MHRA Registration – Ensuring you are up to date!

We find as we visit laboratories around the country, that sometimes their details need updating with the MHRA.

Have you moved address?

Have you changed your trading name?

If the answer is yes then you need to inform the MHRA – 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It is also advisable that you check that you are listed on the MHRA register as many laboratories details have been archived following the 2008 live publishing of the register.

The MHRA now has now introduced an easier access search option on their website, making it quicker and easier for you to not only check your own status and details, but also those of other laboratories. Now rather than searching alphabetically there is also the option to type in the name or MHRA number (if known) of the company you want to check, simply by clicking on the new ‘Search Registration’ tab at the top, right hand side of the page:

http://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200

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.

Registrations hit an all-time high with 415 dental laboratories now being DAMAS registered. This rise shows a 40% increase over the past two years alone.

DAMAS Registrations in Wales and Ireland have doubled over this two-year period, as the popularity of DAMAS continues to increase countrywide.

So what does this equate to nationally?

The DLA has recently received queries regarding dental surgeries issuing their own prescriptions for appliances they wish to order from the dental laboratory. Many of the questions focus on the Medical Devices Directive (MDD) and DAMAS requirements, and how the dental laboratory can ensure they remain compliant.

Can a dentist issue its own prescription to the laboratory?

MDD requirements for information supplied by the prescriber (dentist):

The MDD states that a custom made device must be specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The prescription may also be made out by any other person authorised by virtue of his professional qualifications to do so.

To put it simply, information must be sent by the prescriber (dentist) to the manufacturer (lab), which details the requirements of the appliances to be made. The directive does not extent its scope to specify the prescription appearance or structure, nor does it state that the blank prescription should be initially supplied by the manufacturer (although historically this is what usually happens).

Therefore, as far as MDD compliance is concerned, there are no issues with a dentist providing a laboratory with their own style prescription.

If your dentist has chosen to send in prescription requirements using their own style prescription, you must ensure the following:

• Keep a copy of the dentist’s prescription for your records for 5 years
• Ensure that you continue to have evidence of final inspection and, where appropriate, in-process inspection checks.
• Ensure that completed appliances are returned back to the dentist with a copy of the laboratory’s delivery documentation, which contains the   correct MDD labelling and statement requirements. For example, this could be your current lab ticket which you have completed, or a statement printed from a computer system.

Laboratory documentation which must be delivered with finished appliances

Whether or not the dentist has used their own style laboratory prescription, it is a requirement that the manufacturer must supply a statement with the finished appliance. This statement must also be structured so it can be made available to the patient by the healthcare professional who writes the prescription.

There are no strict guidelines on how the statement should be presented, however, it is compulsory for the following details to be present:

• Name and address of laboratory
• Patient name
• Description of device
• Name of prescriber and, if applicable, address of clinic
• The Statement of Conformity

If you have any questions about laboratory prescriptions, please telephone or email the DLA office.

How to claim DAMAS CPD

If you have used the DLA system to implement DAMAS and have completed your first external audit of the system you will be able to claim verifiable CPD.  The table below illustrates what verifiable hours are available.

If you are already DAMAS registered, any new staff will also be eligible to claim verifiable CPD, once trained in the DAMAS system. To enable you to issue verifiable CPD to your staff you need to follow certain steps to ensure that it meets the requirements of the GDC. For members of the DLA all the following information is available on the member’s only section of the DAMAS website to enable you to issue your staff with verifiable CPD:

– CPD Checklist

– CPD Aims & Objectives

– CPD Feedback Forms

– CPD Guidance Notes

 Continual professional development hours for persons involved with a project to establish and maintain a DAMAS Compliance System

In order to claim DAMAS CPD once you have become DAMAS registered all you need to do is contact the DAMAS office at the DLA who will supply the relevant documents for you to complete so you can obtain your CPD certificate.

For further information on becoming a DAMAS laboratory or for help on obtaining CPD for your DAMAS system please contact the DLA on 0115 9254888.

On the 11 February 2015 the MHRA will be introducing the Devices Online Registration System (DORS) which is a new online system for registration of medical devices. The new system will enable manufacturers and/or designated authorised representatives who place and put into service class I medical devices, systems and procedure packs, custom made medical devices, custom made active implantable devices and/or in vitro diagnostic devices on the UK market to submit their registrations to the MHRA electronically.

The link to DORS will be available on the following webpage from the 11 February 2015:

https://aic.mhra.gov.uk/era/drsystem.nsf/login.

To submit a registration via DORS, you will need to create an online account with a secure password beforehand. You may create an online account in two simple steps:

1. On the home page of DORS select ‘Create Account’ from the left hand menu. On being requested to identify the type of organisation that you are, please indicate whether you are a manufacturer, authorised representative or assembler.
2. On the next page you will be requested to input your contact details. Complete as many fields as possible and ensure that all fields that are marked with a red asterisk are correct. Please then read the terms and conditions, tick the box to confirm that you accept these, and click on the submit box.

