eudamed will contain integrated electronic systems on

• European UDI• Registration of devices and economic operators• Certificates issued by notified bodies• Clinical investigations, on vigilance and on market surveillance• Registration of subsidiaries and subcontractors of notified bodies• Special notified bodies

• A large part of the information in Eudamed will become publicly available in accordance with the provisions regarding each part of the electronic system

• Will “do away with diverging national registration requirements which have emerged over recent years and which have significantly increased compliance costs for economic operators. It will therefore also contribute to reducing the administrative burden on manufacturers.”

MDR revision

• Access

• Member states and Commission: unlimited access• Rest (NoBos, economic operators, sponsors, HCPs and patients) on

need to know basis

• Development & management

• Commission lays down modalities necessary for the development and management of Eudamed in implementing acts

Supply chain / UDI

• UDI system to be set up by Commission, in cooperation with the Member States, to collate and process information to describe and identify the device and to identify the manufacturer and, where applicable, the authorised representative and the importer; details in Annex V.

• Importers shall ensure that the device is registered in the electronic system for UDI – every chain checks compliance of previous one

• Commission takes delegated acts to fill in details

Notified bodies

• Subsidiaries and subcontractors publicly accessible in Eudamed:

• Information on notification of NoBo plus assessment reports joint assessment team and MDCG recommendation: publicly available

• Changes to notification of NoBo in Eudamed: not certain if public (art. 36 (5) last par)

Special notified bodies

Notified bodies

• Certificates and related information in Eudamed

• System will collate and process information on certificates issued by notified bodies

• Notified body enters information regarding certificates • Issued (including amendments and supplements)• suspended, reinstated, withdrawn or refused certificates and • restrictions imposed on certificates.

• Accessible to the public

Clinical investigations

• Eudamed assigns clinical investigation numbers for application to system• Sponsor registers article 52 prescribed details into system regarding the

clinical investigation prior to start• Any changes to investigation must be entered into Eudamed within a

week

• “Upon completion of the clinical investigation, the sponsor shall enter in the electronic system a summary of its results drawn up in a way that is easy for a lay person to understand.”

• All clinical investigation information that must be entered is completely accessible to the public, unless confidentiality exception applies (implementation of exception not described)


• System will collate and process:

(a) the registration of clinical investigations and associated details to be provided;(b) the exchange of information between the Member States and between them and the Commission regarding refusal, suspension, termination and withdrawals of applications;(c) the information related to clinical investigations conducted in more than one Member State in case of a single application in multiple member states;(d) reports on serious adverse events and device deficiencies in case of a single application in multiple member states(da) the clinical investigation report and summary submitted by the sponsor in case of early termination

• Plus: Annex XIII part B sub 1: PMCF clinical data


• Commission must

• build Eudamed as to be compatible with EudraCT• Implement HCP and public access to authorised parts

• HCPs: full access• Public: reports on serious adverse events and device

deficiencies and the clinical investigation report and summary submitted by the sponsor

• Parliament:

• “Upon a reasoned request, all information on a specific medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified in accordance with Article 52(3).”

• Commission takes implementing acts re the functioning of the electronic system

Vigilance• Parliament:

• Manufacturers report any incident in Eudamed • CAs file all suspected serious incidents reported by patients

and HCP in Eudamed

Electronic system on vigilance

• What’s in it?

(a) reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 61(1);(b) periodic summary reports by manufacturers;(c) HCP and patient reports by competent authorities on serious incidents;(d) reports by manufacturers on trends;(da) the periodic safety update reports drawn up by manufacturers (new proposed article 63a);(e) field safety notices by manufacturers;(f) information to be exchanged between the competent authorities of the Member States and between them and the Commission.


• Access

Electronic system on vigilance• Distribution of information


Market surveillance Transm

ission of inform

ation to

Market surveillance

• Measures against economic operators with non-compliant devices presenting a risk to health and safety go in Eudamed

• In case of cross-border non-compliance member states shall immediately inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operators to take, by means of Eudamed

• National provisional measures to restrict device being made available against economic operator that does not take adequate and timely corrective action

• Information about the non-compliance of the device subject to the above

• Preventative health measures against a device or a specific category or group of devices go in Eudamed

Conclusion on the Eudamed cathedral

Will the Commission be on the …

In the end …

Will it be …

Will it be in time or way …

Will it get us …

Will we have a more transparent overview …

BUT

• Will we even have a final regulation this year? • It looks less and less likely that we will

www.axonlawyers.com

THANKS FOR YOUR ATTENTION

Erik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E [email protected] @meddevlegalB http://medicaldeviceslegal.com

READ MY BLOG:http://medicaldeviceslegal.com

Legal stuff

• 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 person's 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.

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Informa Eudamed update 29 january 2014