MDD revision receives European Parliament support [more]

MDD reuse controversy resolved? [more]

New FDA statistical guidance on diagnostic tests results [more]

New FDA draft guidance for class III device changes [more]

Change in Daylight Savings Time in the US may affect medical equipment [more]

Health Canada updates list of Recognized Standards [more]

Australian TGA explains rejections of device applications [more]

FDA-style Agency for India? [more]

GHTF Chair passes from EU to North America [more]

Donawa Consulting experts attend numerous conferences and travel globally for business purposes. During these trips they are available to provide company information or consulting expertise. Contact us to arrange a meeting.

TURKEY – Dr. Maria Donawa, President, Donawa Consulting, will visit Turkey on 8 – 11 April 2007 for business meetings. Her schedule includes visits to Istanbul and Ankara.

CHINA – Mr. Roger Gray, Director, European Regulatory Affairs, will visit China from 7 to 16 April. His schedule includes visits to Shanghai and Hangzhou.

BELGIUM – Dr. Monica Tocchi, Director, Clinical Studies & Medical Affairs, will visit Bruxelles on 12 – 13 June 2007 to attend the congress Clinical Evaluation and Investigations for Medical Devices, as an invited speaker. Contact us to participate in the conference at a discounted rate as our host, or to arrange a meeting. Download conference program.

US – Dr. Maria Donawa will be in the US from 5 to 19 May for business meetings in Washington, DC and operating from Donawa Consulting US office in Massachusetts. Contact us to arrange a meeting.

Eucomed, the European Medical Technology Industry Association, has welcomed the European Parliament's support for the review of the Medical Devices Directives. The positive vote came on March 29th, 2007 after the Council, the Commission and the Parliament reached agreement on a number of outstanding issues, including product labelling, classification, reprocessing and transparency. Eucomed commented that the revised text further enhances patient protection without hampering medical progress and innovation.

Guidance documents and secondary legislation will now have to be developed in order to ensure that the new provisions are adequately implemented, especially to evaluate the impact on patient safety of the use of reprocessed 'single use' products, which has caused so much disagreement and controversy over the three years it has taken to bring this revision to the Parliament.

The full text of the revising directive, which will enter into force 20 days after publication in the Official Journal, can be found on the European Parliament website.
 

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It appears that an end to the debate between the European Commission, European Council and European Parliament on the controversial issue of reuse of single-use devices maybe drawing to a compromise solution. News from Brussels indicates that the Commission has been successful in having the subject removed from the MDD revision, but at the cost of having to prepare a separate directive on the topic. This approach seems to have kept all three sides happy, and most probably will allow the planned Parliament vote to go ahead on March 29th.
 
The Commission has always insisted that the framework of the MDD does not allow issues other than the first placing on the market to be regulated, whereas the reprocessing of devices labelled as 'single-use' is to a large extent carried out as a service, without ownership of the items changing.  Despite the fact that the Economic and Social Affairs Committee documented its desire for reuse to be effectively banned under the directive, many MEPs believed that rules should be introduced to require manufacturers to demonstrate that their single-use devices could not be reprocessed safely, much to the consternation of manufacturers, who commented that this was 'having to prove a negative'.
 
The Commission intends to have the new directive adopted by 2010, but it is likely to take the form of a regulation that will only be used as a means of making national legislation consistent in those countries that allow reuse.  Those that do not will be able to continue with an outright ban.
 
The other major stumbling block to the passage of the MDD revision has been the use of 'hazardous substances' in medical devices.  Another compromise appears to have been reached, with agreement on a gradual phasing out of the substances concerned over a five-year period plus specific labelling requirements in the meantime.
 
It is now expected that the Parliament will adopt the proposed revisions without debate, with final adoption now looking promising for May.

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COCIR concerned with potential software standards proliferation

COCIR, the European industry association representing the electromedical device sector, has expressed concern over the number of apparently uncoordinated international standardization projects relating to medical device software, with the potential for conflicting requirements causing confusion for both manufacturers and regulatory authorities.
 
Although an international issue, COCIR intends to bring its concern to the attention of the CEN (European Committee for Standardization) Advisory Board for Health Standards, and is advising its members to influence their national committees to return negative votes on at least two ISO TC 215 new work item proposals (NWIPs) on 'health software'.  These were issued only shortly after publication of a joint ISO TC 210/IEC SC 62A NWIP covering guidance for the application of ISO 14971 on risk management to medical device software.
 
These are in addition to existing requirements for programmable electrical medical systems (PEMS) in the 3rd edition of IEC 60601-1, medical device software life cycle processes in IEC 62304, and FDA device software guidance documents.

