RoHS Regulations: Government Guidance Notes

Explanatory guidance is now available to assist those placing electrical and electronic equipment on the UK market to comply with The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008, as amended by The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) Regulations 2009 (the RoHS Regulations).

For a copy of the guidance, published 30 June 2009, please go to -

http://www.berr.gov.uk/files/file52010.pdf

Clinical Investigation Agreement Published

The Contract Research Organisations (CRO) version of the model Clinical Investigation Agreement for medical technology research conducted in NHS hospitals was published on 26/6/09.

It can be found through the following links:

http://www.nihr.ac.uk/Pages/default.aspx
http://www.abhi.org.uk/technical_regulatory/groups/clin_invest.aspx
http://www.ukcrc.org/regulationgovernance/modelagreements/cromcia.aspx

The Agreement is intended to be used in unmodified format to enable the faster set up of commercial Clinical Investigations which are outsourced to CROs, as one of a number of bureaucracy-busting measures to improve the NHS c linical research environment for industry. Versions for use in the Devolved Administrations have been produced.

MHRA Updated Guidance on Clinical Investigations

The UK's Medicines and Healthcare products Regulatory Agency has introduced updated guidelines for conducting clinical studies of medical technologies. The 45-page revised guidance reflects changes made by the EU in regulatory requirements for clinical data under its updated medical device directives.

For a copy, please follow this link:

http://www.mhra.gov.uk/

EC Addresses Possible Overlap With Machinery Directive

Addressing devicemakers’ fears of potential conflicts in trying to comply with the EU’s Machinery Directive and its Medical Devices Directives (MDD), the European Commission (EC) has modified the MDD to eliminate that possibility in the long term.

However, devicemakers may find themselves subject to the Machinery Directive for a few months as it becomes applicable December 29th, and the revised MDD will not be applied until March 21, 2010.  In a clarification posted on its website last month, the EC offers some advice to help manufacturers prepare for the MDD. Please follow this link for more information:

http://www.fdanews.com/ext/files/IMDRM_files/2007-47-EC-guidance-final.pdf

European Commission Streamlines Standards Process

The European Commission has developed a new database for managing standards, including those it has mandated and harmonised under the medical device directives.

The purpose of the database, known as HAS, is to accelerate and facilitate the publication of the references of harmonised standards in the Official Journal of the European Union.

The database which was developed in co-operation with CEN, the European Standardisation Committee and CENELEC, the European Committee for Electrotechnical Standardisation is already fully operational.  The database is not open to the public.

Source: Clinica Magazine 1345 Jul

European Commission Publishes Two Updated Borderline Medical Device Guidance Documents

MEDDEV 2. 1/3 rev 3
Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative

The EU regulates device and pharmaceuticals products as either medical devices or medicinal substances and does not have a "combination" category, but the EU does address the regulation of medical devices which incorporate a medicinal substance(s).

Correct and consistent delineation between the EU regulatory paths for medical devices (Medical Device Directive 93/42/EEC - MDD and the Active Implantable Medical Device Directive 90/385/EEC - AIMDD) and medicinal products (Medicinal Products Directive 2001/83/EC5 - MPD) is critical for timely market clearance in the EU.

The MEDDEV 2.1/3 Guidance published by the European Commission (EC) provid es explanations, examples and illustrative guidance to be used as a tool for supporting correct and consistent interpretation of European regulatory paths and submission requirements.

This guidance is critically important to medical device manufacturers needing CE Marking of "combination" medical devices that incorporate a medicinal substance or a human blood derivative. The guidance reflects current EC thinking and is the basis for Notified Body consultations with European Union (EU) medicines authorities and the European Medicines Agency (EMEA).

The guidance has been updated to incorporate changes introduced by the 2007/47/EC amendment to the MDD and the AIMDD. Manufacturers of "combination" devices are strongly encouraged to obtain and familiarize themselves with the new guidance below.

