93/42/EEC MDD CE Certification Consultancy

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.

Medical devices cannot be placed into the market before the CE is affixed. Organizing and conducting the CE Certification process of medical devices require a disciplined and planned work. The person who will conduct and consult during this process must be experienced and knowledgeable. The decision on the medical device CE Certification consultant directly affects and either accelerates and decelerates the certification process. Before choosing your medical device CE Certification consultant;
– Learn whether your medical device CE Certification consultant has ever worked with the same or similar product type.
– Learn the English proficiency of your medical device CE Certification consultant. Most of the CE Standards that you must use as a guide are to conduct your processes are in English. Furthermore, most of the clinical investigations and post marketing studies of equivalent devices which will be necessary to construct your technical file are also in English. Thus, your consultant’s proficiency in English is very important.
– Learn which notified buddies has your consultant worked with? Every notified body has a unique understanding of certification. Hence, it is important that your consultant is familiar with the notified body that you will be working with.
– Your medical device CE Certification consultant is the person who will train your quality team. For your team to be active and efficient during the CE Certification process, your team must get;
o ISO 13485 Standard Informational, Certification and Internal Audit Trainings
o 93/42 EEC Medical Device Directive Informational Training
o ISO 14971 Risk Analysis Training
o Meddev 2.7.1 Clinical Evaluation Training
o Meddev 2.12.1 and 2.12.2 Post Market Surveillance Training.
Make sure that your medical device CE Certification consultant already had these trainings.

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;
Devices that fit to this definition are categorized as medical device and they must be produced in compliance with 93/42 Medical Device Directive and marked with CE.

In order to affix the CE mark to the device in compliance with the Medical Device 93/42 EEC (AT) Directive, first, the product must be classified into its risk group. In this step, depending on your product, sometimes a declaration from the manufacturer is enough to be able to affix the CE mark; whereas sometimes, the approval of a notified body is required. To conduct the certification process right, deciding which risk group that your medical device fits into with your consultant is one of the key steps.

To determine the risk group of a medical device, 93/42 EEC (AT) Medical Device Directive must be taken as a basis. According to 93/42 EEC (AT) Medical Device Directive, medical devices are categorized into risk groups depending on where in the body and for how long do they contact. Besides this, electrical medical devices are categorized based on the potential risks that they have as they function. According to the definitions in the directive, products are categorized into 4 risk groups;
Class I – It is considered as the low risk group. Devices in this group most of the time contact with the surface of the body for a short period of time. Exp: Non-sterile urine collection bag, wound drainage bags, cloth aprons, plasters, reusable hand tools.
Class II a – It is considered as the medium risk group. Most of the Class II a devices partially or fully contact, enter or place inside the body through the body cavities or by passing through the surface of the skin for a short period of time. Besides this, devices that exchange body fluids, give medication to the patients and store body fluids or organs are also considered as Class II a. Exp: Injectors, catheter sets, guide wires, bisturi, gauze patches, wound care products, dental alloys, dental bridges, dental ceramics, dental and orthopedic drills, fillings that are placed on the surface of the teeth.
Besides this, electrical medical devices that do not possess a potential risk depending on how it is used its action mechanism, are also categorized as Class II a. Exp: Surgical motors, muscle stimulators, hearing aids, nebulizer, sleep apnea devices, phototherapy devices.
Class II b – It is considered as the medium risk group. Most of the Class II b devices partially or fully contact, enter or place inside the body through the body cavities or by passing through the surface of the skin for a longer period of time. Exp: Hemodialysis solutions, orthopedic or trauma implants (plate, screw, nail, external fixators, kirschner and cerclage wires etc.), dental implants (abutments, screws), spinal implants(screws, plates, rods, cages, cage systems, disc prothesis etc.), sutures, ligation clips, meshes, preservatives, staplers, shunts, stents, contact tracheal cannulas, insulin pens, lenses, textiles that contact with chronic ulcer wounds, blood bags.
Besides this, electrical medical devices that possess potential risks based on how they are used and their action mechanism. Exp: Lung ventilators, blood heaters, high frequency electrosurgical generators, pacemakers and defibrillators, surgical laser devices, electrodes, digital imaging systems (X-ray), blood pressure monitoring systems, hyperbaric rooms, sterilizers, cleaning-disinfection devices, medical gas centrals.
Class III – It is considered as the high risk group. Most of the Class III devices are devices that are either in contact with critical parts of the human body such as the circulatory system and the central nervous system or replace an organ or has medicine, human blood or animal origin and can be absorbed by the body. Exp: Central venous catheters, angioplasty balloon catheters, neurological catheters, brain pads, guide wires, stents, epidural needles, anticoagulants, hyaluronic acids, ligatures, absorbable sutures, meshes, prosthetic heart valves, vascular prosthesis, vena cava filters, knee prosthesis, hip prosthesis, shoulder prosthesis, breast implants, contraceptive intrauterine implants, implants with silver, wound care products with silver, catheters with drug.
From all the devices that are classified under these groups;
Product Risk Group
Should I get an ISO 13485 Certificate?
Should I get a CE Certificate? / Should I get audited by a notified body?
Class I
Yes
Technical file must be constructed. Declaration from the manufacturer is enough. (Declaration of Conformity). It is not required to get audited by a notified body.
Class Is (sterile)
Yes
Must go through the audit of the notified body and get CE Certification.