The MHRA will check your details and email you when the account is activated. You will then be able to log in to DORS and start a new registration.  However, if the MHRA identify an anomaly with the account application, they will contact you for clarification before activating.

If you are already registered with the MHRA, you will only have to create an online account when you make a change to your details or register a new device.

Please note that there has been no change to the requirement to submit to the UK competent authority, for new and subsequent changes to the registered details held, the statutory fee of £70.00.

For any help with the online process the DLA have flowcharts available for members which are step by step guides for the on the Online Registration process. They include information on amending an existing registration.

The MHRA will stop accepting paper registrations on 11 May 2015. After this date you must register online using DORS to submit a registration to the MHRA.  Additionally, any hard copy registrations received up to and including the 11 May 2015 will be processed as per normal until the notification submitted to the Agency has been processed or closed.

For any questions relating to the new online system you can contact the MHRA via email: device.registrations@mhra.gsi.gov.uk  or by phone using the dedicated Fault/Problems phone line 0203 080 6666.

DLA Update – Sharon Ranshaw

I frequently find that many lab tickets do not conform to the Medical Devices Directive (MDD) statement of conformity and labelling requirements. Typical errors are: the words ‘custom-made’ missing; conformity statement missing or incorrectly worded; the words ‘intended for exclusive use by’ missing.

The following information is going over old ground for some of you, but there is no harm in reminding labs what should be on lab tickets and making some suggestions on how to meet the requirements.

Information supplied by the manufacturer – labelling and statement requirements

Labelling – The minimum requirements for a dental lab are: the name or trade name and address of the lab; the details strictly necessary for the user to identify the device; the words ‘custom-made device’; any special storage and/or handling conditions and any warnings and/or precautions to take.

I know this is stating the obvious, but the lab ticket must have the lab’s name and address on it. There should be a field to record the dentist’s name and where applicable, the clinic name and address; a field to record the patient’s name; a field to record the design requirements of the appliance and the words ‘custom-made device’. It is up to the lab to decide if there should be any special storage and/or handling conditions and any warnings and/or precautions to take.

Statement – The laboratory statement must contain the following information for custom-made devices:

• Name & address of the manufacturer
• Description of the device and any specific characteristics as indicated in the prescription
• The name of the prescriber and if applicable the address of the clinic
• A statement that the device is a custom-made dental appliance and intended for exclusive use by a particular patient, together with the name of the patient
• A statement that the device in question conforms to the essential requirements set out in Annex I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds;

Therefore an example of a suitable statement including all of the above requirements could be “This is a custom-made medical device that has been manufactured to satisfy the design characteristics and properties specified by the prescriber for the above named patient.  This medical device is intended for exclusive use by this patient and conforms to the relevant essential requirements specified in Annex I of the Medical Devices Directive and the United Kingdom Medical Devices Regulations”.

Note how Annex I is spelt; it should not be referred to as Annexe 1.

It is usually a good idea to add an additional statement to cover repairs and additions etc. for example: “This statement does not apply to medical devices that have been repaired and/or refurbished for an individual patient’s use.”

If you use computer software to generate your label and conformity statement, e.g. as part of your invoicing system, then the above MDD requirements still apply and you should ensure that the label and conformity statement satisfy these requirements.

Patient Statement

It is a requirement that the manufacturer must supply a statement with the finished appliances so it can be made available to the patient by the healthcare professional who writes the prescription.

There are no strict guidelines on how the patient statement should be presented, however, it is compulsory for the following details to be present:

• Name & Address of Laboratory
• Patient name
• Description of device
• Names of prescriber and if applicable address of clinic
• The Statement of Conformity

The laboratory should decide the most appropriate method for the patient statement which can include for example – a separate patient statement or a triplicate of the lab ticket.

A reminder about your Competent Authority registration number, i.e. the number allocated to you when you registered with the then, Medical Devices Agency or the now, Medicines and Healthcare Products Regulatory Agency. There is no specific requirement for this number to be on your lab ticket but it is good practice to do so. Many dentists are now asking labs for their CA registration number – as part of the dentist’s quality system – and it helps if the number is clearly on display. The display of this reference should state for example – UK CA Registration Number or MHRA Registration Number or a suitable abbreviation e.g. CA Reg. No., MHRA Reg. No.

So does your lab ticket adequately address the MDD labelling and conformity statement requirements? If not, get them corrected as soon as possible as they are legal requirements. I am always willing to review lab ticket artwork for labs and to make suggestions for correcting any errors or omissions in the artwork.