News
Aug 2009
Monthly News - Device & Service Regulations |
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The UK Notified Body BSI is strengthening its medical device team with the addition of two new well known medtech experts: Gert Bos, who will take up his position as head of regulatory and clinical affairs on September 1st and Sue Spencer who will become head of IVD on the same date.
The brief of Dr. Bos who has worked as principal certification manager and technology manager for medical devices at KEMA, will be to strengthen BSI's role in the regulatory work at EU level in Brussels, supporting complex drug-device and animal tissue combination projects and increase BSI's competence in the evaluation of clinical data.
Mrs Spencer has a brief to set up an expert, quick response, full accredited IVD Notified Body in BSI to serve IVD manufacturers globally.
Source: Clinica Magazine 1347 Aug 21 2009
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The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued draft guidance to manufacturers on the notification of adverse incidents involving neurostimulators. The guidance aims to "facilitate the uniform application and implementation" of medical devices directive 93/42/EEC, and is supplementary to the European Commission guidelines on the medical devices vigilance system and associated MHRA guidance. The consultation ends September 30 2009.
Source: Clinica Magazine 1347 Aug 21 2009
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To help manufacturers of devices containing certain phthalates comply with the new labeling requirements of the revised Medical Devices Directives (MDD), Eucomed has released proposed symbols that can be used until an official labeling standard is adopted.
The MDD, which goes into effect March 21, 2010, requires specific labeling when phthalates that are classified as carcinogenic, mutagenic or toxic to reproduction are an integral part of a device intended to administer or remove medicines, body fluids or other substances, or intended to transport and store such fluids or substances, Eucomed says in a statement posted recently on its website.
Plasticizers that must be identified include bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP), which have been classified in the EU as toxic for reproduction.
http://www.eucomed.org
Source: FDA Device News EBulletin 21 Aug 09
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NICE has been asked by the Department of Health to coordinate the evaluation of innovative medical devices and diagnostics used in the NHS. The new work programme follows recognition in Lord Darzi’s Next Stage Review of the need to improve the process of identifying, evaluating and adopting effective new medical devices and diagnostics.
The evaluation pathway will be used to identify medical devices and diagnostics for national evaluation where it is believed that following evaluation they have the potential to offer substantial benefit to patients and/or the NHS and are more likely to be adopted more consistently and more rapidly. Some of these products will be new while others will already be in use but not in widespread or consistent use.
Andrew Dillon, NICE Chief Executive, said: “We are at the early stages of setting up this programme and are wor king with the medical devices and diagnostic industries, as well as our partners in the NHS, to ensure that what we do and how we do it is closely aligned with the needs of all our stakeholders. This is a new initiative for NICE that will play to our key strengths of producing the best quality advice based on the most up-to-date evidence. It’s good news for patients and manufacturers, as well as the NHS because it will drive the adoption and diffusion of innovative medical technologies more quickly and simply and deliver improved efficiency and value for money.
“In addition, we hope that the evaluation pathway will provide an opportunity for collaborative (NHS and industry) research to generate clinical effectiveness data on innovative technologies where this is needed.”
The programme will provide a coordinated suite of guidance and advice on the clinically effective, cost-effective and efficient use of selected technologies. It will include an implementation component to facilitate and accelerate uptake of appropriate innovative technologies and ensure more consistent diffusion across services. A key element of the programme will be the establishment of an independent Medical Technologies Advisory Committee (MTAC). The Committee, for which recruitment is currently underway, will have three distinct functions:
- Selecting products for evaluation and routing them through one of the available evaluative routes (initially the NICE technology appraisal, interventional procedures or the soon to be launched diagnostics programmes – evaluation programmes from different organisations will be added to the pathway at a later date)
- Undertaking evaluations on medical devices (all diagnostic products will be dealt with through the new diagnostics programme) with an emerging or ‘thin’ evidence base
- For a small number of topics, recommending further research, using pre-determined options.
The Committee will hold its first meeting in November 2009.
Source: nice.org.uk/newsroom
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There has been much confusion in recent times around the official definition of an SME, specifically regarding the turnover figure. For many companies understanding the definition is vital, as it siginificantly impacts their ability to apply for funding and opportunities. My M-Link is delighted to advise that we have official confirmation of the current definition, and suspect that some of you who may believe you had fallen out of the definition, can count yourselves back in!