Class Im (measuring function)
Yes
Must go through the audit of the notified body and get CE Certification.
Class II a
Yes
Must go through the audit of the notified body and get CE Certification.
Class II b
Yes
Must go through the audit of the notified body and get CE Certification.
Class III
Yes
Must go through the audit of the notified body and get CE Certification.

It is very important to determine the risk class of your device for many different aspects.
It determines the rigidity of ISO 13485 Quality Management System and 93/42 EEC (AT) Technical File.
As the risk class of the product gets higher, the number of verification and validation parameters increase.
Depending on the risk class of the product, the length of the audit is determined. As the duration of the audit increases, the price of the certification increases.
Depending on the risk class of the product, the price of the consulting service is determined. As the risk class of the product gets higher, the duration of the consulting services and the work that must be done to construct a technical file increase.

As the risk class of the product is determined according to 93/42 EEC (AT) Medical Device Directive, the safety and performance tests that must be done on your device will be determined. (Biocompatibility tests, biomechanics tests, electrical safety and performance tests, shelf life, sterilization, validation tests etc.) This way, the topics that construct the basis of the technical file will be clarified. After determining the necessary tests, work to construct the technical file in compliance with 93/42 EEC(AT) Directive in order to get the CE Certification will be continued with the lead of our consultants.

Technical files that are prepared in consideration of the requirements of 93/42 EEC (AT) Medical Device Directive and the intended purpose of the product compose the technical file. Regardless of the risk class of the device, the requirements of the standard about the manufacturer and the properties of the product must be taken into consideration when constructing the technical file.
The content of the Technical File is determined in the 21805007 numbered announcement of the Ministry of Health. According to this, things that must be in the technical file include but not limited to;
Name and address of the manufacturer, address of the production and design area
Declaration of Conformity
European Representative
GMDN Code
Production Flow Diagram
List of machines that are used in the production
ISO Certificates of Raw Material Suppliers
Clear description of the device, if there is, clear description of its alternative models and accessories
The intended use of the device
Label
User’s manual
Classification of the device and its justification
List of applied standards
Medical Device Directive/ Basic Requirements (93/42/EEC, Annex-1)
Risk analysis
Pre-clinical evaluation
Shelf life, stability studies, packaging validation
Technical properties of the product
List of components used and conformity certificates of materials used

Technical drawings when necessary
Information on the production processes, special processes, flow diagrams, used records etc.
Sterilization and Validation when necessary
Design processes
Specifications (certification, test reports, data sheets etc.)
Information on critical suppliers
Biocompatibility test reports when necessary (with compliance to ISO 10993 Standard)
Product test reports
Clinical data
Data of the equivalent product
Scientific literature data and its evaluation
Evaluation of clinical investigation results
Competency of people who report (must have their CV’s in the file.)

Clinical Evaluation Report
Work to construct the technical file in compliance with 93/42 EEC(AT) Directive in order to get the CE Certification is continued with the lead of our consultants.

