2007-47-EEC - Rev MDD

2007/47/EC

Amending 90/385/EEC (AIMD), 93/42/EEC (MDD) & 98/8/EC (Biocidal Products)

Contents of Presentation

Structure of the New Directive Overview of Revision Impact on Manufacturers Other Changes Summary

Structure of Directive

2007/47/EC - Contents

Whereas : Reasons for changes Article 1 : Changes to 90/385/EEC (AIMD) Article 2 : Changes to 93/42/EEC (MDD) Article 3 : Addition to 98/8/EC (biocidal) Article 4 : Adoption 21-Mar-10 Article 5 : Into force (20th day after OJ) Article 6 : Addressed to Member States

2007/47/EC - Annexes

Annex I amends 90/385/EC Annexes 1-7 Annex II amends 93/42/EEC Annexes I-X

Overview of Revisions

Purpose of Revision

Better specify obligations of key players Manufacturers, Notified Bodies & Authorities

Ensure highest level of safety

Support the legal framework Transparency

EU part of global activities on regulatory convergence – GHTF

Emphasis on Key Issues

Clinical Evaluation

Conformity Assessment

Post Market Surveillance

Definitions

Medical Device (Revised) software specifically for diagnosis &/or therapeutic

purposes Clinical Data – (New)

IMPORTANT, see also Article 15 & Annex X Additional New Definitions

Device subcategory Generic device group Single use device

Implementation Timelines

Publication Transposition by Member

States Implementation EU Databank (eudamed)

Other: MedDev 2.12/2 Vigilance

Sept. 2007 By Dec. 2008

From Mar. 2010 5 Sep. 2012

Jan. 2008

MDD Changes

More of a clarification on many issues Some significant changes

Whole area of Clinical EvaluationPost-Market SurveillanceReclassification of some DevicesTransparency & Co-operation

Impact on Manufacturers

Impact for ManufacturersANALYSIS of PRODUCT

and its FEATURES

IDENTIFY APPLICABLEESSENTIAL REQUIREMENTS

CLASSIFICATIONof PRODUCTS

CONFORMITY to E.R.:STANDARDS, OTHER

TECHNICAL DOCUMENTATIONCONFORMITYASSESSMENT

CHOICE of CONFORMITYASSESSMENT ROUTE

00500050

Is my product a MEDICAL DEVICE?

What CLASS is my device?

What do I do to put CE on my device?How do I show conformity of my device?

Which Requirements apply to my device?

Is my Product a Medical Device?

Definition of Medical Device

Demarcation – other directives

Changes?

Medical Device Definition

any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of ….. (Article 1. 2(a))

Scope of Directive

Device can be both MDD & PPE (Article 1. 6)

Drug/Device?Principle Mode of action taken into account.

(Article 1 5(c)) PHYSICAL action = Device PHARMACOLOGICAL action = Drug

MEDDEV 2.1/3 rev2http://ec.europa.eu/enterprise/medical_devices/meddev/2_1_3____07-2001.pdf


and its FEATURES










What Class is my Product?

Classification Rules – Annex IX

Changes?

Classification Rules

Software – considered ‘Active Device’ (Annex IX 1.4)

(Rules 9 – 12 apply) Central Circulatory System – Extended (Annex IX 1.7)

arcus aorta & aorta descendens to the bifurcatio aortae now included – CCS : Class III

Duration of use – May be extended (Annex IX 2.6)

If device discontinued and replaced immediately by the same/identical device, consider as extension

Classification Rules (cont.)

Rule 5 – Invasive with respect to a body orifice Now includes connection to active device

Rule 6 – Surgically invasive, transient use Now includes contact with CNS : Class III

Rule 15 – Disinfecting/Cleaning/Rinsing If disinfecting invasive devices, now Class IIb

Rule 16 – Recording X-Ray Diagnostic Images removed term “non-active”

Note:

Proposal regarding reusable surgical instruments was NOT adopted.


and its FEATURES










How do I place CE on my device?

