MHRA Registration – Ensuring you are up to date!

Registration with the Medicines & Healthcare products Regulatory Agency (MHRA) is a legal requirement as all dental laboratories are required to comply with the Medical Devices Directive and Medical Devices Regulations.

Have you moved address?

Have you changed your trading name?

If the answer is yes then you need to inform the MHRA by completing an RG2 form  – www.mhra.gov.uk

It is also advisable that you check that you are listed on the MHRA register as many laboratories details have been archived following the 2008 live publishing of the register. Visit – http://aic.mhra.gov.uk/era/pdr.nsf/devicecode?openpage&RestrictToCategory=K1&start=1&count=200

Raising the profile of dental laboratories – fighting off the competition

With competition ever more fierce throughout the dental field, many more laboratories are taking up the DAMAS Scheme as an effective marketing tool. DAMAS helps to prove to clients, old and new, just how hard laboratories work to produce compliant, high quality appliances.

The number of laboratories currently registered in the North of England alone is fast approaching 120.

Closing nonconformities – completing the paperwork

For each nonconformity you receive during a DAMAS audit you will need to implement corrective actions to address the issues and complete a nonconformity finding report for the auditor detailing your actions.

If you are struggling to complete your nonconformity finding report then below is an explanation of how to compete your corrective action plan (detailed on the forms as section 3).

Root Cause – complete this section by detailing what the problem was and what caused the issue to happen in the first place.

Correction – complete this section detailing how you corrected the problem

Corrective action plan – complete this section detailing what plans you will or have put in place to stop the problem reoccurring.

Plan for verification of effectiveness – complete this section by detailing how you are going to check/verify that your corrective action plan has worked or been effective.

Remember – you will not receive your DAMAS certificate until your auditor has received your completed report.

Registrations hit an all-time high this month with 296 dental laboratories now being DAMAS registered.

So what does this equate to nationally?

Congratulations go to the following dental laboratories that have been re-inspected against the DAMAS Specification during September 2013:

Congratulations go to the following dental laboratories that achieved DAMAS registration during September 2013:

Wimbourne Dental Laboratory Ltd, Bournemouth

Kerakraft Dental Laboratory, Penzance

DK1 Dental Laboratory, St Helens

JA & A Hunter Dental Laboratory, Northumberland

Medenta Laboratories Ltd, Norwich