IMDRF Update – from today’s Sydney Open Session meeting
The new International Medical Device Regulatory Forum (IMDRF) holds its second full meeting in Sydney this week. Today was the Open Forum day – attended by industry delegates and other stakeholders. Here’s a summary of the key points of the day.
Membership remains as the GHTF five plus Brazil and the WHO. Notably China attended as observers in Sydney with Russia “keen” to come on board.
AHWP Chair calls for “Full partnership”
AHWP are observers at IMDRF. In an impassioned speech, AHWP Chair, Saudi FDA’s Dr Saleh Al Tayyar threw down the gauntlet – arguing that AHWP must be seen as a full partner – with observer status not enough.
The regulators are clearly setting the Agenda – IMDRF Chair Larry Kelly explained that Working Groups will tend to begin as regulator only membership –but once the remit has been established, broader membership will be invited whenever that makes sense. More of that below.
Down to Business
Certainly IMDRF has wasted no time in getting down to business with five working groups commissioned with practical objectives. Larry Kelly explained that IMDRF will break with the GHTF tradition of standing sub committees with broad remit. Rather the focus will be on Working Groups established with tightly focussed objectives which will only exist for the lifetime of the particular project. The Working groups have been tasked with some grand visions, yet at the same time each has picked an achieveable and meaningful first target – clearly IMDRF is setting out to achieve some early wins.
WG1 Review of NCAR (Postmarket reporting) system – early days yet.
This group is limited to Regulatory Agencies only but including many outside of IMDRF, the only proviso being that the agency be trained in the NCAR reporting processes. To date some 250 reports have been exchanged. Having said that – 250 is a tiny proportion of the many thousands of events reported to global regulators – it’s early days yet but it’s not yet clear if this formal reporting arrangement will add anything – manufacturers are already required to advise all markets supplied if a problem arises and regulators have always had back channels of communication when something really important happens.
WG2 Roadmap for UDI – no more tower of Babel?
This group has set an ambitious target of building the basic structure for Universal Device Identifiers for 5 subgroups of devices over the next two years. The Group is using the HL7 electronic record standards to attain interoperability of jurisdictional databases and wants to learn to walk before it tries to run – deliberately keeping the first iterations as simple as possible. The Aim to establish database rules by March 2013 for Capital Equipment, non IVD devices and for direct marking of implants, with IVDs and software to follow a year later. However it was pointed out that both Europe and the US have even more aggressive timelines – leaving open the possibility of diversion from the consensus approach being developed at IMDRF.
WG3 Medical Device Single Audit Program MDSAP – one audit for all markets?
First consultation draft to be released in Sydney.
WG chair FDA’s Kim Trautmann explained that this group has picked accreditation standards for 3rd party assessors as its first priority. The group has drawn widely on the assessment and accreditation regimes in member jurisdictions and is working toward a common approach – see below for current developments in both Europe and IUUS which are opening up a path to at least a US-Europe alignment on registrar accreditations. Watch the IMDRF website for a first consultation draft due out after the Sydney meeting on 27 September.
Responding to a question from GMTA Vice Chair Michael Gropp, Trautmann foreshadowed the WG moving on to looking at audit practice and particularly at approaches which focused on product safety improvement rather than simple compliance.
WG4 A catalog of Recognized standards – surprising lack of consensus
This WG is charged with taking a snapshot of the recognized standards in use in IMDRF jurisdictions. Collating the ISO and CEN standards sets has been straightforward – identifying all the industry standards has been much more challenging. So far more than 450 separate standards have been identified. What was surprising was the lack of overlap – with almost no standards recognized universally. The group aims to wind up in 2013 with publication of a comprehensive list of standards.
WG5 Regulated Product Submission – One size fits all?
This group is working towards a framework for regulatory submission/dossiers which goes far beyond the current STED/CSDT formats – bringing medical devices towards the detailed specifications seen in the ICH Common Technical Dossier (CTD) established for drug submissions. Indeed Larry Kelly observed that the objective is to seek a format that would work across multiple product types and easily accommodate combination products. The group is also looking at electronic data structures and other options to ease e-submissions. It’s a big ambition, but if successful has the potential to revolutionize the management of Technical Files – with the promise of a truly global Technical File and dossier structure.
Each of the current IMDRF members provided updates on current developments in their own backyards – there’s a huge amount of change in the air.
TGA –Australian Reform Agenda continues –
Stronger regulation of Class III devices, publication of specific device names on the ARTG.
