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Who should apply/register with the Competent Authority?
The EEA Competent Authorities usually charge fees for the registration/notification.
For General Medical Devices:
You must register with the Competent Authority in an EEA Member State in which you have your registered place of business if you:manufacture class I or custom made devices and place them on the market under your own name, or trading name(s); fully refurbish class I devices, or label one or more ready made devices, with a view to placing them on the market under your own name; place devices bearing the CE marking on the market, under your own name in a system or a procedure pack within their intended purposes and within the limits of uses specified by their original manufacturers; sterilise, for the purpose of placing on the market under your own name, systems or procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use; are the authorised representative of a manufacturer who does not have a registered place of business in the EEA.
If you do not have a registered place of business in the EEA Member State you must designate an authorised representative established in the EEA to act on your behalf.
Custom Made Devices mean devices manufactured in accordance with a professional's written prescription for the sole use of a particular patient and are not adapted from mass produced items.
For In Vitro Diagnostic Medical Devices (IVDs):
You must register with one Competent Authority in a Member State in which you
have your registered place of business if you: manufacture in vitro diagnostic medical devices (IVDs) and place them on the market under your own name, or trading name(s); manufacture IVDs for performance evaluation and make them available under your own name, or trading name(s); are the authorised representative of a manufacturer who does not have a registered place of business in the Community.
If you do not have a registered place of business in a Member State and you wish to place IVDs on the European market then you must designate a person established in the Community to act on your behalf as your Authorised Representative.
For Active Implantable Medical Devices
Directive 2007/47/EC amends the Active Implantable Medical Devices Directive 90/385/EC and came into force on 21 December 2008. One change to the directive especially affects persons responsible for placing and putting into service custom made active implantable medical device(s) on the EU market.
Article 1.11 of Directive 2007/47/EC amends Article 10 of Directive 90/385/EC to include a requirement for manufacturers of custom made active implantable medical devices to provide the Competent Authority of the member state in which they have their registered place of business details of their address, a description of the device(s) concerned, the product labelling and the instructions for use.
Why must I inform/notify/register with the Competent Authority?
Legal basis: All the three EU directives concerning medical devices, i.e., the Medical Devices Directive (MDD 93/42/EEC amended by 2007/47/EC)*, In Vitro Diagnostic Device Directive (IVDD 98/79/EC)**, and Active Implantable Medical Devices Directive (AIMDD 90/385/EC) *** require manufacturers or, their authorised representatives or others placing medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where they have a registered place of business.
Article 14 of Directive MDD 93/42/EEC amended by 2007/47/EC;
Article 10 of Directive IVDD 98/79/EC;
*** Article 10 of Directive AIMDD 90/385/EC.
These requirements have been transposed into national laws of the EEA Member States. In UK, the national law isMedical Device Regulations 2002: Regulations 19 and 44 registration of persons placing general medical devices and/or in vitro diagnostic medical devices on the market.
After the receipt of the notification/registration, the Competent Authorities shall process the data and inform the Commission of the European Communities and the other States Party to the Agreement on the European Economic Area, upon request.
What about changes to registered details?
After the product registration or notification, the manufacturer or its authorised representative must inform the Competent Authority about any changes or additions to the registered details.
Additionally, the Competent Authority will regularly review the records and request updating/confirmation of the registered information. The EEA Competent Authorities usually charge a fee for the product updating (change of registration).
Change Of Circumstance (COC)
In case of change of circumstance, the MHRA will establish whether the allocation of a new registration number is appropriate any registration where there has been a change of company name, or become a limited company; the manufacturer must provide written confirmation stating whether there has been/has not been a change in the legal entity of the business, e.g. enough changes to the operations/structure of the company, as to be wholly different to the previous registration.
Role of European Authorised Representative (Authorized Representative) in MHRA registration
Any manufacturer based outside the European Economic Area (EEA) (EU + EFTA excluding Switzerland) must designate an Authorised Representative (Authorized Representative) (AR). The appointed AR must file the required registration with the competent authority MHRA on behalf of the non-EEA manufacturer. When submit the registration with MHRA, the appointed AR must provide written evidence that they are acting with the consent of a manufacturer located outside the EEA. This may take the form of a Letter Of Designation or contract from the non-EEA manufacturer.
