Julie Moore
We are super excited to offer Evnia UKRP and be part of the regulatory journey for manufacturers bringing their medical devices to the UK market.
The UKRP addition to Evnia representation services allows us to offer both EUAR and UKRP to manufacturers with one single point of contact and streamlined conformity verification review process. With the development of the UK medical device regulations well underway and the insights taken from the MHRA consultation responses, we anticipate that the UKRP will become similar in its role, responsibility and liability as the Authorised Representative in Europe, and for this reason we wanted to offer a single trusted partner with experience in both EU and UK regulatory environments to support with market access in these countries. Evnia UKRP has specialists able to assist with UK requirements and regulatory developments in the UK as the new regulations are implemented, therefore whether its UKRP representation, UKCA marking support or UK regulatory strategic guidance in general, Evnia UKRP team can assist.
Dr. Efstathios Vassiliadis
We are excited to add our UK Responsible Person (UKRP) arm to be able to support the manufacturers in UK, in the post Brexit regulatory environment. Evnia’s commitment to the highest standards of compliance applies to all the manufacturers we work with, and we are proud to contribute to this journey of quality and excellence, with patient safety at the center of our activities.
We are here to assist
Need more details?
Phone Number
020 3386 9549
Email Address
info@evnia-ar.com
Website
https://www.evnia-ukrp.co.uk
Address
1 Canada Square, 37th Floor, London, E145AA
