Labeling Requirements for a Class 1 Exempt Medical Device

A

Achemd

Does anyone have a checklist for the min. labeling requirements for a class 1 exempt device that we want to sell to the UK? I believe it does not require a CE mark, am I correct?
Thanks :thanks:
 
G

Gert Sorensen

Does anyone have a checklist for the min. labeling requirements for a class 1 exempt device that we want to sell to the UK? I believe it does not require a CE mark, am I correct?
Thanks :thanks:

As far as I know all medical devices sold in Europe has to be CE-marked. :rolleyes:
 
V

Vassilis

I quote the following part of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices regarding CE Marking regardless the class of the product

"Article 17

CE marking

1. Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

2. The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging.

It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.

3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. "

Also in the same Directive in Annex A i quote

" 13. Information supplied by the manufacturer

13.1. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users.

This information comprises the details on the label and the data in the instructions for use.

As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices.

Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.

13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.

13.3. The label must bear the following particulars:

(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;

(b) the details strictly necessary for the user to identify the device and the contents of the packaging;

(c) where appropriate, the word 'STERILE';

(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;

(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single use;

(g) if the device is costum-made, the words 'custom-made device';

(h) if the device is intended for clinical investigations, the words 'exclusively for clinical investigations';

(i) any special storage and/or handling conditions;

(j) any special operating instructions;

(k) any warnings and/or precautions to take;

(l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization.

13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use.

13.5. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components.

13.6. Where appropriate, the instructions for use must contain the following particulars:

(a) the details referred to in Section 13.3, with the exception of (d) and (e);

(b) the performances referred to in Section 3 and any undesirable side-effects;

(c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination;

(d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in connection with implantation of the device;

(f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment;

(g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of resterilization;

(h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be resterilized, and any restriction on the number of reuses.

Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be such that, if correctly followed, the device will still comply with the requirements in Section I;

(i) details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular:

(k) precautions to be taken in the event of changes in the performance of the device;

(l) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks related to the disposal of the device;

(o) medicinal substances incorporated into the device as an integral part in accordance with Section 7.4;

(p) degree of accuracy claimed for devices with a measuring function. "

For complete Council Directive 93/42/EEC of 14 June 1993 concerning medical devices check the following http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:NOT

I hope that i have helped you!:bigwave:
 
G

gereard_kgb

As a general rule it seams that any medical devices sold in the EU MUST be CE marked.

It's also important to use apropriate languages. In case the products is sold to the UK English should be fine but, IMHO, one should consider Welsch as well.

:)

Any way, the label (and instruction for use) is very important so it must be prepared very carefully.
And of course it case of a manufacturer is located outside of the EU he needs an authorised representative.
It's worth reminding that class I products need to be registered with MHRA in case the AR (or manufacturer) is located within the UK.
 
R

Rover

As a general rule it seams that any medical devices sold in the EU MUST be CE marked.

It's also important to use apropriate languages. In case the products is sold to the UK English should be fine but, IMHO, one should consider Welsch as well.

:)

Any way, the label (and instruction for use) is very important so it must be prepared very carefully.
And of course it case of a manufacturer is located outside of the EU he needs an authorised representative.
It's worth reminding that class I products need to be registered with MHRA in case the AR (or manufacturer) is located within the UK.

How to find authorised representative and make contract?:(
 
G

gereard_kgb

Various representatives can be found on the Internet. if you type this name of google that should help.

I can offer this services from one of my own companies. Please feel free to contact me at your convenience at [email protected] if you'd like me to become your authorised rep. or give detailed help regarding the certification and CE certyfing process.

Hope this helps.
 

shaunkerrigan

Registered
Does anyone have a checklist for the min. labeling requirements for a class 1 exempt device that we want to sell to the UK? I believe it does not require a CE mark, am I correct?
Thanks :thanks:
You can self certify a class i device in the EU with a Declaration of Conformity. So it does need a CE mark however you can do it yourself. You do however need to register the device with the competent authority in the UK the MHRA. This may have changed since Brexit. Depending on the device it may change as a result of the MDR in May.
 
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