The time that it takes to construct a technical file in compliance to the requirements of ISO 13485 Quality Management System and the requirements of 93/ 42 EEC(AT) Medical Device Directive depends on the structure of the firm, and the necessary verification and validation studies which are determined according to the intended purpose of the device. Most of the time, the technical file is not sent to the notified body to be reviewed before all of its verification and validation studies are done. Depending on the answers of the questions below, the time that it takes to construct a technical file changes.
Are there any employees who have been involved in the documentation process at the firm?
Is the infrastructure of the firm ready to produce, store and preserve the product?
Are the necessary biocompatibility, biomechanics and electrical safety and performance tests determined and conducted?
How is the product presented to the market? (sterile or is it going to be sterilized by the user)
Are the studies to determine the product’s life conducted?
Example: You want to certify an orthopedic-trauma intramedullar nail. Necessary verification and validation studies and their estimated durations are as stated below.
Verification and Validation Studies
Duration
Biocompatibility Tests
4-6 months

Biomechanics Tests
Approximately 2 months
Shelf Life Tests
20-32 days for every year, +20 days
Exp: If the shelf life is going to be for 5 years, completing all the tests will take 6 months.
Other verification and validation studies
Other verification and validation studies can be conducted as the studies mentioned above are continued.
All of your work for 93/42 EEC (AT) Medical Device Directive and ISO 13485 Quality Management System Standard will be planned and conducted with the lead of our professional consultants. Your project will continue until your ISO 13485 and CE Certification is done.

Before finishing to construct the Quality Management System in compliance to the requirements of ISO 13485 Standard and the Technical File in compliance to the requirements 93/42 EEC (AT) Medical Device Directive, the notified body that will audit the firm must be chosen.
Currently, there are 5 Notified Buddies in Turkey. These are;
– UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi Sanayi ve Ticaret Anonim Şirketi, Ankara (CE 2292)
– Szutest Uygunluk Değerlendirme A.Ş., İstanbul (CE 2195)
–
– Kiwa Belgelendirme Hizmetleri A.Ş., İstanbul (CE 1984)
–
– Türk Standartlar Enstitüsü, Ankara (CE 1783)
–
– Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi, İstanbul (CE 2764)
Click for notified buddies that can do CE Certification under 93/42 EEC (AT) Medical Device Directive
by European Committee.

No, one medical device can only be certified by one notified body at a certain time. This case is defined in the 93/42 Medical Device Directive conformity evaluation module;
Manufacturer applies to a notified body to get its quality management system evaluated. This application includes:
Declaration that confirms there is no other application done to another notified body for this medical device

During the auditing process conducted by the notified body, nonconformities with the requirements of relevant directives and standards might be identified. These nonconformities are reported to the firm through nonconformity reports. It is very normal for the nonconformities to be identified during an audit. After nonconformities that were reported to the firm are closed, the work done is reported to the notified body. The audit team who has conducted the initial audit investigates the work done to close the nonconformities, and they either approve the work or send it back to the firm to be rereviewed. When the closure of nonconformities are done, the audit file is reviewed by an unbiased committee formed by the notified body. If the committee makes a positive decision, the firm earns the right to receive the ISO 13485 and CE Certification. The certifications that will be given to the firm are sent as a draft and their approvals are requested. After the firm approves the drafts of the certifications, the certifications are press printed and sent to the firm.

During the auditing process conducted by the notified body, nonconformities with the requirements of relevant directives and standards might be identified. These nonconformities are reported to the firm through nonconformity reports. It is very normal for the nonconformities to be identified during an audit. After nonconformities that were reported to the firm are closed, the work done is reported to the notified body. The audit team who has conducted the initial audit investigates the work done to close the nonconformities, and they either approve the work or send it back to the firm to be rereviewed. When the closure of nonconformities are done, the audit file is reviewed by an unbiased committee formed by the notified body. If the committee makes a positive decision, the firm earns the right to receive the ISO 13485 and CE Certification. The certifications that will be given to the firm are sent as a draft and their approvals are requested. After the firm approves the drafts of the certifications, the certifications are press printed and sent to the firm.