Archive for the ‘Regulation’ Category
Wednesday, May 15th, 2013
Last month, we reported on progress in setting the foundations of a harmonised unique device identification (UDI) system. US FDA seems to be on track to present its final draft of a UDI system to the International Medical Device Regulators Forum (IMDRF) in November 2013, and a consensus has formed ...
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Wednesday, May 8th, 2013
Citing the relatively limited amount of clinical evidence needed to CE mark a medical device and lessons learned from the Pip breast implant scandal, Bruce Campbell and colleagues from the National Institute for Health and Care Excellence (NICE) are calling for a more robust regulatory environment in the current issue ...
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Sunday, March 24th, 2013
Guest blog from Warren Ward-Stacey, Prisym ID:
[caption id="attachment_30582" align="alignleft" width="175"] Warren Ward-Stacey[/caption]
For medical device manufacturers, ensuring accurate and consistent product labelling remains a challenge. From compliance demands for a design-to-print audit log to the complex mix of variable bar codes, images and text required on each label, the process is ...
Posted in medtechinsider, Regulation | 1 Comment »
Wednesday, March 13th, 2013
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched an innovation office to help companies that are developing innovative healthcare products navigate the complex landscape of regulatory approval. The goal of the office is to promote dialogue between companies and the UK MRHA, particularly on when specific UK ...
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Tuesday, February 19th, 2013
What are you doing on 26 February? If you have an interest in the proposed medical device regulation and how it will affect patient safety and time to market, then you should make plans to be in Brussels. The European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee has ...
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Wednesday, January 30th, 2013
In its current newsletter, the German Medical Technology Association BVMed reports that the German political parties CDU/CSU and FDP are in favour of stricter medical devices regulations. The parliamentary groups of the CDU/CSU and FDP are urgently calling for stricter European regulations for medical devices. In a parliamentary motion the ...
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Thursday, January 17th, 2013
The German Medical Technology Association BVMed is asking the European Commission, the Council and the Parliament to take immediate action on appropriate measures to improve the designation and surveillance of notified bodies and market surveillance of medical devices. "Legal measures should be implemented early, preferably this year, to re-establish confidence ...
Posted in medtechinsider, Regulation, Trade Associations | 1 Comment »
Monday, December 17th, 2012
The European Parliament approved a unitary patent package that could cut costs of an EU patent by up to 80%, according to a press release on the Parliament's website.
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Thursday, December 13th, 2012
As 2013 approaches, why not plan to make some New Year's resolutions for your business, like a commitment to kick of 2013 by preparing for new medtech regulations and standards? The regulations and standards landscape in Europe for medical device manufacturers will change dramatically in the next few years. This ...
Posted in Regulation | 1 Comment »
Wednesday, December 5th, 2012
A ruling by the EU Court of Justice last month might make it less clear what the difference is between the definition of medical devices and devices for general health, according to life science and IP lawyer Erik Vollebregt, who blogs about medtech matters on medicaldeviceslegal.com.
Posted in Regulation | 3 Comments »
Tuesday, November 20th, 2012
A surprising number of UK National of Health Service providers are either unfamiliar with or unprepared for implementing the actions outlined in the UK government's plan to spread innovation, a recent report found. The report was published last week by policy consultancy firm MHP Health Mandate and funded by Sanofi. ...
Posted in Regulation | 1 Comment »
Monday, November 19th, 2012
On 14 November, which was the World Diabetes Day, US FDA released official final draft guidance for an artificial pancreas. Several companies, including Medtronic, are in a race to develop the first artificial pancreas and the draft guidance is an important milestone.
Changes in government reimbursement policies are causing a rapid ...
Posted in Business News, Diagnostics, Regulation | Add Comment »
