Regulatory and Quality News
See below for recent articles of related to medical device certification and testing regulations. For in-depth articles relating to such issues, be sure to check out LNE/G-MED's Progress Report newsletter archives.
November 9, 2011
The key changes to IEC 60601-1 3rd Edition
Starting for many in June 2012, electro-medical device manufacturers must conform to a new safety and performance standard. For many manufacturers, this may translate into increased design costs and timelines and already causes confusion as many of the complimentary standards are not yet complete. LNE/G-MED examines IEC 60601-1 3rd ed. and can help the manufacturer understand the changes so the manufacturer can make the best decision to ensure the products stay on the market. LNE’s expertise on 60601-1 3rd ed. is extensive. As a leader among Notified Bodies, LNE/G-MED will be able to give manufacturers its official position on the practical issues in the implementation of the 3rd ed. at the end of November, confirming its role.
The key changes to 60601-1 3rd ed. revolve around the new link between performance and safety, where there was no link in previous editions. The definition of “safety” in the new edition includes not only safety measures but also “essential performance” matters. The standard gives the example of monitoring equipment, where the medical device’s essential performance (correctly measuring and reporting the patient’s vital statistics) has a direct correlation to its safety. Indeed, a medical device that reports a patient’s vital statistics incorrectly could gravely endanger a patient’s life. Additionally, this concept of safety not only includes the patient’s safety, but the operator’s safety and usability of the product. Medical devices now must not only safely operate, but must also be safely operated in order to pass the requirements in IEC 60601-1 3rd ed.
In addition to these new definitions, the revisions apply the risk management requirements of ISO 14971 to the design process. For manufacturers, this means a much greater up-front investment in a device in order to ensure it complies with the standards in the stage of development and not only in operation. Manufacturers must start compliance with the standards much farther upstream than they had previously. Additionally, the new edition applies to both new and existing devices, which means some manufacturers may need to start over from scratch for some devices. For more on the changes in IEC 60601-1 3rd ed. and how LNE/G-MED can guide you through the changes you need to make, contact us.
June 16, 2011
EC Releases “Electronic Instructions for Use” Draft Document
Providing medical device instructions in electronic form, rather than paper, can be seen as an environmentally friendly way to cut costs, while maintaining or improving safety. The European Commission just released the long-awaited draft of its “ Electronic Instructions for Use of Medical Devices.“ While these rules do not apply to IVDD, a MEDDEV guidance document addresses the IVDD sector.
The Regulatory Committee on Medical Devices is expected to deliberate on the draft Regulation in September 2011. Details when available will be published in Progress Report Newsletter. Sign up here.
March 28, 2011
Termination of GHTF Draws Industry Concern
The Global Harmonization Task Force (GHTF) will be replaced with a regulators-only forum. For the past 18 years, the GHTF has been committed to facilitating greater uniformity among national and regional medical device regulatory systems. The decision, taken at a recent meeting of regulators from the five GHTF founding member regions: U.S., EU, Japan, Canada, and Australia, drew disappointment from a variety of medical industry associations currently represented on the task force.
Here is the Statement from GHTF.
Here is the Joint Statement from AdvaMed, EucoMed, and Medical Technology Association of Australia (MTAA)
February 23, 2011
EC Recast of IVD Directive 98/79/EC
Last year, the European Commission launched a "public consultation" on issues related to the In Vitro Diagnostic Directive (IVDD), as reported in LNE/G-MED's Progress Report).
The EC received 183 responses, including a joint response from LNE/G-MED and other notified bodies. Access the full document at: IVD Directive 98/79/EC Public Consultation Responses.
December 9, 2010
European Commission: 2 new MEDDEVs on Clinical Investigation
The European Commission released 2 new MEDDEV relating to Clinical Investigation. One highlight is that "Discussion with a competent authority or a notified body may be appropriate when there is uncertainty as to whether the proposed clinical investigation plan is sufficient." - MEDDEV 2.7/3 Clinical investigations: serious adverse event reporting + SAE reporting form (December 2010)
- MEDDEV 2.7/4 - Guidelines on Clinical investigations: a guide for manufacturers and notified bodies (December 2010)
For links to all MEDDEVs, see the European Commission Web site.
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