The Wójcik Design company specializing in the design of medical devices/equipments in its offer also has their certification, i.e. confirmation of compliance with all applicable essential requirements that apply to them
Certification procedure is not a secret for us, we do not need to learn the medical device – because we have designed it ourselves from scratch, we do not need to read with more (or less) understanding in technical documentation – because we have created it ourselves in accordance with applicable standards, we do not need to understand the instructions – because we wrote it ourselves according to the standards. And that’s why we can professionally certify medical devices/equipments .
Let’s start by explaining what certification is, how a medical device/equipment is classified and what is being done with it and why.
Certification of a medical device/equipment is in fact its introduction to the market in accordance with the requirements of EN ISO 13485: 2016 – preparation of technical documentation and its verification, preparation of a test article for compliance with EN 60601-1 and EMC tests, cooperation with external laboratories, conducting (authorization) of tests for compliance with specific standards, classification of a medical device, preparation of a list of harmonized standards, preparation of a medical device compliance checklist with the essential requirements of Directive 93/42 / EEC, determination of product lifetime, preparation of a device analysis report as PEMS, preparation of instructions acceptance of the product, list of critical elements and declarations of conformity, implementation of the Quality Management System compliant with the ISO 13485: 2016 standard, preparation of procedures in accordance with the standard, preparation of the quality book, testing for compliance with EN 60601-1, EMC test.
A medical device must be properly classified by a specific conformity assessment procedure so that it can be placed safely on the market. And yes, there are three classes (I, II a, II b and III) taking into account the risk of its use. So the basis for the classification of medical devices is the potential risk associated with the use of the product (duration of contact with the body, the place of contact, the degree of invasiveness, local or systemic effects) and possible inability to do so. The manufacturer classifies the classification of medical devices for a given class – see table below.
|orthopedic collars, test gloves, wheelchairs,
products with a measuring function,
|hydrogel dressings, disposable catheters, X-ray film,|
|blood containers, condoms, respirators,|
|breast implants, heart valves, vascular prostheses|
The classification of medical devices/equipments is therefore very important, because it depends on it to ensure that the assessed medical device meets the essential requirements. The higher the product class, the more restrictive conformity assessment procedure.
In addition, there are 18 rules for classifying medical devices, where: 1-4 refers to non-invasive medical devices, 5-8 refers to invasive medical devices, 9-12 applies to active medical devices, and 13-18 are special rules. Classification rules should be followed in the intended use of the medical device.
Act of 20 May 2010 on medical devices (U. of 2017, item 211 with later amendments) (U. z 2017 r., poz. 211 z późn. zm. )
Regulation of the Minister of Health of November 5, 2010 on the method of classifying medical devices (Journal of Laws No. 215, item 1416) (Dz.U. Nr 215, poz. 1416 )
Regulation of the Minister of Health of February 16, 2016 on the criteria for reporting incidents with products, the manner of reporting medical incidents and actions in the field of product safety (Journal of Laws item 201) (Dz.U, poz.201 )
For the medical devices industry , three basic directives are also used, which are described in the table below for easier understanding:
|MDD (Medical Device Directive) – 93/42 / EEC – directive for medical devices (referred to in Polish legislation as medical devices for various purposes)||According to the definition contained in Directive 93/43 / EEC, a medical device is:
‘A tool, apparatus, apparatus, equipment, material or other article used alone or in combination, including software necessary for the proper use of the device, intended by the manufacturer for human use for:
1) diagnosis, prevention, monitoring, treatment or alleviation of diseases, 2) diagnosis, monitoring, treatment, alleviation or compensation of injuries or impairments, 3) examination, replacement or modification of the anatomical structure or physiological process, 4) conception regulation,
which does not achieve its principal intended action in the body or body by pharmacological, immunological or metabolic means, but whose action can be supported by them “
|AIMD (Active Implantable Medical Device) – 90/385 / EEC – directive for active implanted medical devices||According to the definition in Directive 90/385 / EEC, active implantable medical devices include:
‘An active medical device intended for insertion into the human body and partially introduced into the body through surgery or through medical intervention into a natural opening and intended to remain there after completion of the procedure’
|IVD (In Vitro Diagnostic Device Directive) – 98/79 / EC – directive for in-vitro diagnostic medical devices.||According to the definition in Directive 98/79 / EC, in-vitro diagnostic medical devices include:
‘Medical device being a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system used alone or in combination, intended by the manufacturer for in vitro use, for testing samples taken from the human body, including samples blood or tissues of the donor, exclusively or primarily to provide information: 1) physiological or pathological condition, 2) referring to congenital defects, 3) indicating safety and compliance with the potential recipient, 4) enabling supervision of therapeutic activities.