The letter should state the full name and address of the AR and that they are the designated EU authorised representative based within the UK, under the MDD 93/42EC. In the case of a notification/registration for an in vitro diagnostic device please quote the Directive IVDD 98/79EC.
In the case of an overseas manufacturer employing a new AR; the UK competent authority Medicines & Healthcare products Regulatory Agency (MHRA) will require a copy of the letter from the
non-EEA manufacturer, to the old AR terminating their services, and the date the service/contact is due to end.
As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC.
*Article 14.2 of Council Directive 93/42/EEC as amended by Directive 2007/47/EC:
Where a manufacturer who places a device on the market under his own name does not have a registered
place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall
inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.
Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
The IVD Directive (98/79/EC) groups IVDs into four categories. These categories are, in order of increasing perceived risk:
Other/General Device: all devices except Annex II and self-testing devices;
Device for Self-Testing (not listed in Annex II): a device intended by the manufacturer to be able to be used by lay persons in a home environment, excluding self-test devices covered in Annex II;
Device of List B, Annex II of the Directive: which, amongst others, includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self testing for blood sugar;
Device of List A, Annex II of the Directive: which includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.
Which classification does a Medical Device (MD) fall into?
A medical device (MD) may be classified as Class I (including Is & Im), Class IIa, IIb and III, with
Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIband III medical devices require the intervention of
third party: the so-called Notified Body.
The classification rules are set out in Annex IX of the directive. This annex includes definitions of the
terminology used in the classification rules. Classification of a medical device will depend up on a series of factors, including:
how long the device is intended to be in continuous use whether or not the device is invasive or surgically invasive, whether the device is implantable or active whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
It is usually the Intended Purpose for Use that determines the class of the medical device and not the particular technical characteristics of the device.
It is the Intended Purpose for Use, assigned by the manufacturer to the device, that determines the class of the medical device and not the class assigned to other similar products manufactured by the same manufacturer or different manufacturers. For instance, two sutures that have the same composition may well have different Intended Purpose.
A manufacturer may successfully avoid the particular higher classification by clearly define on the labelling the Intended Purpose in such a way that the device falls into the lower class!
Cost and fees for the registration of medical devices with MHRA
The cost and fees involved in the CE marking of Medical Devices will normally include the follows:
1. Certification Fees charged by Notified Bodies
Notified Bodies always charge fees for issuing EC Certifications, the fees charged by the Notified Bodies, which are in general profit-driven organizations in the private sector, varies from Notified Body to Notified Body, from country to country.
2. Official Fees charged by governmental Competent Authorities
The EEA Competent Authorities, which are in general non-profit governmental agencies in the public sector, normally charge fees for the processing and administration of the registration/notification of manufacturers and devices of MDs/IVDs. The procedures and official fees vary greatly from Member State to Member State among the 30 EEA countries.
o in UK,
the Competent Authority MHRA charges a statutory fee of 70GBP (about US$120) each time for registration, notification, update or change of the registration details held with the MHRA.
o in Spain, the Competent Authority charges a fee starting at 455.12Euro (about US$705) per product for registration/notification;
o in Sweden,
the Competent Authority charges annually a Registration Fee of 2150SEK (about US$320) per manufacturer, plus a Registration Fee, based on number of products, starting at 1000SEK (about US$150) for 1 to 10 products.
Authorised Representative Fees
Non-EEA manufacturers MUST appoint an Authorised Representative who has a registered business in EEA countries. Eulinx is proudly present you with high-standard of services at competitive prices.
When to inform/notify/register with the Competent Authority?
For General Medical Devices:
You must inform the Competent Authority when you first apply the CE marking to your class I device(s). If you have a number of models and the CE marking procedure is being introduced over a period, you may if you wish, inform the Competent Authority of all devices when informing of the first CE marking.
Manufacturers of custom-made devices, systems or procedure packs, and sterilisation companies, should registerno later than the first time they claim compliance with the Directive.
For In Vitro Diagnostic Medical Devices (IVDs):
For In Vitro Diagnostic Medical Devices there is a transitional period until 7 December 2003
in respect of a device placed on the market and a transitional period until 7 December 2005 in respect of a device put into service, during which a manufacturer can choose either to follow existing national regulations to apply the CE mark. You must inform the Competent Authority when you first apply the CE
marking to your IVDs.