MANAGE THE MAID UNDER THE NEW MEDICAL DEVICES REGULATION

The new medical device regulations Capita Selecta: Impact for manufacturers25 March 2013

Erik Vollebregtwww.axonadvocaten.nl

Introduction + agenda

• Understanding how the roles of the economic operators are expected to be defined in the revision of the MDD

• Clarifying autonomous responsibilities of operators in the supply chain of medical devices

• How to implement overlapping responsibilities of economic operators in supply and distribution agreements

Economic operators

The MAID:

• Article 2: ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

Proposal implements strict supply chain control mechanism

• Blueprint from new new approach decision 768/2008• As implemented in other specific instruments, e.g. toys and falsified

medicinal products directive

• Goal: enlist supply chain in market surveillance by imposing autonomous obligations on the various stages of the supply chain

Definition of importer

Article 2 ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market;

‘placing on the market’ means “the first making available of a device, otheran investigational device, on the Union market”;

• placing on the market is neutral as to goods and services, online and offline

Economic operators: importers

Must ensure that: 1. the appropriate conformity assessment procedure has been carried out

by the manufacturer;2. an authorized representative in accordance with Article 9 has been

designated by the manufacturer;3. the EU declaration of conformity and the technical documentation have

been drawn up by the manufacturer;4. the device bears the required CE marking of conformity;5. the device is correctly labeled and accompanied by the required

instructions for use and EU declaration of conformity;6. a Unique Device Identification has been assigned;

Economic operators: importers

Must furthermore: 1. Be able to identify any economic operator to whom they have supplied a

device, any economic operator who has supplied them with a device and any health institution or healthcare professional to whom they have supplied a device for a period of five years;

2. Label the device with their contact details;3. Take corrective action (a.o. recalls and report to authorities)

autonomously;4. Engage in post-market surveillance (among other things report

complaints); and5. Refuse to import devices of which he has reason to believe are not in

conformity with the requirements.

Definition of distributor

Article 2 ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market’

• any natural or legal person in the supply chain

• includes resellers, rental companies• whether online or offline

• that makes a device available on the market

• “any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge”

Economic operators: distributors

Must verify that: 1. the product bears the required CE marking of conformity;2. the product is accompanied by the information to be supplied by the

manufacturer;3. the manufacturer and, where applicable, the importer have complied

UDI and importer labeling requirements

Economic operators: distributors

Must furthermore: 1. ensure that, while a device is under their responsibility, storage or

transport conditions do not jeopardise its compliance with the general safety and performance requirements;

2. Label the device with their contact details;3. Take corrective action (among other things undertake recalls and report

to authorities) autonomously;4. Engage in post-market surveillance and vigilance (i.e., report

complaints)

Overview

Manufacturer Importer Distributor

EndUserPost market surveillance and vigilance

Regulatory compliance of device

Verify compliance Verify compliance

Supplier

Supplier

Subco

ntra

ctor

s

With such supply chain duties, do we still need authorised reps?Yes, AR must at least:

1. keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement issued at the disposal of competent authorities for the applicable period;

2. in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device;

Notably only AR is ‘allowed and required’ to terminate the mandate if the manufacturer acts contrary to his obligations under this Regulation.

Don’t forget to control suppliers and subcontractors upstreamArticle 8 (5) MDR - essentially no changes

Typical means of control is quality agreement

• EN ISO 13485 (management review and purchasing controls)• Annex VIII, 3.2 (b) MDR

• “where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party”

Control has to enable manufacturer to meet QMS goals as well as PMS and vigilance obligations

• Account for unannounced inspections at subcontractors / suppliers

• Manufacturer to

• Issue Subcontrator SOP / Quality Agreement

• criteria for level of control for category of part subcontracted• criteria of level of evidence to be provided by subcontractor• (ISO certificate, DoC, Design, Verification documentation,

documentation on changes)• (periodic) evaluation of part• (periodic) evaluation of subcontractor

• Issue Subcontractor agreement template• Include subcontractors in internal audit program

• Always remember that subcontractors are not subject to same regulatory requirements as manufacturer

Don’t forget to control suppliers and subcontractors upstream

Criticism on supply chain regsCOCIR:

• “several of the described tasks overlap and thus add unnecessary administrative burden with no obvious benefit for the patients.”

• “COCIR suggests that the importer obligations should only apply in situations where there is no organisational or legal relation (contract) between the manufacturer and the importer and the manufacturer has appointed an Authorised Representative in the EU. “

Eucomed:

“It is absolutely essential that the overlapping obligations and responsibilities of different economic operators be clarified in the areas of device registration, vigilance reporting and market surveillance. The definition of clear roles and responsibilities for economic operators is not only critical to the functioning of the system, it is critical to the way the supply chain to hospitals and patients work. If not done correctly, it could have catastrophic effects on certain operators and SMEs within the supply chain, effectively closing their businesses overnight and risking unavailability or increased costs to hospitals and patients.”

Dealing with overlapping responsibilities in supply chain• regulatory compliance upstream

• If importer/distributor considers or has reason to believe that a device is not in conformity, he shall not make the device available on the market until it has been brought into conformity.

• Importer must do sample checks if appropriate regarding to risk

• autonomous post-market surveillance obligations

• If reason to believe that a device is not in conformity: immediately inform the manufacturer and make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken

• immediately forward to manufacturer “complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available”)

Implementation of PMS in supply chainIn addition to the usual provisions account for autonomous obligations on the part of importers and distributors:

• implement mechanism for importer / distributor to check upstream compliance and consequences on both sides

• ensure that manufacturer is always informed of autonomous action undertaken – preferably consulted (implement RACI for autonomous obligations)

• account for consequences of autonomous action

• manufacturer’s reputation is on the line• autonomous action impacts entire supply chain – ensure

appropriate liability and indemnities

• implement mechanism for exchange of PMS relevant information for input in manufacturer processes

Qualified person

Manufacturer must have qualified person (even if manufacturer has AR!) “within their organisation”

• unless SME custom-made devices manufacturer

QP responsibilities:

a) that the conformity of the devices is appropriately assessed before a batch is released;

b) that the technical documentation and the declaration of conformity are drawn up and kept up-to-date;

c) that the reporting obligations in accordance with Articles 61 to 66 are fulfilled;

d) in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued.

Qualified person

QP qualification

• University level in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices; OR

• five years of professional experience in regulatory affairs or in quality management systems relating to medical devices

What do we know?

• Function may be outsourced• Not the same autonomous obligations as AR (terminate / notification) but

is “responsible” – only to manufacturer or also to authorities?• What is a batch? Depends on context and is 1 or more devices

Qualified person

What should an outsourced QP contract contain (from manufacturer perspective)? At least:

• service level / availability• RACI scheme for what is expected on top of “being responsible for” /

signing off on• IP clause• termination assistance• clause to address suspension of services• step in rights• representation and warranties (a.o. as to qualification)• confidentiality clause

Do these clauses work?

So … is this the final word?

• Looks like it – the method chosen for supply chain regulation is the Decision 768/2008 system (articles R4 and R5) which has already been implemented in CE directives (e.g. toys) so fully “new new approach” compliant

Thanks for your attention

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

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