Drug Development Consultant & Regulatory Consultant » Medical Devices

Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

admin — Sun, 23 Oct 2011 15:39:55 +0000

Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

Full Text Here

Health Canada is in the process of creating a Medical Devices Inspection Cycle. Our goal is to make this inspection cycle risk-based. This document provides potential options in inspecting scheduling and cycles.
We are exploring changes and we would appreciate your input on key concepts that we are considering. Specially, we welcome input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk.
The following suggestions may help you prepare your comments:

Please explain your views as clearly and concisely as possible.
Be sure to distinguish between what you support and what you object to in this document.
Provide rationale for your views, particularly your concerns, with facts, data or specific examples.
Describe any assumptions that you made.

Please submit your comments by November 16, 2011.
In order to provide your comments you must submit them by sending the Word or PDF format and email them to the mdcu-ucim@hc-sc.gc.ca.
Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of this review. The summary report will be made available to stakeholders once consultations are complete.

For Assistance with Medical Device Regulation Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

Fill Out the Short Form Below…

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Advancing the need for cultural localisation of medical device software tools

admin — Sun, 16 Oct 2011 12:44:09 +0000

Advancing the need for cultural localisation of medical device software tools

Article by Associate Consultant Mark Gibson

Software localisation of medical devices is not a universal regulatory requirement. However, software localisation is vital as a competitive tool to gain a foothold in foreign markets. This potential advantage is not only the case for medical device manufacturers, but also for all software applications that aim to be used outside their native language regions.

Take, for example, a medical device that incorporates a software program that relies on date expression for safe and effective use. The software originates in the USA, whose developers programmed date to be expressed as follows:

02.12.2010 (for 12^th February 2010)

The device and software in question is to be marketed in the UK, Spain, Sweden and South Korea. However, date expression differs from country to country, as is illustrated with the example of 12^th February 2010 below:

USA	UK	Spain	Sweden	South Korea
02.12.2010	12.02.2010	12/02/2010	2010-02-12	2010.02.12

However, the software, in its current iteration, cannot accommodate these cultural date conventions. From this example, it is possible to see at a glance the potential confusion this could bring to a user in each country if the original US format is not localised to the respective countries’ usual formulations of date expression. Another common example is how units of measurement are expressed, such as the UK Imperial system, the US Customary system and the more internationally recognised metric system.

Product localisation and cultural adaptation can help address safety issues related to human factors, such as the risks outlined above with the improper interpretation of date/time information or unit of measurement. Safety issues in medical device development can be identified in trials and resolved in the development process in the initial locale, i.e. where the device was created, before it goes to market. However, the impact of faulty translation and localisation issues that affect safety are not as carefully controlled, verified or validated and many such issues are not identified until after the product has been licensed and marketed. This can often lead to product recalls in the countries in question, which naturally has a direct and negative impact on the manufacturer’s revenues.

Issues also worth considering are

Software localisation and cultural adaptation

Customising software application for use in different target locales will help users in different countries gain maximum benefit from your device. Typically, this would include the translation of accompanying documentation, help files, user interface components, such as screen/display text, buttons, error messages, and so on, as well as ensuring the adaptation of software to the target locale to specific local conventions and requirements, such as date/time formats. The adaptation aspect of the service would involve aspects of user-centred design or human factor testing.

Software verification and validation

The objectives of software verification and validation is to provide evidence that the design outputs of a particular phase in the software development life-cycle meets all the specified requirements for that phase, such as FDA’s General Principles of Software Validation Guidance [1]. Software validation provides insights into the usability of the tool through the provision of objective evidence from a user-centred process that the software specifications conform to user needs and intended uses of the device in question.

The business case for undertaking localisation and cultural adaptation services is supported by legislation. For instance, FDA’s Medical Device Quality System Regulation Part 820:30 (21 Code of Federal Regulations 820:30)[2] states that labelling, whether electronic, paper-based or both, is considered part of the medical device and subject to design control. In Europe, the Medical Devices Directive (MDD) [3], as well as ISO 13485:2003 also requires design control and software validation for medical devices as part of the application for Marketing Authorisation within the EU. Accordingly, as with traditional labelling, the User Interface of medical device software tool can carry vital information about the product in question for safe and effective use. For many products, the User Interface provides the medium for the user’s interaction with device. In some cases, the software is the only way to interact with the device, or with stand-alone tools, the software is the device. Furthermore, ISO14971: Medical Device Risk Management identifies a lack of product localisation as a possible cause for hazards and recommends, as standard practice, the involvement of an expert in localisation risk for both the labelling of the product and its User Interface.