In vitro diagnostic medical devices also include vacuum containers for samples and others intended by the manufacturer for the direct storage and maintenance of human body samples for in vitro diagnostic testing
In vitro diagnostic medical devices also include general laboratory equipment if, because of its properties, it is specifically intended by the manufacturer for in vitro diagnostic testing. “
The wording “intended by the manufacturer” deserves attention in the quoted definitions, which means that whether the product is or is not a medical device deserves the destiny given by the manufacturer. For example, use scissors, which can be a medical device if the manufacturer gives them such a purpose, or can be sold as a non-medical product – for tailoring services, home or school needs.
Many products “meet” the definition of a medical device, and the decision whether it is a medical device or not is made by the manufacturer.
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (UPRL) may, however, refuse to enter such a product in its register. In practice, some of the products at issue can be classified based on experience from EU member states.
The final destination is given to the product by the manufacturer; if it does not indicate medical use, they are not subject to the directives: MDD (such products as: contact lenses for aesthetic purposes [without corrective function], diapers for babies, gymnastic equipment, toothbrushes and toothpicks, dental floss, cosmetics), AIMD (products very technologically advanced, such as pacemakers or implanted insulin pumps, their assessment is similar to other medical devices in class III), IVD (products not in direct contact with the patient. Essential requirements for these products are slightly different from MDD and concern First of all, diagnostic parameters. The way in which they are assessed [with the exception of a limited group of products with increased risk and products for independent use] is similar to MDD class I medical devices).
However, medical devices are divided into classes I, IIa, IIb, III with regard to such criteria as: invasiveness, time of continuous contact with the patient, type of contact with the patient, active / passive devices, special rules. These rules are contained in Annex IX of the MDD Directive (as well as in the MZ Regulation).
In order to place a medical device on the market, he must undergo a conformity assessment procedure that will confirm whether the product meets all the essential requirements for this product. This procedure is carried out depending on the class of the medical device, which shows the risk of its use. For first class medical devices (ie non-sterile products and no measuring function) – the manufacturer independently performs conformity assessment, issues a declaration of conformity and labels his product with the CE mark. For products with higher risk classes – the notified body must participate in the conformity assessment procedure. For this purpose, the manufacturer can turn to our company Wójcik Design, which will professionally carry out the entire procedure. At the beginning, he will prepare a medical device for certification. The ISO 13485 system is most often introduced by manufacturers of medical devices for the purpose of assessing compliance with Directive 93/42 / EEC, but other companies in the medical devices industry, eg service companies or suppliers of critical components for medical equipment manufacturers, may also use it. In modules using the quality management system assessment for product evaluation (assessment according to Annex II, V of the MDD directive), the current harmonized standard is EN ISO 13485 (available in Poland as PN-EN ISO 13485). In addition to the requirements typical of quality management systems, this standard regulates many formal issues set out in the MDD directive, such as: technical documentation, reference to legal requirements, product risk management, detailed requirements for product implementation, environment and personnel rights.
The implementation of the quality management system according to ISO 13485 is carried out in a similar way as other quality systems, eg systems according to of the popular ISO 9001 standard. Usually, the initial stage of implementation is the assessment of the current solutions adopted in the company – an audit. It aims to determine what requirements of the standard must be supplemented. In a company where the quality system has not been functioning so far, the main and auxiliary processes are identified, their interdependencies and the basic methods of supervising these processes are determined. At the same time, the necessary documentation is created: from the quality policy and objectives, through the quality book and procedures, to the working instructions. The details of the documentation depend on the products manufactured, the processes carried out by the company and other factors, such as the size of the company or the competences of the employees. In contrast to ISO 9001, the ISO 13485 standard is much less flexible in terms of minimum documentation. Very many areas, especially those specific to the medical industry, must be defined in documented procedures. This applies to the following issues:
- Supervision of documents and records
- Design and development
- Production supervision
- Monitoring and measurements
- Monitoring and supervising the work environment
- Securing the product
- Supervision of an incompatible / returned product
- Overseeing the product with a limited time or requiring special conditions
- Software validation
- Validation of sterilization
- Feedback system
- Advisory notes
- Incident reporting
- Internal audits
- Collection and analysis of data
- Corrective and preventive actions
ISO 9001/ISO 13485
supervision over documentation,
production of the product,
The preparation of documentation is only part of the implementation of the system – the goal is to ensure that the adopted arrangements will be implemented in practice. In order to check whether such compliance is ensured, internal audits are carried out. Important sources of information are records – all kinds of documents created as part of the current activity, eg series reports, research reports, etc.