Conformity Assessment Routes

Registration

Conformity Assessment Routes

Only 1 Significant Change :Annex II now a Valid Route for Class I Sterile

or with Measuring Function. (Annex VII 5)

Registration

Article 14 – Single Authorized Rep mandatory if manufacturer outside of the EU.


and its FEATURES










Which Requirements Apply to my Device? Changes in Annex I – Essential

Requirements (E.R.)

Relationship with other DirectivesPPE – E.R. from 89/686/EEC (Article 1 (6))

Machinery – E.R. from 2006/42/EC (Article 3)

Essential Requirements changes

1. General (Safety) Requirement – add:This shall include:Reducing, as far as possible, the risk of use

error due to ergonomics/environment used (design for patient safety)

Consideration of technical knowledge, experience, education & training, also medical/physical conditions of intended users (design for lay/professional/disabled or other)

E.R. Changes (cont.)

6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X

7.1 Validity of biophysical or modelling research demonstrated beforehand


7.4 Hazardous SubstancesDirective 2001/83/EC replaces 65/65/EECMedicinal: Notified Body seek opinion from

Competent Authority (CA) or EMEAHuman blood: seek opinion from EMEAChanges made to manufacturing process –

consult with CA to confirm Quality & Safety maintained


7.5 Substances LeakingSpecial attention to carcinogenic, mutagenic

or toxic to reproduction – Annex I 67/548/EECPhthalates – labeledTreating children/pregnant/nursing women,

specific justification for use & IFU


12.1a – Software validation (new) 13.3f – Indication of single use must be

consistent across the Community 13.3h – If single use, include why not to

re-use in IFU : if no IFU make available on request

13.6q – Date of issue/rev. on IFU


and its FEATURES










How do I show Conformity?

Changes to Technical Documentation Clinical Evaluation Quality System Requirements

Technical Documentation

Declaration of Conformity Covers one or more medical devices Clearly identified (name, code, unambiguous ref.)

Documentation includes Intended use Statement regarding tissues of animal origin Pre-Clinical & Clinical Evaluation (see Clinical Data!)

Annex VIII Statement more defined(Custom made/for Clinical Investigations)

Clinical Data – New Definition

the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from: clinical investigation (s) of the device concerned; or clinical investigation (s) or other studies reported in the

scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Clinical Evaluation – Annex X

Confirmation of conformity with ER 1 & 3 under normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio in ER 6 must be based on clinical data.


The evaluation of this data (‘clinical evaluation’) must follow a defined and methodologically sound procedure based on either: a) A critical evaluation of the relevant scientific literature

currently available relating to the safety, performance, design characteristics and intended purpose of the device (demonstration of equivalance of the device and the data adequately demonstrates compliance with the relevant ERs),

b) Or a critical evaluation of the results of all the clinical investigations made,

c) Or a critical evaluation of the combined clinical data in a) & b) above


For implantable & Class III devices, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up (part of the post-market surveillance plan) is not deemed necessary, this must be duly justified and documented.


Where demonstration of conformity with ERs based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

Clinical Data

Clinical Evaluation & Outcome Documented Included in Technical Documentation Also references in Annexes II-VII to Post

Market Surveillance including provisions of Annex X

ER 14 replaced by ER 6a – NO exceptions

Clinical Investigation

Review of Clinical Investigation Plan If refused/halted by Member State – they

communicate decision & grounds to all. Manufacturer advises when investigation

ends. If terminated early – justification & communicated to all.

Clinical Investigation (cont.)

Annex VIII – Statement Investigator’s brochure Confirmation of insurance of subjects Documentation to obtain informed consent Statement regarding medicinal/human blood & tissues

of animal origin Annex X – adverse event reporting

ALL serious adverse events, whether device related or not.

Quality System Requirements

Documents & Records to be retained for5 years15 years if Implantable Device

Methods for the control of outsourced processes – design &/or manufacturingMust be documented

Other Changes

Thank You

2007-47-EEC - Rev MDD

Documents

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