Compliance & Regulations
It isn’t as simple as manufacturing and then marketing a medical device in the EU as there are plenty of compliance regulations.
There is a multitude of requirements and which ones apply, depend on the intended use of the device, function, manufacture and others.
There are also a multitude of organisations that have an interest in the public’s health and
safety
including the NHS, CCGs, PHE, DHSC, CQC, HSE, FSA and many others.
CLASS I
The LifeVac ACD is a CLASS I medical device as described in Part II of the UK MDR 2002, Annex IX (as modified by Part II of Schedule 2A to the UK MDR 2002).
EU MDD & UK MDR
2002
EU MDDs or Medical Device Directives are/were designed to harmonise the laws across the EU in relation to medical devices. LifeVac remains compliant with EU MDD and the accompanying EU Directives and Regulations.
UK MDRs or Medical
Device Regulations are specific to the UK and draw from the EU MDD. With the UK
leaving the EU changes to the UK MDR are planned. LifeVac remains compliant with the UK MDR and the
accompanying UK Directives and Regulations.
MEDDEV
The official guidance
for Medical Devices are known as MEDical DEVice documents.
This guidance covers a wide range of topics including;
Clinical assessment, rationale and evaluation, Safety and Post Market surveillance, Requirements of
conformity to relevant standards and legislation.
MEDDEVs are used by manufacturers, Notified Bodies, Competent Authorities and regulators such as the MHRA to ensure the safe and regulated introduction of medical devices.
Not all MEDDEVs are applicable to a device or device type. It is between the manufacturer and the regulator to agree which MEDDEVs are applicable prior to deployment of any device into a market.
LifeVac has worked with the MHRA to agree on which MEDDEVs were applicable.
Once these had been completed, they were subsequently agreed with the regulator.
Some of the principle
considerations have been outlined here, with a particular focus on those that
are queried most often.