In addition to the regulatory framework currently in place, the advantages of these are to:

Provide medical device developers with a tool to mitigate risk
Help to gain an advantage in foreign markets

Help to support a global user base for the product.

For Assistance with Software Localisation Click Here

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Fill Out the Short Form Below…

EMA Procedural Advice on Combination Advanced Therapy Medicinal Products (ATMPs)

admin — Tue, 31 May 2011 13:45:19 +0000

EMA Procedural Advice on Combination Advanced Therapy Medicinal Products (ATMPs)

Full Text Here
Advanced Therapy Medicinal Products (ATMPs) are medicinal products for human use, including gene therapy, somatic cell therapy and tissue engineered products.ATMPs may incorporate, as an integral part of the product, one or more medical devices, in which case they are referred to as “Combined ATMPs” as defined in Article 2 of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products .
ATMPs offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is designed to ensure the free movement of these medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical and medical technology companies in the field, while guaranteeing the highest level of health protection for patients.
All ATMPs are evaluated via the centralised procedure as defined in Article 8 of Regulation (EC) No 1394/2007, thus ensuring that they benefit from a single evaluation and authorisation procedure applicable across the EU. This makes it easier for companies to market their products and for patients in the different Member States to gain access to these products.
The Committee for Advanced Therapies (CAT) following its evaluation, drafts an opinion on the quality, safety and efficacy of each ATMP subject to marketing authorisation application (MAA). This opinion is then sent to the Committee for Medicinal Products for Human Use (CHMP), the committee responsible for human medicines at the European Medicines Agency (EMA). Based on the CAT opinion, the CHMP adopts a recommendation on the granting, variation, suspension or revocation of a marketing authorisation. The recommendation is then sent to the European Commission for a decision binding in all Member States. Such evaluation is done in line with the “Procedural Advice on the Evaluation of Advanced Therapy Medicinal Product in accordance with Article 8 of Regulation (EC) No 1394/2007” (EMEA/630043/2008) published in EMA website:

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/02/WC500070340.pdf

Regulation (EC) No 1394/2007 states that ATMPs may incorporate medical devices or active implantable medical devices as defined in Directive 93/42/EEC and 90/385/EEC respectively. In order to ensure an appropriate level of quality and safety, those devices should meet the essential requirements laid down in the relevant Directive. A Notified Body (NB) for medical devices may be or may have been involved in the assessment of the medical device part of a combined ATMP. As the CAT prepares the draft opinion on a combined ATMP, it will therefore be this Committee who primarily interacts with a NB in the context of the procedure described in this document.
Further information on various scenarios for the provision of NB assessments is provided in section 4 of this document.

For Assistance with The Regulatory Procedures for ATMPs (cell and gene therapy) Click Here

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Fill Out the Short Form Below…

EMA, The European Drug Regulatory, Publish Draft Procedural Advice on the Consultation of Notified Bodies in Accordance with Article 9 of Regulation (EC) No.1394/2007

admin — Tue, 24 Aug 2010 14:23:39 +0000

EMA, The European Drug Regulatory, Publish Draft Procedural Advice on the Consultation of Notified Bodies in Accordance with Article 9 of Regulation (EC) No.1394/2007

Full Text Here

Advanced Therapy Medicinal Products (ATMPs) are medicinal products for human use, including gene therapy, somatic cell therapy and tissue engineered products. ATMPs may incorporate, as an integral part of the product, one or more medical devices, in which case they are referred to as “Combined ATMPs” as defined in Article 2 of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products .
ATMPs offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is designed to ensure the free movement of these medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients.
All ATMPs are evaluated via the centralised procedure as defined in Article 8 of Regulation (EC) No 1394/2007, thus ensuring that they benefit from a single evaluation and authorisation procedure applicable across the EU. This makes it easier for companies to market their products and for patients in the different Member States to gain access to these products.
The Committee for Advanced Therapies (CAT) prepares a draft opinion on the quality, safety and efficacy of each ATMP subject to marketing authorisation application (MAA). This opinion is then sent to the Committee for Medicinal Products for Human Use (CHMP), the committee responsible for human medicines at the European Medicines Agency (EMA). Based on the CAT opinion, the CHMP adopts a recommendation on the granting, variation, suspension or revocation of a marketing authorisation. The recommendation is then sent to the European Commission for a decision binding in all Member States. Such evaluation is done in line with the “Procedural Advice on The Evaluation of Advanced Therapy Medicinal Product in accordance with Article 8 of Regulation (EC) No 1394/2007” (EMEA/630043/2008) published in EMA website:

