Medical Device CE Certification is a directive composed by the European Union Committee that all the medical device producers are obliged to comply. 93/42 EEC (AT) Medical Device Directive simply expects the determination of the safety and performance parameters that the product must meet (biocompatibility, biomechanics, sterility, shelf life, compliance to product specific standards) and the strategy that will be applied to meet these parameters. Additionally, it requires the validation of compliance to these parameters. All the studies done to validate the compliance to the parameters are put together in a technical file. After these requirements are met, the medical device can be marked with CE as it is described in Medical Device CE Certification. The firms compliance to 93/42/EEC (AT) Medical Device Directive is shown with Medical Device CE Certification. If the product is classified under a low risk group, the Declaration of Conformity written under the responsibility of the medical device producer is enough to present the medical device to the market.
Medical devices under medium and high risk groups require to get audited and approved by a notified body. Medical device producer earns the right to get a Medical Device CE Certification after successfully completing the notified body audit. Getting a professional Medical Device CE Certification Consulting support during a process that requires multi-perspective approach, knowledge on standard and directives and experience on the applications will help you to receive your Medical Device CE Certificate in optimum time, to improve your staff’s knowledge on quality, to understand the requirements of Medical Device CE Certification clearly and to apply them in an efficient and improvable manner without unnecessary spending.
TıbbiCE Consulting, Training and Validation Services, offers consulting, training and validation services to domestic and overseas medical device producers during their CE and ISO 13485 Certification (93/42/EEC) process. With its expert staff from different backgrounds including but not limited to biology and biomedical, mechanical and metallurgy engineering, TıbbiCE Consulting, Training and Validation Services is the medical device consulting company with the largest expert staff in Turkey.
TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.
- 93/42 EEC (AT) Directive Genaral Provisions
- Medical Device CE Certification Consulting
- What Is Medical Device Ce Certificate?
- How Can I Mark My Device With CE?
- How To Determine The Risk Group Of A Medical Device?
- Why Is It Important To Determine The Risk Class Of The Medical Device?
- What Is The Next Step After Determining The Risk Class Of The Medical Device?
- What is A Technical File?
- How Long Does İt Take To Construct A Technical File?
- Quality Management System And technical file is Ready To Be Audited
- Can A Medical Device Be Audited By More Than One Notified Body?
- Will I Get My Ce Certification Right After The Notified Body Audit?
- Can I Start The Sales Of My Product Right After The Certification
93/42 EEC (AT) DIRECTIVE GENERAL PROVISIONS
Purpose and Scope 93/42 EEC (AT) Medical Device Directive
(1) This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
(2) If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.
(3) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with this Directive.
(4) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a ‘human blood derivative’, that device shall be assessed and authorised in accordance with this Directive
This Directive shall not apply to:
(a) in vitro diagnostic devices;
(b) active implantable devices covered by Directive 90/385/EEC;
(c) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(d) cosmetic products covered by Directive 76/768/EEC (1);
(e) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in paragraph 4a;
(f) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
93/42 EEC (AT) Medical Device Directive Definitions
Article 3- (1) For the purposes of this Directive, the following definitions shall apply:
a) Accessory: an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
b) Device subcategory: a set of devices having common areas of intended use or common technology;
c) Putting into service: the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;
d) Custom-made device: Any device 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.
e) Human blood derivative: a medicinal product derived from human blood or human plasma
g) in vitro diagnostic medical device: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
f) Generic device group: a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
g) Device intended for clinical investigation: Any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
h) Clinical data: the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:
— clinical investigation(s) of the device concerned; or
— clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
i) Intended purpose: the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;
j) Placing on the market: the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
k) Single use device: a device intended to be used once only for a single patient.
l) Medical device: means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
m) Authorised representative: any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
Article (9)- 93/42 EEC (AT) Medical Device Directive Classification
1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.
2. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.
Article (10) - 1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:
(a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorized representative, is also informed of the incident
Article (11) - 93/42 EEC (AT) Medical Device Directive Conformity assessment procedures
1. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.
2. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either:
(a) the procedure relating to the EC verification set out in Annex IV; or
(b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
(c) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
3. In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or
(b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
(i) the procedure relating to the EC verification set out in Annex IV; or
(ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
(iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
4. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
(b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
(i) the procedure relating to the EC verification set out in Annex IV; or
(ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).
5. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market.
6. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.
7. The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, IV, VII and VIII.
8. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
9. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.
10. Decisions taken by the notified bodies in accordance with Annexes II, III, V and VI shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of a maximum length of five years.
11. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.
12. By derogation from paragraphs 1 to 6, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 6 have not been carried out and the use of which is in the interest of protection of health.
93/42 EEC (AT) Medical Device Directive – Clinical Investigations
1. In the case of devices intended for clinical investigations, the manufacturer or the authorized representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.
2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.
3. In the case of devices other than those referred to in paragraph 2, Member States may authorize manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favorable opinion on the programme of investigation in question including its review of the clinical investigation plan.
4. The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made subject to authorization from the competent authority.
5. The clinical investigations must be conducted in accordance with the provisions of Annex X.
6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.
7. The manufacturer or his authorized representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorized representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.
8. The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted using devices which are authorized in accordance with Article 11 to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. The relevant provisions of Annex X remain applicable.
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