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A recent survey by Health First Europe of the EU's healthcare opinion leaders has revealed an unexpected shift towards agreement that there should be a centralised regulatory agency to co-ordinate the European market approval of all healthcare technologies, with 65% of those interviewed being in favour of the concept.

A further surprise comes with the revelation that 41% of the group of 77, selected from MEPs, Commission officials, member permanent representations and healthcare stakeholders, would support the idea of an EU-wide healthcare system in the long-term.

The full report maybe downloaded from www.healthfirsteurope.org.

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EU publishes guideline on IVD instructions

Following several years' negotiation between the European Commission, industry representatives and member states, a new guideline document, MEDDEV. 2.14/3 rev.1, was published in January 2007, entitled 'Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices'.

During the drafting period, this has been known as the 'e-labelling guidance', but this term does not appear anywhere in the paper, although it does advise IVD manufacturers that alternative, non-paper forms of IFUs will in future be allowed under certain circumstances, as will delivery by means other than physically with the device. A decision to use alternate methods must be justified by the manufacturer's risk management process, and reviewed by a Notified Body as part of the conformity assessment process.

Although this guidance applies only to IVDs, it is most likely an indication that similar guidance for devices covered by the other medical device directives will follow in due course.

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ITALY - New device registration procedures and fees from May 1, 2007

An Italian decree approved on 7 March 2007 introduces new procedures for registering medical devices distributed in Italy, into a new databank within the Ministry of Health (MOH) web portal. The purpose of the new system is to improve the previous registration process. The new databank will also be used to generate a complete listing (called “Repertorio”) of devices that are sold to the Italian National Health System. In addition, registration is intended to enhance traceability by assigning a registration number to each device, thereby facilitating MOH market surveillance and vigilance activities.

The new registration requirements apply to medical devices, complete systems and kits (for operating room) and active implantable medical devices already marketed or which will be marketed in Italy. The decree does not cover In Vitro Diagnostic Devices and devices intended for clinical investigations.

Registration fees and sanctions

For companies who wish to participate in tenders to the Italian National Health Service (Servizio Sanitario Nazionale, SSN), the registration in the “Repertorio” will require a fee of 100 Euro for each device or group of devices which share the same technical file. This fee, which is described in the Financial Law of 2007, is due also for devices which are already registered but have undergone modifications which require the transmission of information to the MOH.

Failure to comply with registration requirements will be punished with administrative fines as specified in decree 46/1997 (art. 23, point 4) and decree 332/2000 (art 19, point 3).

Registration timelines

The implementation of the new medical devices databank will be completed in two stages.

• Phase 1, which concerns devices not yet sold in Italy, will begin on 1 May 2007. Manufacturers will need to follow the new registration procedures by accessing the Ministry of Health web portal and transmitting the required information in electronic format.

• Phase 2, which concerns devices already sold in Italy, will begin on 1 January 2009. Manufacturers, which have already registered in accordance with article 13 of the Legislative Decree 46/1997, and which are currently selling medical devices to the SSN, will need to register in the Repertorio. That is, from 1 January 2009, SSN will not be able to purchase, use or provide medical devices that are not registered in the Repertorio.

Additional information, in the Italian language only, is provided on the Italian Ministry of Health website.

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ITALY – Ministry clarifies notification requirements for post-market clinical studies with CE marked devices

The Italian Ministry of Health issued an official notice on the conduct of clinical investigations with CE-marked medical devices that are already on the Italian market. The notice specifies when a notification to the Italian Ministry of Health (MOH) is required and the type of documents that need to be submitted.

A notification is required for any studies of CE-marked devices that have undergone substantial changes or that will be studied for a new indication or intended use. In this case, the notification procedure is the same as that for non-CE marked medical devices.

However, in some cases a notification is required even for CE-marked devices being studied with the same intended use for which they were CE-marked. If the study is conducted in public hospitals, which are part of the National Health System, no notification is needed. However, if the study is conducted in private centres or clinics, the conduct of the study must be authorized by the MOH and a notification needs to be filed. The accreditation of private centres with the National Health Service is not sufficient for performing clinical investigations without the formal, written authorization from the MOH.

This authorization must be requested for each clinical study, it needs to be in the Italian language, and must be submitted to the Ministry along with all the necessary documentation, including a favourable opinion of the Ethics Committee and payment of 1859.25 Euro. The fee is intended to cover the review activities of the MOH. The timeframe for MOH review of the dossiers is 90 days, which is the standard period allotted for activities of the Public Administration.

