First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

Team-NB is a voluntary organization of Medical Device Notified Bodies (doesn’t represent all EU NB’s under the 3 Medical Device Directives) and as of 12 Nov 2012 there are now 35 members.  During the 9 Oct 2012 Assembly in addition to the adoption of the CoC three (3) new members were unanimously added (LGA InterCert GmbH – Nurnberg Deutschland, UDEM – Ankara Turkey, and ALBERK QA TECKNIC – Istanbul Turkey).

The Version 3.0 Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC, & 98/79/EC is a very thorough document which is 31 pages long and includes the Unannounced Inspections (or Unannounced Audits of Medical Device Manufacturers that are Certified under the applicable Medical Directive) which comes from the recently proposed Medical Device Regulations.  As of the 30 October 2012 News Release 14 Notified Bodies had signed the V3.0 CoC and 2 additional NBs (LNE/G-MED & DQS) signed prior to 12 Nov 2012.  It is anticipated that more NBs will sign in the near future as they adopt the policies covered within the V3.0 CoC which shows their commitment to improve the implementation of the EU CE marking certification of medical devices through clarified organizational criteria, management of competence and assessment practices.  The major topics in the document are:

• Implementation, enforcement and monitoring of the Code of Conduct
• Qualification and Assignment of Notified Body Assessment Personnel
• Minimum time for Notified Body assessments
• Unannounced visits
• Sampling of class IIa and IIb technical files
• Design Dossier Reviews
• Rules for subcontracting
• Rules for Certification Decisions 

Further revisions will be made to be in line with the new developments of the European legislation.

The post on this Commission Regulation (EU) No 722/2012 is thx to Erik Vollebregt who blogs on EU legal and regulatory developments of medical devices.  Erik has provided content previously to our blog and we thank him for his generosity in allowing us to post his content.

“From the Singapore Health Sciences Authority – Updated 2 August 2012 – As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) member states, ASEAN has been working on developing a standardised framework for regulating medical devices that is targeted for implementation by December 2014. 

This draft set of broad principles is called the ASEAN Medical Devices Directive (AMDD), and it is now ready for industry consultation. This published AMDD is not the final version, and there may be changes depending on feedback received from you and other interested parties.

We would like to invite you to provide your feedback on AMDD using this form and send it to HSA_MD_Query@hsa.gov.sg by 31 August 2012. We regret to inform you that we are unable to include any comments received after the deadline for consideration due to time constraints.”

Template for Comments to AMDD due 31 Aug 2012

AMDD – Draft for consultation – 02 Aug 2012

European Commission – Press release

Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants

Brussels, 2 February 2012 – Following today’s publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a “stress test” of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012.

Health and Consumers Commissioner, John Dalli said: “In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case”. To add : “Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased”. To conclude : “We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.

The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon.

Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.

With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

SCENIHR concluded on the basis of available data, that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.

Next steps

First, the European Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States.

Second, the Commission will discuss with the Member States how surveillance of the medical devices can be reinforced immediately within the existing legislative framework. These issues could include further recourse to unannounced inspections, enhanced controls of notified bodies and additional sample testing on products already on the market.

Third, the Commission is also conducting a stress test in order to identify how best the questions raised by this issue can be addressed in the upcoming revision of the legislation on medical devices which was already underway. The Commission still envisages adopting a proposal on the revision of the Medical Devices legislation in the course of this semester.

National health authorities in the Health Security Committee convene by audio conference today to discuss the follow up to the Opinion.

Background

Breast implants fall under the European legislation on medical devices1. This legislation requires that, before placing such devices on the market, the manufacturers must carry out an assessment to ensure that their devices fulfil the relevant legal requirements, and in particular that their devices will not compromise patient safety. For high risk devices, such as breast implants, a third party conformity assessment body, so-called notified body, is involved in the conformity assessment procedure.

In the present case, an investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010.

On the basis of available data, it is estimated that around 400 000 PIP silicone breast implants were sold worldwide. These implants were available in nearly all European Union Member States – in particular they were widely used in the United-Kingdom, France, Spain and Germany, where respectively around 40.000, 30.000, 10.000 and 7.500 women were implanted with PIP silicone breast implants.

Work of the SCENIHR

SCENIHR is an independent advisory body established by the Commission. Its members are chosen on the basis of scientific excellence and they advise the Commission on issues associated with new and emerging health risks.

The current rapid opinion drew on top international scientists’ expertise in fields of plastic surgery, polymer science, senology and medical epidemiology.

To see the full scientific opinion on the safety of PIP breast implants, see

http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm

Link to Medical Devices Directive:

http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

1 :
OJ L 169, 12.7.1993, p. 1