What is the Medical Device Regulation?
The Medical Device Regulation (MDR) is a new regulation that will replace the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC when it is published, currently estimated for Q4 2016.
Why is the MDR necessary?
Since the MDD and AIMD was first published in 1993 and 1990 respectively, constant scientific and technological progress, substantial deviations in the interpretation and application of the rules, and the perceived lack of transparency have all led to the existing directives coming under criticism in recent years.
The new regulation aims to overcome the perceived flaws and divergences and further strengthen patient safety via a robust, transparent and sustainable regulatory framework that is ‘fit for purpose’.
What does the regulation cover?
The MDR applies to all medical device manufacturers who intend to place or distribute their products within the European Economic Area.
It covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in the In Vitro Diagnostic Device Regulation (IVDR).
LRQA as a Notified Body
LRQA has been a leading Notified Body for over 20 years, and is independently accredited by the relevant accreditation bodies to provide CE marking to both existing directives - Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC.
We are currently working towards having a full scope as a Notified Body under the new MDR.
We can perform product conformity assessment and certification activities against the existing MDD 93/42/EEC:
- Design dossier - conducting design dossier examinations for Class III devices
- Verification - verifying that your technical documentation meets the requirements of the directive and is implemented within the system
- Continued surveillance
Why choose LRQA?
Get it right the first time, on time
To win in the highly regulated and high stakes world of medical devices manufacturing, it is crucial to beat the competition to the market, and minimise any potential losses from surprise product launch delays.
Our thorough yet streamlined approach ensures you get the right type of guidance at any stage of the product lifecycle, towards a timely market launch.
As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA is actively shaping the medical directives and associated harmonised standards through our experts’ participation in the MDD and IVDD technical committees and associations, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).
LRQA helps to unlock the power of your management systems to improve organisational performance and reduce risk. We also provide input to regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.
To find out more about how LRQA can help you with your requirements, email us at firstname.lastname@example.org.