TGA devices head Andrea Kunca – referred to the two key documents setting out the road map for the current TGA reform program – the 2011 “TGA Blueprint” and the recent Australian Federal Government Response to the Senate Enquiry into TGA regulation of devices . The TGA reform Agenda is extensive, with union with New Zealand also back on the Agenda. The pressure is still on to strengthen regulation of high risk devices – watch out for a TGA consultation paper before years end. Also high on the Agenda is opening up the Australian Register of Therapeutic Goods and including specific product names against the generic entries currently visible on the public ARTG site. Again TGA expects to publish their proposals soon.
GMP regulations harmonized with Mercosur
Big changes in South America continue to emerge with new Brazilian regulations setting out detailed requirements for specified devices – including needles, syringes, and silicone breasts. Brazil has also published an updated GMP regulation – bringing Brazil into line with the 2011 Mercosur GMP requirements (in Spanish).
GHTF IVD STED adopted, review performance figures to be published.
Canada has been working on updating IVD requirements- now adopting the GHTF IVD STED for Canadian submissions. Health Canada has also been busy adjusting the risk scheduling for domestic inspection cycles for Class I devices with manufacturers to be inspected every 3 years, Importers every 4 years and distributors every 5 years.
Health Canada will commence publication of review timeline performance commencing Nobvember 2012.
New Device Regulations to replace Directives
It’s a red letter day in Europe with announcement of th e publication of new draft regulations coinciding with the Sydney meeting. The Commission will today release drafts of two new regulations, one for Devices one for IVDs, to replace the MDD/AIMD/IVDD directives.
If the European process runs smoothly (that’s a big IF of course) these Regulations could become Law within 15-18 months with a possible transitional implementation period.
Highlights of the new regulations are:
- Scope is broadened including explicit inclusion of cosmetic devices
- Inclusion of Rules on reprocessed Single Use Devices. Consider ar manufacturer, ban for some critical devices, members states may be allowed to imposer stricter rules/bans.
- Adjustment of Classifications and adoption of the GHTF classification system for IVDs
- Stricter responsibilities for manufacturers and suppliers including the requirement for employment of a “Qualified Person” with specific expertise and qualifications related to device safety. And direct responsibilities for product release and conformity.
- Single registration of all devices and representatives for all of Europe – replacing the existing multiple national registrations. With the database open to professionals and the public. This database will develop to include use of the UDI and a single European reporting of adverse events
- Beefed up requirements for Notified Bodies – with new tougher accreditation rules and a requiremenmt for reapplication under the new regulations, with no grandfathering provisions. Designations will be jointly managed between member states and a Commission auditor. These rules are expected to result in many reductions in scope or losses of accreditation leaving fewer Notified Bodies.
- Scrutiny of high risk devices. A new Mechanism for member states to call in a file for particular device with possible joint review across all States
- Tougher audit practice – with mandatory unannounced audits and rotation of auditors,
- Introduction of European IVD reference laboratories
- Beefed up requirements for clinical data.
EC moving ahead on strengthening of Notified Body Supervision
The Commission is not waiting for the new regulations to tighten up supervision of Notified Bodies – asking member states to review all current designations of Notified Bodies, reporting back by end of September. This may soon result in withdrawal or curtailment of some accreditations.
Member states have been asked to request Notified Bodies to do unannounced audits, and to consider conducting market sampling and testing.
Third party assessment of Class III devices on the horizon
Japan’s Cabinet recently released a Life and Innovation 5 year plan. This national blueprint includes establishment of a new medical Device Chapter in the Japanes Pharnaceutical Affairs Law (PAL) completing the separation of medical devices from medicines. Included in this reform is a move to allow 3rd Party assessment of high risk Class III devices – extending beyond the current limited system for Class II devices. The regulatory re-write will also include for the first time specific requirements for medical software – currently missing from Japanese requirements.
Alignment with EC for accreditation of third party assessors?
FDA’s Jeffrey Shuren outlined a “busy year in the US” pointing to the User Fee reauthorization – boosting fees in return for a commitment to “more robust” FDA review performance from October 1. And the FDA’s regulatory science initiative. Shuren highlighted FDA’s intended transition to a patient centred framework for PMA reviews to include greater interface with patient groups to inform the agency of patient perspectives on risk and benefit, and upgrade of the de novo process for Class II devices.
The US Congress has directed FDA to establish explicit criteria for reaccreditation of 3rd party reviewers. Shuren pointed to the current focus on the Single audit program in IMDRF (under US FDA lead) and keen FDA interest in Euuropean developments on Notified Body accreditation, alluding to possible Europe – US alignment on accreditation of 3rd Parties – which may open the door to a much expanded 3rd party review and audit program in the US.
Reforms of FDA review of pivotal clinical trials will allow companies to seek FDA guidance and obtain written confirmation from FDA on the suitability of the protocol to support future PMA submission.