Kavita :
I presume that you have heard that the current EU regulatory framework for medical devices (based on the AIMDD, MDD, and IVDD) is in the process of being replaced with two new regulations : the Medical Devices Regulation [MDR, (EU) 2017-745] and the In Vitro Diagnostic Medical Devices Regulation [IVDR, (EU) 2017-746].
These are sweeping changes, to be honest, and as I read elsewhere "if you start preparing now, you're already too late". More emphasis on clinical evidence (pre- and postmarket), better defined responsibilities for the so called "economic operators", UDI, updates to the Essential Requirements (are renamed : General Safety and Performance Requirements), to mention a few of the changes.
In this RAPS Forum we will definitely see issues relating to these two Regulations coming up, especially during the transition times for these Regulations. May I suggest that you start by having a look at the text(s) of the Regulation(s) that is (are) of interest to you ? And there is already a wide variety of (free) white papers and (free and for fee) webinars out there to help you getting started. So get hold of a few of those (if you want to, I can send a few of them to you via e-mail). See if you can attend a one or two day training event. Maybe a knowledgeable consultant can be of use to guide you through the transition.
Expect more publications to follow : the so called Delegating and Implementing Acts mentioned in the Regulations, updates to the MEDDEV guidance documents, and more white papers, blogs, etc.
Be mindful of which current Notified Bodies will be re-notified under the new Régulations, the scope of their re-notification, and when they will first be able to deliver certificates under the new regulations.
And be mindful that there is no "grandfathering" of existing devices : devices that are in compliance with the current Directives must be brought in compliance with the new Regulations or you must cease distributing them on the European market.
In short : too much to address in a short post like this. Nevertheless, hope this helps and with kindest regards,
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Ary Saaman
Director, Regulatory Affairs
Debiotech S.A.
Lausanne
Switzerland
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Original Message:
Sent: 29-Oct-2017 18:58
From: Kavita Sharma
Subject: What changes are occurring to the European Medical Device regualtions
Hi
Could we discuss what changes are occurring or have occurred to the MD EU regulations?
thank you
Kavita