EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation

M5 Amendment of EU Directive 93/42/EEC - regulatory update Jan van Lochem – Gert Bos – Suzanne Halliday 5 November 2009 HKTDC Hong Kong International Medical Devices and Supplies Fair 2009 Seminar “Regulatory update on medical devices in Asia and EU” For more information on healthcare standards visit: http://shop.bsigroup.com/healthcarestandards

Content
1. Revision of the EU medical device directive
2. Implementation of the revised directive
3. Key changes
4. Changes to clinical requirements
5. Introduction of technical file sampling
6. Impact revision on technical or design dossiers

1. Revision of the EU medical device directive

History
“The Commission shall, no later than 5 years from the date of implementation…..submit a report .....and if necessary make appropriate proposals” 93/42 Article 11.4
It was decided that the review should:
Cover all aspects
Be open to all stakeholders

Main Findings of Report
Directives provide appropriate legal framework and, in general, work well
Areas needing improvements:
Conformity assessment
Designation & control NoBos
Clinical data & PMS
Member State resources devoted to implementation
Most areas of improvement could be addressed by guidance

2. Implementation of the revised directive

Timescales for Implementing
2007/47/EC - 5th (M5) amendment of 93/42/EEC http://ec.europa.eu/enterprise/medical_devices/revision_mdd_en.htm
MS required to transpose ‘M5’ into National Laws by 21 December 2008
Manufacturers and NoBo may start to implement
Directive fully enforced in all MS by 21 March 2010 Manufacturers and Notified Bodies must be in compliance

Q&A around amended MDD
Do certificates change after 21 March 2010
2007/47 is amending directive, not stand-alone one
Existing certificates remain valid; no need to re-issue them on 21 March 2010
No need to refer to M5 or 2007/47 on certificates
Do Notified Bodies audit to M5 before March 2010
Raise observations / OFIs rather than non-conformities to cover the additional requirements
Show M4 or M5 as audit basis in Notified Body documents and reports

Q&A around amended MDD
Can Manufacturers use Essential Requirement Checklists including M5 requirements now?
Yes; but they must agree with their Notified Body which versions of their procedures are “official” up to 21 March 2010
Is there a requirement to have had an M5 compliance audit before 21 March 2010?
No; except where a change in classification requires a different conformity route or additional review by NB
After 21 March 2010 all audits must be to 93/42/EEC as amended by 2007/47/EC ie M5

State of play certificate changes
EC Certificates DO NOT need updating to refer to 2007/47/EC
NO assessment required to 2007/47/EC before March 2010 to maintain EC QA Certificates (Annex II, V & VI)
NO requirement to review and update EC Design Dossier Examination Certificates before March 2010
NEW certificate needed in some reclassifications
Evolving guidance, further clarifications expected before March 2010

3. Key changes

Key MDD Changes
Software in definition, single use devices defined
Classification changes, PPE, MD
Alternative labelling (draft directive)
Clinical evaluation
Single authorized rep
Improved communication / Confidentiality
Essential requirements
Quality system & PMS
Techfile sampling

Essential requirements
ER 6a: - always clinical evaluation
ER 7.1: - biophysical modelling introduced
ER 7.4: - major rewording combination products
ER 7.4: - consultation on changes
ER 7.5: - carcinogenic, mutagenic, toxic for reproduction, phthalates (67/548/EEC)
ER 12.1a - Validation of software
ER 13.3 - Authorized representative
ER 13.3 - Single use consistency
ER 13.6 - risks re-use IFU, latest revision IFU

Impact on QA Assessments - General
2007/47 makes some changes to the assessment under the QA modules, eg:
Documentation of control of subcontractors
Procedure for clinical evaluation
Pro-active post market surveillance
BSI already emphasises these points as they are both explicit in ISO 13485 , and active PMS was already identified in ISO 14971 and NB-rec on PMS

Impact on QA Assessments - General
Surveillance audit focuses more on clinical follow-up data, PMS, update risk management file
More audit time expected due to introduction of Technical File sampling class IIa and IIb devices

All Annexes Document Retention Times
What it Says
The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep (records) at the disposal of the national authorities
What it Does
Increases document retention time (in line with ISO 13485)
Distinguishes implants from other products
Appears to be unrelated to product lifetime

Confidentiality
Not treated as confidential:
Name manufacturer / authorized rep
Certificate info including issuance, modifications, suspensions, withdrawals

4. Changes to clinical requirements

Key MDD Changes – clinical
Clearer Definitions (Annex X)
Clinical Data – safety / performance data (literature, market information, clinical investigation)
Clinical Evaluation – review of any type of clinical data
Clinical Investigation – clinical study involving human subjects
Clinical Evaluation of Clinical Data is required for CE Marking
Alignment with MEDDEV 2.7.1 and ISO 14155

Key MDD changes – clinical data

Annex X – Clinical Evaluation
Clinical evaluation for all medical devices
Where demonstration of conformity based on clinical data is not deemed appropriate, compliance to ERs must be justified through risk management output, performance evaluation, bench testing and preclinical evaluation. Reason duly substantiated.
For implants and class III medical devices: clinical evaluation unless…….
Clinical evaluation in technical file (or full reference)
Clinical evaluation and documentation must be actively updated based on PMS data