The implementation of the system can be considered completed after corrective actions were taken from non-conformities revealed during audits.
Wójcik Design considers the preparation for certification only completed after the notified body has been granted the certificate. Our company offers comprehensive service in the implementation of ISO 13485 systems, including planning, documenting and verification of the quality system. An important part of the implementation is also training for employees.
The ISO 13485 standard is dedicated to manufacturers of medical devices wishing to demonstrate the compliance of a medical device with EU legislation – it is harmonized with EU directives:
- 90/385 / EEC concerning active medical implants,,
- 93/42 / EEC concerning medical devices,
- 98/79 / EC concerning in vitro diagnostic medical devices.
A The above directives were introduced into Polish law by the Act of 12 May 2010 on medical devices and several executive regulations to the Act in the form of regulations of the Minister of Health. The ISO 13485: 2003 standard can also be the basis for the certification process of the management system. It should be noted that the last edition of the standard, PN-EN ISO 13485: 2012, contains information annexes ZA, ZB and ZC, which provide tables for correlation requirements for quality assurance systems of EU directives (above) with ISO 13485. The certificate of conformity applies to medical devices in which the notified body has participated in the conformity assessment and confirms that the product fulfills the essential requirements pertaining to it. The certificate is issued by a notified body and must contain:
- The name and number of the notified body.
- Certificate identification number.
- The name and address of the manufacturer.
- Data necessary to identify the approved product or project.
- Defining the conformity assessment procedure.
- Conclusions on conformity assessment.
- Terms of validity and date of issue of the certificate.
- Stamp and signature of the person authorized to sign the certificate.
The CE mark /equipments shall be affixed to the medical device after appropriate conformity assessment procedures have been carried out for it with the essential requirements. In the case of class I products, the manufacturer independently performs conformity assessment, i.e. it marks the CE marking and draws up a declaration of conformity. For the purpose of CE marking of a sterile class I product, devices with a measuring function, Class IIa medical devices, Class IIb, Class III, in vitro diagnostic devices included in List A, List B and intended for self-testing, the manufacturer shall carry out conformity assessment with the notified body . If the conformity assessment has been carried out with the participation of a notified body, the identification number of that body shall be affixed next to the CE mark.
A medical device (on the Polish market) must therefore have markings and instructions for use in Polish or they must be expressed by means of harmonized symbols or recognizable codes. Products supplied to service providers, with their written consent, may have markings or instructions for use in English (this does not apply to information intended for the patient).
Before the first placing on the market in the EU, through the Polish market, a medical device must be reported to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – within 14 days.
To summarize the above information, Wójcik Design will professionally carry out the certification of a medical device on the Polish market in the following stages:
- classification of the medical device,
- conformity assessment (Directive 93/42 EEC, Medical Devices Act, standards harmonized with Directive 93/42 / EEC – defining how to meet the requirements for elements of the quality management system, risk analysis, electrical safety of products or validation of critical processes. EN ISO 13485: 2012, PN-EN ISO 14971: 2012, IEC 62366),
- audit (preparation of technical documentation of the product, ie product classification document, checklist of essential requirements, flowchart and short description of the product (if your product contains software or software), risk management + report on usability engineering, document “intended use”, Clinical evaluation (literature) or results of clinical trials (class III), biocompatibility report (if applicable), electrical safety report (test results according to EN 60601-1), electromagnetic compatibility report (test results according to EN 60601-1- 2), software validation report (if the product contains software), sterilization process validation report (if your product is sterile), instructions for use, product marking (eg nameplate), test report of measurement functions (if the product meets the definition of a medical device with the function measurement), QMS documentation if it is an elek medical device),
Benefits from the certification of a medical devicehat a company cooperating with Wójcik Design will achieve:
- demonstration by the manufacturer of the compliance of the medical device with legal provisions regarding the requirements of the quality assurance system,
- increase of trust in the producer and improvement of its image on the demanding market of medical devices, better contact of the manufacturer with users of products
- ensuring the appropriate quality and safety of using medical devices,
- better cooperation of the producer with notified bodies in the area of conformity assessment of a medical device for the purpose of issuing EC certificates,
- better cooperation with national and EU institutions supervising the market of medical devices,
- restige on the market of medical devices.