Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 31 July 2013
A new opinion report just published by the European Parliament's Committee on the Internal Market and Consumer Protection on the Committee on the Environment, Public Health and Food Safety's (ENVI) medical device and IVD proposals calls for changes to be made, citing the proposals' potential to be overly restrictive to the "free movement of products."
In April 2013, ENVI made an unprecedented proposal to require many medical devices to undergo a premarket authorization procedure similar in concept to one established by the US Food and Drug Administration. Currently, such medical products undergo a largely decentralized regulatory process in which individual states primarily oversee products, and companies' adherence to regulations is checked by organizations known as notified bodies.
That system, however, has been under fire as of late. Thanks to several high-profile safety scandals-defective breast implants, faulty hip replacements and dangerous vaginal mesh implants among others-legislators have begun to study whether devices marketed in the EU were being adequately regulated, and if not, how to best do so.
That process has largely fallen to ENVI Rapporteur Dagmar Roth-Behrendt, an influential member of the European Parliament from Germany who released draft legislation in April 2013. [Editor's Note: Read our analysis of her legislation here.]
But Roth-Behrendt's report has received fierce pushback from the medical device industry, which has launched a campaign to table the measure, claiming it would rob EU patients of their early access to cutting-edge medical therapies.
However, a new report from one of the European Parliament's own committees is reinforcing the ENVI proposal even as it calls for changes to be made to ensure "the benefits of our internal market."
The report from the Committee on the Internal Market and Consumer Protection lists a plethora of recommendations meant to increase its consistency, decrease the potential for over-reach, and better regulate certain types of devices.
For example, changes would restrict EMA's regulation of nanomaterials only to medicinal products. The existing regulation would have permitted any nanomaterial that interacted with the body to be regulated by EMA. Another proposed change calls for compatibility testing when two or more separate parts are implanted into the human body and are intended to work with one another.
Other proposed changes include:
The entire 82-page report is available on the European Parliament's website.
Committee on the Internal Market and Consumer Protection: Opinion Report
Tags: ENVI, European Parliament, Report, EU, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.