Date posted: May 16, 2016
Many dental laboratory owners will remember the changes to the Medical Devices Directive that came into force in March 2010 which included changes such as the patient statement and a legal requirement to record complaints. But were you aware that as part of these changes the registration details of manufacturers including dental laboratories changed from being confidential to that of a public register.
Prior to 2010 all manufacturers that were registered with the MHRA were written to and informed that information held by the MHRA would no longer be confidential and as part of the process of releasing this information on a public register manufacturers had to confirm their registration details.
The letter sent out by the MHRA required that all dental laboratories confirm their registration information was correct and that continued registration was required by the laboratory. This confirmation by the dental laboratory was required in writing. Essentially if no confirmation was received from the dental laboratory manufacturer by the MHRA prior to the deadline in 2009 then the MHRA archived the laboratory registration and considered the laboratory to be no longer registered.
If you had moved business premises since your first registration with the MHRA which was previously named the Medical Devices Agency (MDA) and you didn’t inform the MHRA you would not have received this letter and you may not now be registered.
It is essential that all manufacturers verify their registration to ensure that the dental laboratory is registered and that the registration details are correct and up to date.
To check if your dental laboratory registration is current visit the following link which will take you directly to the register for dental appliances, alternatively you may visit the MHRA website and undertake a general search using the following wording ‘Access to the Medical Devices Register’:
http://aic.mhra.gov.uk/era/pdr.nsf/devicecode?openpage&RestrictToCategory=K1&start=1&count=200
If your dental laboratory information is incorrect or out of date then you will need to rectify this by accessing the MHRA’s Devices Online Registration System (DORS). This online registration system can be accessed at https://aic.mhra.gov.uk/era/drsystem.nsf/login . Once your account is activated by the MHRA you will be able to make the necessary changes. Please note that for new and subsequent changes to the registered details held by the MHRA, the statutory fee of £70.00 will be charged.
If you need help with any aspect of MHRA registration contact the DLA office on 0115 9254888
Date posted: May 6, 2016
For many years, GDC registrants have been required to have appropriate indemnity arrangements in place so that patients can claim any compensation to which they may be entitled. This requirement is part of the GDC Standards.
However, since July 2014, all registered healthcare professionals are legally required to have indemnity cover.
The GDC changed the registration rules so that dentists and dental care professionals applying for registration or restoration, and those renewing their registration each year, will be required to tell the GDC that they have indemnity cover in place – or will have by the time they start practising.
The idea behind the change is that you won’t be able to register or renew your registration unless you can confirm to us that you have, or will have, cover in place. This will reduce the number of people working without cover.
It’s important to note that the requirement to have appropriate indemnity cover is not new and has not changed. The main difference that current registrants will notice is that when you renew your registration through eGDC each year, you will have to confirm that you have indemnity cover in place, or will have when you start to practise. If you don’t confirm this, you will not be able to renew your registration.
Some people may be asked to provide details of their policy to the GDC when they are applying for registration, applying for restoration, or when renewing their registration during the ARF period. Each individual applicant or registrant will need to know the details of their indemnity cover, and to provide details of these to the GDC if asked to do so.
If you do not have your own indemnity cover, for example you are covered under your employer’s policy, you will need to make sure you have, or can access, the details of the policy if the GDC ask you to provide them. If you are a dental laboratory owner with DCPs covered under your policy, you will need to make the appropriate information available to them should they need it.
The first group of dental professionals to have to make this declaration will be DCPs during the ARF collection period in summer 2016.
For further information or to access frequently asked questions regarding indemnity insurance, you can visit the GDC website at:
http://www.gdc-uk.org/dentalprofessionals/standards/pages/indemnity.aspx
Date posted: August 12, 2015
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:
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:
If you have any questions about laboratory prescriptions, please telephone or email the DLA office.
Date posted: April 1, 2015
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:
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.
Date posted: March 27, 2015
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:
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:
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.
Date posted: December 19, 2014
It has come to the attention of the DLA that if you are an accredited supplier of Oasis Dental Care you may have received a letter from Oasis stating that you need to become a British Bite Mark member and either a DAMAS UK or ISO 9001 accredited member.
We wanted to let you know the easiest way to become DAMAS accredited, and inform you of the auditing time period which is required by DAMAS, as well as how simple it is to become a British Bite Mark member.
DAMAS
Firstly, becoming DAMAS accredited. The Oasis letter stipulated a deadline of 1st April 2015 to become DAMAS accredited. In order to meet this deadline you will need to look at implementing DAMAS now, as the DAMAS auditors require a 10-12 week auditing period. For instance, say we audited your laboratory on 10th March 2015 – in this case we would need to review your records from 10th December 2014.
The DLA is aware that many laboratories, although wishing to implement the DAMAS system, often struggle to put the basics in place. Therefore the DLA has designed a DAMAS Implementation System that is much easier and less time consuming in the initial stages to implement. This system has been designed for lab owners by lab owners and has been successfully implemented by hundreds of dental laboratories.
As with all quality systems, there will still be work to do to meet the DAMAS requirements, but the main bulk of the system will be set up for you in advance. The DAMAS Procedures Manual, which is the main area of the system, is already compiled for you – all you need to do is fine-tune it to ensure it describes what happens in your laboratory.
The ‘DAMAS Implementation System’ consists of:
As well as having all the information you need to hand, included as part of the package is unlimited telephone and email support from the DLA office.
It is our advice to book your DAMAS audit in as soon as possible for March/April, as DAMAS audit dates will be allocated on a first come first served basis. In order to meet the oasis deadline you need to have had your audit on or before the 1st April 2015.
Please allow at least 10 weeks’ notice to book your DAMAS audit.
The DLA office is closed for Christmas on 21st December at 12.30pm and re opening on 5th January at 9am .
If you decide that you want to be DAMAS accredited, please give the DLA office a ring on 0115 9254888 and they can talk you through the different options.
The British Bite Mark
Secondly, it is very simple to become a British Bite Mark member. The idea of the British Bite Mark was of a logo that identified custom made dental appliances manufactured in Britain. According to ‘Made in Britain’ research carried out in 2011, the British public was confused about which products were made in the UK. The DLA felt this was equally true for dental patients in the UK, who were receiving complex dental treatment without knowing where the appliances in their mouth had come from and to what standards they had been manufactured.
Therefore the DLA launched the British Bite Mark as a trademark that would help patients and professionals easily recognise that their custom made dental appliances had been manufactured in Britain to a set of high standards.
In terms of becoming a British Bite Mark member, this is FREE to all DLA members assuming you meet the criteria below:
I hereby certify that all custom made medical devices manufactured by the above named business are compliant with the rules of the Medical Devices Directive and the General Dental Council and that we are member of the Dental Laboratories Association.
In addition I accept that all products manufactured at this address meet the requirements of the British Bite Mark meaning that they have been wholly manufactured on site or have been subject to a substantial change at this site in the last phase of manufacturing.
The DLA office is closed for Christmas on 21st December at 12.30pm and re opening on 5th January at 9am .
If you have any further questions, give the DLA office a ring on 0115 9254888.
Yours sincerely,
The DLA team