This essential guidance document was updated in July 2009 on the EU website:

http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_2_1_3_rev_3_072009.pdf
  
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

In May 2009, the EC also updated this important guidance tool. This guidance gives valuable insight and guidance on the EC, Member State and Medical Device Expert Group's (MEDG) regulatory viewpoint and suggested interpretation on borderline products that may be considered in the gray zone of the regulation and options for placing on the EU Market:

Visit the EU Website to download:

http://ec.europa.eu/enterprise/medical_devices/wg_minutes_member_lists/version1_4_manual072009.pdf

Australia Highlights Differences in EU, TGA Regulations

Devicemakers who wish to manufacture for both the European and Australian markets must make sure they use Global Medical Device Nomenclature (GMDN) system codes appropriately and account for other differences in the regions’ regulatory requirements. While the two areas share many similarities in their regulatory frameworks, they have different rules for the GMDN system, in vitro diagnostic devices and the sponsorship of devices, according to a guidance posted on Australia’s Therapeutic Goods Administration’s (TGA) website last month.

Source: Device Daily Bulletin

Japan Takes Steps to Speed Launch of New Devices

Device manufacturers should be able to introduce products to the Japanese market faster once the country expands its device review staff and improves good clinical practices for devices. The country also plans to promote the rationalization and simplification of clinical trials and approval reviews while securing the safety of devices, Japan's Ministry of Health, Labour and Welfare says in a report recently posted on the agency's website.

Source: Device Daily Bulletin

Starting Device Trials in China May Be Time Consuming

Devicemakers planning to begin a clinical trial in China should expect the process to take an average of nine to 11 months, including the two months needed for translation and other preparation of the trial application. But the rapid patient recruitment typical of China can make up for the lengthy start-up period.  Jenny Zhang, director of business development for Tigermed Consulting, said at a recent conference.

Conducting device trials in China can be simpler than drug trials with regard to good clinical practice and ethics committee approval. Zhang advised sponsors to plan ahead, communicate properly, conduct tailored training programs, and assemble a strong local operation team or partner and sufficient monitoring resources.

Source: Device Daily Bulletin

Researchers Publish Comprehensive Model For Medical Device Development

In an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, researchers at Stanford University have published the first comprehensive model representing the medical device development process.

Published in the June 2009 issue of the Journal of Medical Devices, the model was constructed based on best-practice analysis and interviews with more than 85 seasoned experts actively involved in the development, commercialization, regulation, and use of medical devices.

Presented in linear form with five major phases and four decision gates, the model describes a process that is applicable to a broad range of medical technologies and innovation settings. According to the authors, the model is used by the developers of both highly sophisticated premarket ap proval (PMA) and premarket notification (510(k)) devices, for which FDA approval typically requires some risk-appropriate form of bench or clinical data, as well as by the makers of less sophisticated devices that may be exempt from most regulatory requirements. The five major phases and decision gates include:

• Phase 1/Gate 1: Initiation, opportunity, and risk analysis.
• Phase 2/Gate 2: Formulation, concept, and feasibility.
• Phase 3/Gate 3: Design, development, verification, and validation.
• Phase 4/Gate 4: Final validation and product launch preparation.
• Phase 5: Product launch and post-launch assessment.

The study results demonstrate that a significant portion of the development process is governed by regulations that influence the manner in which medical devices are developed, approved, and brought to market. The pace at which such regulatory requirements can be met determines when the device will reach the clinic.

Among the key results of the study is a detailed explanation of the significant differences between medical devices and pharmaceuticals, and the corresponding differences in their development processes and regulatory requirements. Such variations have dramatic downstream effects that distinguish the capital requirements, product development methods, clinical testing requirements, manufacturing methods, and overall life cycle for products in the two sectors.

The article emerged from research performed by the authors as part of a study, “Medical Device Development Models,” funded by the Institute for Health Technology Studies (InHealth). A review of the background, mission, and statutory requirements for medical device regulation in the United States was published by the authors in the December 2007 issue of the Journal of Medical Devices.

Source: ScienceDaily.com