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/02/WC500070340.pdf

Regulation (EC) No 1394/2007 states that ATMPs may incorporate medical devices or active implantable medical devices. In order to ensure an appropriate level of quality and safety, those devices should meet the essential requirements laid down in Annex I to Directive 93/42/EEC and Directive 90/385/EEC, respectively.
As defined in Article 9(3) of Regulation (EC) No 1394/2007, where available, results of the assessment of the medical device by a notified body (NB) for medical devices shall be included in a Marketing Authorisation Application (MAA) for a combined ATMP, and in such circumstances shall be recognised by the EMA. Further consultation of a Notified Body might be found necessary in order to ask any questions relating to the results of the previous assessment of medical device (s) (MDD(s)).
If results of a NB assessment are not available at the time of the submission of the MAA, the EMA/CAT may seek an opinion on the conformity of the device part with the essential requirements of the relevant Medical Device Directives from a suitable designated NB.
It should also be noted that any interaction between the EMA/CAT and the NB(s) will be done in conjunction with the Applicant for marketing authorisation of the combined ATMP.

For More Information on ATMPs and CAT Regultions Click Here

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Drug Regulators, MHRA, Publish Guidance on the Vigilance System for CE-marked medical devices

admin — Mon, 28 Dec 2009 09:20:31 +0000

Drug Regulators, MHRA, Publish Guidance on the Vigilance System for CE-marked medical devices.

Full Text Here

This guidance document gives advice to manufacturers on the notification of adverse incidents involving implantable neurostimulators under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of the Active Implantable Medical Devices Directive 90/385/EEC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and the MHRA’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

DeviceRegulators Publish Guidance Notice on Borderlines with Medical Devices

admin — Mon, 02 Nov 2009 16:40:53 +0000

Device Regulators MHRA publish Guidance Notice on Borderlines With Medical Devices

Full text here

Many manufacturers have difficulty in interpreting whether or not their product would be considered a medical device within the terms of the Medical Device Directive 93/42/EEC. This guidance document has been developed to aid with some of the more common areas of confusion.
It is often assumed that because a product is considered a medical device, for example in the USA or Canada, or in Japan, that it will also be a medical device within the European definitions. This is not the case and manufacturers should always refer to the definitions of a medical device when making any borderline determinations. Any such decision will be based on the stated intended purpose of the product and its mode of action. Manufacturers should also consult the available published guidance in order to determine whether or not their product is considered a medical device within the European Union. The available guidance is listed in Appendix 1 of this document.
In general, medical devices must have a ‘medical purpose’ which is determined by the definition of a medical device. They must also act primarily in a way that is not metabolic, immunological or pharmacological. Should they function in any way that is metabolic, immunological or pharmacological, in conjunction with having a medical purpose, they are likely to come within the remit of the regulations covering medicinal products instead. Further information on the borderline with medicinal products is available – see the list at the end of this document.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Grow your Expertise for Free

This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

Apple Puts Onus of FDA Clearance on iPhone Developers

admin — Mon, 29 Jun 2009 11:38:43 +0000

I have just been reading an interesting little aside on Mobihealthnews I thought I would share with you. As more and more developers are make applications (apps) for the Apple iPhone, using at as in interface for medical devices is an obvious solution and one that make allot of commercial sense. However it raises a number of issues that the FDA are currently struggling with. Any medical device needs to be approved by the FDA, and in the context of a medical device app, the iPhone becomes a medical device. However Apple have not sought FDA approval, and I would suspect are unlikely to do so, so are they in violation? its a tough call. Apple have put in a clause in their contract with application developers that the developer seeks all regulatory approvals etc, in their eyes passing the buck to the developers, however its not clear if that is acceptable to the FDA, you can’t usually contract away responsibility for medical compliance, watch this space for more on this interesting topic.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Grow your Expertise for Free

This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

MHRA guidance on the vigilance systems for medical devices- Intraocular lenses

admin — Mon, 22 Jun 2009 08:22:59 +0000

This guidance document gives advice to manufacturers on the notification of adverse incidents involving intra-ocular lenses under medical devices vigilance system. It includes, but is not limited to, the following types of intraocular lenses: posterior chamber; phakic; anterior chamber; multifocal; and accommodated. It is intended to facilitate uniform application implementation of the medical devices directive.

The kinds of things should be reported include:

Any deterioration or malfunction of an intraocular lens or any inadequacy in instructions for use which has led, on might lead to, a serious deterioration in the state of health and vision.
The intraocular lens has been subject to a field safety corrective action
Common faults that require reporting are also listed

The guidance also goes on to give some details about Periodic Summary Reporting and Adverse Incident Trending, its a short guidance but should be look at and considered by those working in the area.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Grow your Expertise for Free

This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.