The current definition of an SME is:
250 Employees of less
No more than 25% owned by any other company
Turnover of less than 50million EUROS - for this year that equates to around £48million GBP. (Previously the figure often mentioned was £25million GBP)
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Assistance is at hand to encourage SMEs to develop advanced therapy medicinal products, including those which are combinations with medical devices or active implantables.
The European Commission has just published a Regulation which sets out a service being offered by the Committee for Advanced Therapies (CAT) within the European Medicines Agency (EMEA), for micro-, small- and medium-sized enterprises.
The service comes into being on August 14, the 20th day following the publication of the Regulation in the Official Journal of the European Union on July 25, 2009, in the context of the implementation of the Advanced Therapies Medicinal Products Regulation (1394/2007/EC).
This service provides for the evaluation and certification of quality and non-clinical data for advanced therapy medicinal products in what is effectively a midway step towards obtaini ng marketing authorisation.
The certification procedure is intended to be independent from any marketing authorisation application but will facilitate the evaluation of any future application for clinical trials and marketing authorisations based on the same data.
The Regulation sets out the information and data that must be included when companies apply to use the service, and gives the CAT 90 days of acknowledging its receipt to evaluate the valid application.
The CAT will determine whether the quality data and quality testing methodology, as well as the non-clinical data and non-clinical testing methodology, comply with the relevant requirements. In some cases, a site visit may also be necessary.
Combined ATMPs/devices
Applications concerning ATMPs combined with medical devices or active implantable medical devices will, in addition to the information cited above, also have to supply evidence of conformi ty with the essential requirements of the Medical Devices Directive or the Active Implantable Medical Devices Directive, as well as the results of the assessment by a notified body.
The CAT will recognise the notified body assessment in its evaluation, although it may request the notified body to transmit any information related to the results of its assessment.
The notified body is then due to transmit the information within a month, leading to a suspension of the 90-day countdown while the information is awaited.
Where the application does not include the results of the assessment the Agency may:
- seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the CAT, advised by its experts for medical devices, decides that involvement of a notified body is not required (where the countdown is put on hold); or
- exclude from the evaluation the check of conformity of the medical device with the essential requirements. In this case, the evaluation report and any certificate provided may also conclude that the interaction and compatibility between the cells or tissues and the medical device cannot be evaluated in the absence of the results of the assessment by a notified body.
The Regulation advises that in assembling the dossier for application for certification, applicants shall take into account the scientific guidelines published by the Agency relating to the minimum quality and non-clinical data set out in the second and third subparagraphs of Article 2(1) for the certification of advanced therapy medicinal products.
Finally, the EMEA is required to include in the Annual Report of its activities a section on the experience gained as a result of the application of this Regulation.
This section shall, in particular, contain statistical information on the type and number of applications made under the Regulation.
Source: Clinica Online 29 July 2009
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7th October 2009
Cavendish Conference Centre, London
The EU Services Directive will be implemented on 28 December 2009 - creating significant new opportunities for UK businesses. Suppliers must be aware of the impact the Directive will have on their business.
The EU Services Directive aims to break down barriers to cross-border trade in services between countries in the EU. It will make it easier for service providers, particularly small and medium-sized enterprises (SMEs), to offer their services to customers in other EU countries, whether by establishing elsewhere in the EU or by providing services remotely from the UK.
The Directive aims to break down these barriers by:
- Abolishing restrictive legislation and practices that hinder service providers from setting up in or providing services within the EU
- Setting up Points of Single Contact in each Member State through which providers will be able to find the information and complete the formalities necessary for doing business in the Member State in question
- Facilitating greater co-operation between regulatory and authorisation bodies across the EU, thereby reducing burdens on business
- Engendering consumer confidence in cross-border service provision through access to information and the high quality of services
The EU Services Directive will stimulate economic growth both in the UK and across the EU. Attend this conference to hear from the leading experts in its implementation on the opportunities the Directive could provide for your business.
http://www.bipsolutions.com/
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