Archive for the ‘Regulation’ Category

Proposed Amendments to Medical Device Regulations Stress Balancing Patient Safety with Innovation

Friday, August 2nd, 2013

Following the decision in early July by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) to delay its vote on the medical device regulations, the Committee on the Internal Market and Consumer Protection published an opinion report making amendment suggestions.

Russian Government May Exclude Foreign Manufacturers from Certain Medical Device Tenders

Thursday, August 1st, 2013

Medical device companies may find it more difficult to export products to Russia in the near future, according to the German foreign trade agency Germany Trade & Invest (GTAI). The Russian Ministry of Industry and Trade reportedly is preparing a law that would prohibit foreign companies from participating in government ...

What’s the Fuzz? US FDA Gets Serious about Cyber Security

Sunday, July 28th, 2013

Nightmare scenarios of hackers targeting medical devices has been getting a lot of buzz lately. Last year, IT security researcher Barnaby Jack from McAfee showed how an insulin pump could be hacked into and, potentially, cause fatalities. Jack was found dead earlier this week (the cause of his death is ...

Russian Authorities Extend Registration Deadline for Medical Devices

Thursday, July 18th, 2013

According to a report from Reglink, medical device companies selling their products in Russia now have three more years to re-register their devices. On 1 January 2013, the government announced that manufacturers would have to list their products in a new registry maintained by central regulation agency Roszdravnadzor by 1 January ...

ENVI Committee Delays Vote on Medical Device and IVD Regulations

Tuesday, July 9th, 2013

The Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament has postponed its vote on the new medical device and IVD regulations until September, reportedly because the members of the European Parliament (MEPs) are not able to come to an agreement on what the final ...

Medtech Agreement Could Be Relatively Easy Win in EU-US Free Trade Talks

Monday, July 8th, 2013

A single globally-recognised approval process for medical devices has long been at the top of the medtech industry's wish list. No one expects a fully harmonised system to materialise any time in the foreseeable future, but the Transatlantic Trade and Investment Partnership (TTIP) negotiations, which began today, may represent the ...

Premarket Authorisation System Would Destroy EU Medtech Industry’s Competitive Advantage

Sunday, June 30th, 2013

Circle 10 July 2013 on your calendar. That is when a European Parliament committee will vote on a report calling for a new premarket authorisation (PMA) system for implantable devices, including randomised clinical trials. The stakes are enormous, according to Eucomed chairman Guy Lebeau, who told Reuters that overreach in ...

UK Royal Academy of Engineering Report Outlines Lessons Medtech Industry Can Learn from Engineering Sector

Wednesday, June 19th, 2013

The medical device industry has much to learn from the engineering sector when it comes to demonstrating the safety of new devices, according to a report from the UK Royal Academy of Engineering.

UK MHRA Announces Tracking System for Medical Implants

Friday, June 14th, 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is piloting a new tracking system for high-risk medical devices. The tracking system will start in four NHS trusts and will incorporate unique device identifiers (UDIs) into patient electronic records and national Hospital Episode Statistics databases, and analysis by the Clinical ...

Eucomed Publishes Guidance on RoHS 2 for Medical Device Manufacturers

Friday, June 7th, 2013

The Eucomed Electronic Devices Working Group has published a guidance document to clarify conformity assessment requirements for manufacturers of medical devices that fall within the scope of the recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU (RoHS 2). Like the medical device directives, RoHS ...

France Implements Remaining Sunshine Regulations for Healthcare Professionals

Friday, May 31st, 2013

If you are active in the healthcare sector in France and provide "benefits" to healthcare professionals or other industry stakeholders equal to or greater than €10, you will be obligated to make that information public. French decree 2013-414, which was published in the Official Journal on 22 May 2013, will ...

More Noncompliant Implants Marketed by Ceraver

Wednesday, May 29th, 2013

Le Parisien newspaper reported this week that Ceraver, which made news earlier this month when it was revealed that it sold improperly certified hip implants to hospitals, has also marketed noncompliant knee implants. According to the daily, which also broke the hip implant story, some 50 patients are walking around ...