Medical Device QA/RA Outsourcing Services
Now that the UK has left the EU, all medical device and IVD manufacturers based in the UK MUST designate an Authorised European Representative (EC REP) who is based in a full member state.
Via our partners based in Cork, Ireland, we will ensure a smooth initial registration or transfer over to the Irish Competent Authority (HPRA).
Several new AER companies have ‘sprouted up’ since this new requirement came about due to ‘Brexit’ and is now law (according to the new MDR and IVDR Regulations). Do they have a solid track record of assisting their clients? We do, and we can provide references upon request who will attest to our professionalism.
We have been an AER for over seventeen (17) years and offer the following support as part of our service:
– Dual registration within the UK and Ireland for full EU compliance
– One fee (not two) to cover both the UK and Irish support services
– Significantly reduced costs due to registering ‘en-block’ with our other clients
– Assistance with device labelling/artwork
– Regulatory guidance should your device be involved in an Adverse Event (AE)
– Guidance on the transition from the MDD / IVDD to the MDR / IVDR Regulations.
– Assistance to find an alternative Notified Body, should your UK Notified Body be unable to support their ISO 13485:2016 / CE Marking certification.
Almost mirroring the services outlined above, post-Brexit, it is now required for manufacturers outside the UK to have a UK Responsible Person (UKRP) mandated. This is also a service that we provide regularly.