How to implement the New Legal Obligations of Economic Operators

in EU MDR

Erik VollebregtAxon Lawyers

Essential Tools for MDR / IVDR supply chain

• MDR (Regulation 745/2017) and IVDR (Regulation 2017/746)

• Blue Guide 2016

• Commission interpretative document on placing on the market

• Decision 768/2008

EU supply chain regulation has evolved (a lot) and that was totally expected

Where are you with your company’s transition to MDR / IVDR?

Supply chain controls: chapter II

Manufacturer Importer Distributor

EndUser

Post market surveillance and vigilance

Regulatory compliance of device

Verify compliance Verify compliance

Supplier

Unannounced NB inspections

Overlap Overlap

Division of responsibilities

Definitions regarding economic operators (“MAID”)

New stuff in chapter II compared to Decision 768/2008 re EOs

• Includes some provisions that create ‘new’ EOs, new liability and claims regulation

• Distance sale provision (art. 6)• Claims (advertising) (art. 7)• Prescriptive and policing independent AR, which is jointly and severally product liable (art.

11)• Cases in which obligations of manufacturers apply to importers, distributors or other

persons (art. 14)

• Repacking / relabelling regime – medicinal products modelled but stricter than CJEU Servoprax judgment

• PRRC (art. 15)• Reprocessing (art. 17)• DOC to be updated continuously and translated in languages required by the Member

State(s) in which the device is made available (art. 19)• Cases where parts / components suppliers must validate part / component or be

manufacturer of device (art. 23)

New stuff in Blue Guide that is often overlooked

• The role of fulfilment houses (FHs) as service provider to EOs (section 3.4)

• If their activities “go beyond those of parcel service providers that provide clearance services, sorting, transport and delivery of parcels […] they should be considered as distributors and should fulfil the corresponding legal responsibilities.”

• Many medical devices companies find that their FHs are not ‘neutral’ service providers but MDR regulated distributors ex art. 14 MDR as a result of the services they provide

Manufacturer

• Article 10 obligations as elaborated in MDR / IVDR

• New:– UDI (art. 10 (7))– All MFRs must be able to provide complete technical

documentation (OBL impact) (art. 10 (8))– Risk management plan, PMCF plan, clinical evaluation,

QMS, vigilance described prescriptively in detail in MDR / IVDR

– Provisions on product liability, insurance and cooperation with authorities / claimants in product liability cases

Authorised Representative

• AR become outsourced compliance officer at risk for product liability

• Article 11 provides for mandatory included and excluded items for AR mandate– AR must terminate mandate if the MFR acts contrary

to its obligations under MDR/IVDR– AR must inform CA if AR terminates mandate for MFR

non-compliance

• Article 12 provides for AR mandate handover regime, preferably by means of 3 party agreement

Importer• Next important operator concerning compliance after manufacturer (“Blue Guide”)

• Art. 13: In order to place a device on the market, importers shall verify that:

a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;

c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;

d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27

• Importers must label device with their details

• Importers have their own vigilance report and compliance monitoring requirements

• Definition of importer(s) in supply chain in practice problematic for many companies

– When does the ‘first placing on the market’ occur, and by whom?

– Definition of importer in other legislation (e.g. tax) irrelevant for MDR / IVDR definition

– MDR / IVDR goods flow based, while tax law ownership/financial risk based

Distributor

• Largely the same obligations as IMP, but no obligation to label• Before making a device available on the market, distributors shall verify

that all of the following requirements are met: a) the device has been CE marked and that the EU declaration of conformity of

the device has been drawn up; b) the device is accompanied by the information to be supplied by the

manufacturer in accordance with Article 10(11); c) for imported devices, the importer has complied with the requirements set

out in Article 13(3); d) that, where applicable, a UDI has been assigned by the manufacturer.

• Distributors may sample• Importers have their own vigilance report and compliance monitoring

requirements• Distributors are any reselling party in the supply chain other than MFR

and IMP

Major overlaps in EO obligations for example in PMS and vigilance

• Account for overlaps in your supply, distribution, agency, etc. agreements

Post-Market Surveillance (PMS) & Vigilance EU MFR Non-EU MFR AR Importer Distributor

Complaint communication within supply chain

Keep register of complaints, non-conforming devicescomplaints, recalls, withdrawals

Inform manufacturer, AR, importer about device non-conformity

Vigilance System

Vigilance Reporting2

Provide documentation demonstrating devicecompliance to Competent Authority (CA)

Provide product samples free of charge to CA

Provide information on serious risks of device toauthoritiesProvide Notified Body with information on serious riskdevicesImplement FSCAs

Cooperation with authorities on FSCAs

Overlaps in comformity obligations

Device conformity MFR Non-EU MFR

AR Importer Distributor

QMS pursuant to MDR / IVDR (Article 10 (9))Person responsible for regulatory complianceQMS according to Article 16 (3) 2nd subparagraph asapplicableEnsure proper device storage and transportConformity assessment including CE-certificateVerification of appropriate conformity assessmentprocedureVerify CE-markingKeep copy of CE-certificateUDI assignmentVerify UDI assignmentDraw up Technical Documentation and keep it available10/15 years

Verification of Technical Documentation availabilityKeep copy of Technical DocumentationDraw up of Declaration of Conformity and keep itavailable 10/15 years

Verification of availability of Declaration of ConformityKeep Declaration of Conformity available

• More sets of overlaps like this, e.g. in labeling, UDI and (product) liability

Please do not end up here