Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve conference 2013)

‘Potential effects’ of upcoming regulations –

Notified Body implications

Dr. John O Dwyer MD

Qserve Conference

Nov 2013

[email protected]

http://www.nsaiinc.com/services/MedicalDevice/

Medical Device Regulation

More detail in the Regulation than the existing Directives

MDD and AIMDD combined

Detailed and clear rules to allow transparency

Harmonized implementation on designation

Oversight of NBs – third party audits – consistency

with implementing legislation and creating a ‘level

playing field’….

Special Notified Bodies – designation scopes!

General Guidelines for audits & assessments

Annex I - Product Assessment

• Elaborates & enforces current practices

Annex II - Quality Systems

• Recommendation with performing conformity assessments –

elaborates current practices

• Advice on outsourcing & use of subcontractors

Annex III - Unannounced Audits

• New detailed requirements

• Contractual arrangement between NB & manufacturer.

EU document on regulation for NBs

Dependent on the formation of:

• Medical Device Advisory Committee (MDAC),

• Medical Device Coordination Group (MDCG),

• Special Notified Bodies (SNBs),

• Assessment Committee for Medical Devices (ACMD).

Extensive planning and preparation will be necessary.

Representatives from multiple member states will be

required for these groups.

EU Parliament - Key achievements of proposed

Medical Device Regulation

• A new group of bodies, i.e. the Special Notified

Bodies, to assess high-risk devices;

• Tightening up information and ethical requirements for

high risk & diagnostic medical devices used for

example in pregnancy or DNA testing;

• Public access to clinical data for both patients and

health professionals, so that they know better which

product to use;

EU Parliament - Key achievements of proposed

Medical Device Regulation

• Introduction of the patient implant card & registration

of patients therefore alerted if any incidents reported;

• NBs to have a permanent team of in-house experts

who meet up-to-date qualification requirements;

• Persons or institutions who wish to reprocess single-

use devices to be held liable and ensure traceability of

the reprocessed device; and

• A list of devices unsuitable for reprocessing to be set

up via delegated acts.

EU Parliament - Key achievements of proposed

Medical Device Regulation

Proposed IVD Regulation, EP lists the following rules:

• Tighter rules for pregnancy tests, diabetes self-tests

and HIV and DNA tests;

• The setting up of an ethics committee for IVDs;

• Provisions for the informed consent of patients and

genetic counselling.

Implications for NBs!

New requirements for the Designation, scope,

competence and monitoring of NBs

NBs will need to apply and achieve designation

under the new regulation

NB scopes will be specific & based on competence

Certificates issued to be maintained in database

Implications for NBs!

Special NBs for working with high risk devices

Requirement to notify EU Commission and MDCG

of class III new applications

Rotation of members of audit team (less than three

years per auditor)

Un-Announced audits !

Implications for NBs!

Appropriate in-house technical & clinical expertise

Clinical knowledge of the underlying condition/ disease (Anatomy, physiology) and the application of use of the device

Technical knowledge of the relevant technology features, bench testing, risks, design features etc.

Up-to-date knowledge/training of all relevant directives, standards, Meddevs etc.

Implications for NBs!

Active participation in the NB MED meetings, updates, workshops & CoC ?

Auditor resources to perform un-announced audits with detailed plans, procedures etc.

Qualified person available within NB who has medical device expertise

NBs need to be economically viable & indemnified

appropriately.

Implications for clinical reviews ?

Clinical competency & experience with challenging literature reviews – i.e. CER reviews, search methodologies, article reviews etc.

Clinical Knowledge in design, planning, conduct and interpretation of clinical investigations

Competency in reviewing/interpreting PMS & PMCF and with ensuring the ongoing safety & performance of the device is maintained.

In-house NB clinical expertise – e.g. medical doctor

Implications for clinical reviews ?

Clinical expertise to identify and estimate the clinical

risks and the clinical benefit /risk analysis for the

specific device under review.

Clinical expertise in-house to liaise with ‘external’

clinical practicing expert input (e.g. cardiologist) &

with making in-house decisions on review findings

Qualified staff based on NBOG product category

Implications for clinical study reviews ?

Study design – FIM, pilot, pivotal > greater scrutiny?

Sample size justification – robust statistical input to demonstrate safety & performance & dictated by ‘claims’ & indications

Appropriate ‘follow-up timelines’

- to ensure safety & performance are demonstrated

- primary endpoints carefully planned & achieved!

- follow-up should reflect the ‘lifespan’ of the device

Implications for clinical study reviews ?

Clear objectives of Investigation met

Appropriate patient population

Randomisation & controls -‘state of the art’

Comparison type – (superiority, Non-inferiority)

Protocol deviations – will pooling of data be allowed?

Implications for clinical study reviews ?

Clinical Investigations per ISO 14155 (2011) > greater scrutiny

Meddev 2.7.1 rev 3 – clinical evaluation guidance principles may be adopted into regulation ?

Currently demonstrate safety & performance (i.e. conformity with claims of intended use)

May request to demonstrate safety & effectiveness (incl. clinical benefit) > greater study numbers?

Implications for Technical file reviews ?

Technical documentation must demonstrate that the CER, Risk Management file and the IFU all contain statements that are consistent > direct relationship

Low risk devices (class I/IIA) > known & foreseeable clinical risks are identified in CER (pre-mkt) & unforeseen risks in PMS

High risk devices (class IIB/III) > known foreseeable clinical risks identified in CER (pre-mkt) & unforseen risks in PMCF

Thank You

Dr. John O Dwyer MD, MBA

European Manager

Nov 2013

[email protected]

http://www.nsaiinc.com/services/MedicalDevice/