EU Update: MDD & IVDD

Glen Emelock Senior Partner

The CRO Group, Inc. www.crogroup.com

Topics

• MDD Update – Issues and Changes

– EN IEC 60601-1:2006 and -2-xx

– 2007/47/EC Major Changes Mandatory

– ROHS – 2011/65/EU

– E-Labeling

– Directive Recast

• IVDD Update – Directive Recast

MDD – 2011 Issues & Changes

• Harmonised standards updated 15 Nov 2011

– EN ISO 13408-x: Aseptic processing of health care products: 2011 replaces EN 13824:2004 on 31 Dec 2011

– EN 13976 – Transportation of Incubators

2011 replaced 2003 on 30 Nov 2011

– EN IEC 60601 – the saga continues

• EN IEC 60601-1:Electromedical Safety: 2006 replaces 1990 on 1 June 2012 if….

EN IEC 60601-1:2006

• 2006 replaces 1990 on 1 June 2012 if….

– A “part 2” is not applicable

– A “part 2” (to either 60601, 80601) OR EN ISO comes AFTER, is applicable, and refers to 60601:2006

• Example: EN IEC 60601-2-37:2008 by 1 OCT 2010

• Example: EN ISO 15004-1:2009 by 21 MAR 2010

EN IEC 60601-1:2006

• 2006 replaces 1990 on 1 June 2012 if….

– Your Notified Body considers 2006 requirements applicable and constitute “state of the art” under the MDD:

• Home use

• EUMDV reports where one or more of 693 new requirements impacted

• Depending on timing of (3 year) recert product reviews

Your NB Considers 2006 applicable

NOW WHAT?

Get R&D or a 60601 Expert Consultant involved:

• When was it designed?

• Is there a Risk Management File?

• Is there a special intended use/environment? (ex. home)

Your NB Considers 2006 applicable

NOW WHAT?

Get R&D or a 60601 Expert Consultant involved:

• Do a Gap Analysis of the new standard

• Gap Analysis will help determine if added testing is needed

• If testing is needed, scope out test labs NOW – Test Queues building

– Does the Lab need Accreditation?

– Is the Lab Ready to test to the 2006 standard

Your NB Considers 2006 applicable

Suppose it doesn’t pass additional testing?

Get Management involved:

• Components/circuits which will not meet 2006 require replacement?

But wait! Our existing cert expires AFTER 1 JUN 2012

• It may not matter…NB MAY WITHDRAW CERTIFICATE

• Meet with NB/CA – Risk/Benefit of Discontinuing vs. Availability of Nonconforming (but life saving/unique)

• Logistics

Your NB Considers 2006 applicable

But we’re AIMD, so we’re in the clear, right?

Is there an external device to Active Implantable (AI)?

• Programmer (for patients and physicians),

• Speech processor (cochlear implants),

• Ext. power supply for AI

• Ext. pumps to AI circulatory support systems

And Now…the Rest of the World

FDA: • 2006 replaces 1990 on 31 June 2013 for new submissions

“FDA UPDATE 2011” related link #1

Health Canada: • 2006 replaces 1990 on 1 June 2012 for new submissions

RCBS (Republic of CB Scheme): • Can use now. Haven’t decided when mandatory.

Some devices need to meet 2006 now

• EU Harmonised standards updated 15 Nov 2011 EN IEC 60601- -1-3 Radiation protection, diagnostic X-ray 1994>2008 (1 JUN 2012) -1-8 Alarm Systems 2004>2007 (1 JUN 2012) -2-2 HF Surgical 2007>2009 (1 APR 2012) -2-19 Infant Incubators 1996>2009 (1 APR 2012) -2-21 Infant Radiant Warmers 1994>2009 (1 APR 2012) -2-29 Radiotherapy Simulators 1999>2008 (1 NOV 2011) -2-37 Ultrasound Dx/Monitoring 2001>2008 (1 OCT 2010) -2-39 Peritoneal Dialysis 1999>2008 (1 MAR 2011) -2-44 CT X-Ray 2001>2009 (1 MAY 2012) -2-50 Infant Phototherapy 2002>2009 (1 MAY 2012)

MDD – 2011 Issues & Changes

• Harmonised standards – objections continue

– ISO 14971 Challenge

• Requires MORE than MDD specifies

– ISO 13485 Challenge

• SWEDEN: May NOT require ENOUGH

– European Commission has received objections to 9 other standards

MDD – 2011 Issues & Changes

• Borderline and Classification Device Guidance

• 2007/47/EC Major Changes Mandatory

• ROHS – 2011/65/EU

• E-Labeling

• MDD Recast

Borderline & Classification Manual

• Biofunctional clothes – may be Class III if intended to administer medicinal

• Eyedrops for physical (ie: lubrication) use – IIA (short) or IIB (long) duration

• Wound treatment administers anti-microbial (silver, peroxide) – Class III irrespective of the amount of the agent to act on the body

• Contact lenses – Overnight wear IIA, 30 Day wear IIB

• PACS – Class I unless drive/influence source device (same class IIA/IIB), or

– Class IIA if provide direct diagnosis, or

– With image enhance (same as Class IIA/IIB imaging device)

2007/47/EC Major Changes Mandatory

• Clinical data required for ALL classes Annex X

• Class IM/IS (now) permitted to follow Annex II

• Retention mfg records: 5 years or lifetime

• Software as a standalone medical device classed as ACTIVE (web and mobi apps)

– Ex. MDDS (FDA Update 2011 link #2)

– EN 62304 kicks in – “must be validated according to state of the art”

2007/47/EC Major Changes Mandatory

• Devices containing phthalates requirements

• Definition of single use

• Definition of continuous use

• Post Market Surveillance

• Usability Engineering

• NB sampling of similar tech files

• And several more…

MDD – 2011 Issues & Changes

• ROHS – 2011/65/EU – Finally applies to medical devices

• E-Labeling – Draft regulation circulated for review – Expected transition starts 2013

• Until then, NB’s likely to “respect the leaflet”

– Scope: • Standalone software • For exclusive pro (non-lay) use • Used in same non-mobile facility • Installed (non-portable) or implanted

MDD Recast

• New Legislative Framework (NLF) – the modernisation of New Approach Directives

• MDD & AIMD merge into one

• Intended to address myriad of IVD products/issues AFTER MDD:

– Mobile Medical Apps

– Remote (Net) Diagnosis/Treatment

• Notified Body Consistancies

MDD Recast

• Timelines (anyone’s guess after 2012)

– Impact assessment: Sept 2011

– Commission proposals: 1st 1/2 2012

– Legislative procedure: 2014

– Transposition by member states: 2015

– Transition period: 2016-2018

IVDD Recast

• Annex II replaced with Class I, II, III

• Intended to address myriad of IVD products/issues AFTER IVDD:

– Genetic tests by lay-user (baldness marker to HIV)

– Personalised Medicine markers

– Laboratory Developed Tests

– Companion Diagnostics

IVDD Recast

• Timelines (anyone’s guess after 2012)

– Draft Commission proposals: 1st 1/2 2012

– Transposition by member states: 2014-2015

– Transition period: 2015-2016

Wait there’s more

• Not a complete list

• Your NB experience may vary

• Impending Nonconformances may appear larger than they are

• Happy Holidays!

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