Clinical investigations
Data relating to clinical investigation in Europe in European database
Any interruption, modification, refusal of clinical investigation in EU member states communicated to other Member States in the EU

5. Introduction of technical file sampling

Key MDD changes TF sampling IIa and IIb Devices
What it Says
For devices in Class IIa the notified body shall assess …… the technical documentation … for at least one representative sample for each device subcategory ….
For devices in Class IIb the notified body shall assess ….. The technical documentation … for at least one representative sample for each generic device group …
What it Does
Sets out different sampling regimes for Class IIa and Class IIb
Derived from GMDN terminology (BS EN ISO 15445:2000)
GMDN definitions are reproduced in Article 1

Key MDD Changes – Definitions
‘device subcategory’ means a set of devices having common areas of intended use or common technology (class IIa)
‘generic device group’ means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics (class IIb) Critical for sampling of IIa and IIb technical documentation

GMDN – a method of grouping devices

Technical Documentation Sampling by Notified Bodies
Incorporated in audit plan Notified Bodies, extra audit time
Already a MEDDEV 2.10 “requirement”
Adds similar sampling under Annex V and VI
Defines sampling regimes
NBOG Guidance 2009-4 (July 2009) applicable

BSI approach to sampling
Sampling regimes will be based on rationale agreed with manufacturer
BSI objective is to deliver required increased scrutiny in a pragmatic and practical way
Class IIa
Based on “subcategories” identified in manufacturer scope on certificate
Use of NBOG guidance 2009-3 on product categories
Class IIb
Manufacturer starts from GMDN generic device group definitions
BSI, in agreement with manufacturer, rationalises down to representative samples

Class IIa – Device subcategory

Latest NBOG Guidance on TF sampling, reduced sampling numbers
For Class IIb devices: sample of generic device groups, referenced by different GMDN preferred terms, to following plan:
Up to 2 groups: a sample from each group
Up to 10 groups: a sample from 3 (was 6) of these groups
Up to 20 groups: a sample from 5 (was 7) of these groups
Up to 30 groups: from 7 (was 8) groups a sample
N > 30 groups: from N/10 + 5 groups a sample

Sampling –BSI approach
Class IIa devices: a sample of each group over a 5 year period.
Class IIb devices: determine sample plan for a 5 year period.
The Sampling plan updated periodically, at least each 3 years.

Depth of Assessment of Technical Files
Not full Design Dossier review, but it will cover “essentials”
No differentiation between Class IIa and IIb
Guidance from NBOG indicates that assessment of each set of technical documentation should consist of review of:
classification
validity of essential requirements checklist
risk management
pre-clinical data (studies in animal models, biocompatibility, nanotechnology etc.)
clinical data (Note NoBo review as per MEDDEV 2.7.1)
declaration of conformity, and
other technical documentation based on risk

Sampling conclusions
Major new requirement for Annex V: involvement NB in review of technical documentation
Sampling regime
Depth review based on NBOG guidance
NBs need to agree sampling regimes with manufacturers as soon as possible
Major new requirement for both NoBo and manufacturers

6. Impact revision on technical or design dossiers

2007/47/EC Impact on Technical Documentation
Notified Bodies, Manufacturers - Full Compliance Required by 21 March 2010
Transition started December 2008
New ER’s & Clinical Evaluation Requirements
Proactive Review of Amendments by Manufacturer
Impact on Technical Documentation & DoC
Confirmation Amendments Have Been Considered and if Appropriate Addressed
By Product or Manufacturers’ Full Scope, as Appropriate

Design Examination or Type Examination Certificates
Manufacturer updates DoC to reference 2007/47/EC amendments when satisfied that product complies
NB will review compliance with modified Directive during Design Dossier renewals / changes and audits after 21 March 2010
Irrespective manufacturer is responsible for ensuring full compliance with 2007/47/EC amendments from 21 March 2010

2007/47/EC Clarifications on Technical Documentation
Annex II Technical Documentation
A statement indicating whether or not the device is manufactured utilizing tissues of animal origin as referred to in Commission Directive 2003/32/EC
Annex II, V & VI Technical Documentation
The solutions adopted as referred to in Annex I Section I (2),
the preclinical evaluation,
the clinical evaluation referred to in Annex X
Annex X
Confirm that plan for post market clinical follow-up exists and is acted upon and justification for no post market clinical follow-up is documented

Summary
March 2010 full compliance required
No effect on classification?
5 year sampling plans agreed with Notified Body
Labelling checked and updated
Devices already on the market
Devices in stock
Updated technical documentation
Update declarations of conformity

What is next?
In June 2008, EC started recast
Significant revision of legal framework proposed
Converge on global model
Harmonize on national differences, reduce fragmentation
Strengthen clinical requirements
Harmonization quality and oversight Notified Bodies
Adapt to new technologies
Involve possible EMEA for high risk devices
EC preparing next steps, talking to stakeholders

Relevant links
Website European Commission (new 28 October 2009):
http://ec.europa.eu/enterprise/sectors/medicaldevices/index_en.htm
Website NBOG:
http://www.nbog.eu/

For more information on healthcare standards visit: http://shop.bsigroup.com/healthcarestandards

EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation

by BSI British Standards Institution on May 19, 2010

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EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation — Presentation Transcript