Archive for the ‘EU Regulatory’ 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.

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 ...

New Commissioner for Consumer Policy Wants to Maintain EU Medtech Industry’s Competitive Edge

Thursday, June 20th, 2013

Last week the European Parliament approved Croatian candidate Neven Mimica as Commissioner for Consumer Policy. In this position, Mimica is responsible for the medical products sector. Mimica will be the first Commissioner from Croatia. The country joins the European Union on 1 July 2013 and, like every EU member state, ...

France Lets “Sunshine” In: What Transparency Really Means for the Medical Industry

Tuesday, June 11th, 2013

As reported in medtechinsider on 31 May 2013, France has implemented the remaining sunshine regulations. The regulations are an extension of the Bertrand law, which was passed in 2011, requiring all healthcare-related enterprises to exercise greater transparency in their relations with customers. In this article, René Clément, co-chair of Medimark ...

Medical Device Regulations Draft: MEPs Propose more than 900 Amendments

Monday, June 10th, 2013

The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments ...

The Tangled Destinies of Europe’s UDI, Eudamed Database and Medical Device Regulation

Monday, June 10th, 2013

From the Consultant’s Corner Newsletter, June 2013 The European Commission published its recommendation for a common framework for a unique device identification (UDI) system for medical devices in April 2013. The announced primary objective of recommendation 2013/172/EU is to improve patient safety by facilitating vigilance, market surveillance and transparency through heightened ...

Pert UDI Seeks Compatible Database for Harmonised Relationship

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 ...

Progress Being Made in Europe’s Unique Device Identification System

Sunday, April 14th, 2013

While there is much uncertainty regarding the details of a unique device identification (UDI) system that is in the works in the United States and Europe, progress is being made. The International Medical Device Regulators Forum (IMDRF), which picks up where the defunct Global Harmonization Task Force left off, announced ...

And Then There Were Eight: the 2013 Revision of EU Vigilance Guidelines for Medical Devices

Thursday, March 14th, 2013

From the Consultant’s Corner Newsletter, March/April 2013 Revision 8 of MEDDEV 2.12-1, the new European medical device vigilance guidelines, will replace the current version in July 2013. Are you ready? The time is right to ask the question, since you may need to update your vigilance procedure.

Medtech Stakeholders at ENVI Meeting Back New Device Regulation, with Some Reservations

Thursday, February 28th, 2013

Yes, Europe's regulatory system for medical devices is in need of an overhaul to improve patient safety and maintain timely access to innovative medical technology. No, the scrutiny procedure is not the best way to achieve that goal. That was—almost—the consensus at a meeting organised by the European Parliament’s Environment, ...

Device Regulation’s Implant Card Measure Will Contribute to Patient Confusion, Not Safety

Wednesday, February 20th, 2013

Much ink has been spilled over the scrutiny procedure in the proposed medical device regulation, but relatively little has been said about article 16, which would require an "implant card" to be distributed with each implantable device and provided to the patient who has been implanted with the device. Rolande Hall, ...

Dump Scrutiny Procedure, Ratchet Up Oversight of Notified Bodies in Medical Device Regulations, Says Eucomed

Thursday, January 31st, 2013

As promised by MedTech Europe CEO Serge Bernasconi in his baptismal blog post earlier this week, Eucomed has published its formal response to the new EU medical device regulations that are before the European Parliament. While Eucomed and industry favour many of the proposed measures, the scrutiny procedure has been a significant ...