This notice will have a significant impact on the conduct of post-market clinical studies in Italy. Until now, private centres have been significantly involved in post-market studies including device registries and studies to expand evidence of device performance and safety. Many of these types of studies are currently being conducted and clarifications from the MOH will be needed regarding the status of these studies and the new requirements.

Additional information is available on the Italian MOH website in the Italian language only.

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New FDA statistical guidance on diagnostic tests results

CDRH's Office of Surveillance and Biometrics has announced the publication of a guidance document describing statistically appropriate practices for the reporting of results of different studies that evaluate diagnostic tests where the final result is qualitative (positive or negative).

The document also identifies some common practices that are inappropriate for use and describes a practice that is called "discrepant resolution" and the problems associated with this practice. It does not address fundamental statistical issues that are associated with diagnostic device clinical study design and monitoring.

Initially published in draft form in March 2003, the guidance document represents the FDA's current thinking on reporting results from studies that evaluate diagnostic tests and is issued consistent with FDA's Good Guidance Practices regulation (21 CFR 10.115).

The guidance document addresses the following topics as well as related topics:

• Types of test results

• Purpose of a qualitative diagnostic test

• Benchmarks

• Diagnostic accuracy and the reference standard

• Measures that describe diagnostic accuracy

• Sensitivity and specificity

• Positive and negative predictive value

• Bias

• When a non-reference standard is used for comparison

• Benchmark and Study Population Recommendations

The guidance document may be found at: http://www.fda.gov/cdrh/osb/guidance/1620.html
 

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New FDA draft guidance for class III device changes

CDRH announces the availability of a draft guidance entitled "Draft guidance for Industry and FDA Staff - Modification to Devices Subject to Premarket Approval (PMA). The PMA Supplement Decision-Making Process".

Anyone wishing to make comments and/or suggestions regarding this draft document should submit these within 90 days of publication in the Federal Register.

For a copy of the draft guidance and how to submit comments, click here.

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Change in Daylight Savings Time in the US may affect medical equipment

Daylight Savings Time in the US is three weeks earlier than in past years (March 11).

If medical equipment uses, creates or records time information about a diagnosis or treatment and it has not been updated by the manufacturer, the equipment may function improperly when the new Daylight Savings Time starts.

It is not known what equipment will be affected, if any, how it will be affected, or how it may affect patients. Doctors, Nurses and Hospitals have been notified of this potential by the US FDA.

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Health Canada updates list of recognized standards

The list of medical device voluntary standards recognized by Health Canada has been updated, effective 22 February 2007, adding 27 titles to those previously accepted. The additions to the list originate from ASTM, ANSI, CSA, ISO and IEC, and include a number of specifications for surgical implant materials. Click here to download the new listing.

The guidance document covering the 'Recognition and Use of Standards under the Medical Devices Regulations' was the subject of a minor revision in September 2006. Click here to download the guidance document.

The guidance explains that although conformance with recognized standards is voluntary for manufacturers, as they may elect to address the relevant issues in another manner, if a manufacturer decides to demonstrate conformance with the safety and effectiveness or labelling requirements of the regulations by using one or more recognized standards, a Declaration of Conformity must be submitted with the device licence application. The format for the Declaration is provided on the Health Canada website.

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Australian TGA explains rejections of device applications

The Australian Therapeutic Goods Administration reports that the rate of rejection of medical device applications remains steady at approximately 20% of the total received and has recently published a list of reasons for the rejection to help sponsors determine if their applications are ready for submission.

For Class I, Class IIa and Class IIb the most frequently cited reasons for rejection were: incorrect classification, incorrect GMDN code selection and that the product is required to undergo a Conformity Assessment prior to applicatioin submission.

For Class III and AIMD devices, the most frequently cited reasons for rejection were that the supporting data was not supplied within the specified time-frame, there was a failure to provide key documents and there were problems with the clinical evidence.

For more information, visit the Austrialian TGA webpage: www.tga.gov.au/devices/rejection.htm.

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FDA-style Agency for India

An 18 month joint program with the US FDA has signalled the likelihood of India setting up an Agency to regulate drugs and devices along the lines of the US model.

The proposal has yet to gain parliamentary approval, but the formation of the new Central Drugs Agency now seems likely to proceed to reality.

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GHTF Chair passes from EU to North America

The three-year tenure of EU Commission Director, Georgette Lalis, as chair of the Global Harmonization Task Force (GHTF) has come to an end, with the roatating chairmanship from January 1, 2007 being taken on by Larry Kessler, US FDA's Director of the Office of Science and Engineering Laboratories, Center for Devices & Radiological Health (CDRH).

The U.S. will split the 3-year Charimanship tenure with Health Canada who will take over during the summer of 2008.

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