Notified bodies medical devices examples
Notified bodies medical devices examples. Technical Documentation assessed by the Notified Body. Examples of active medical devices are pacemakers and insulin pumps. Manufacturers must always prepare the technical documentation for their medical device and submit it to the notified bodies (except for class I devices). 05. Class I Certification for Sterile and Metrologic Devices: Prepare a CE marking Technical File Oct 3, 2022 · The MDCG’s latest publication both recognizes and attempts to assuage these concerns by proposing counter-actions aimed to “enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices”. CHICAGO: +1(630) 270-2921 NEW YORK: +1(516) 829-0167 2. May 7, 2024 · The European Commission published a guide on the classification rules, which includes examples of products related to each rule. For some high-risk devices, NBs assess their conformity to the requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Nov 13, 2023 · One of the recommendations accepted by the Australian Government from the Expert Panel Review of Medicines and Medical Devices Regulation (the Review) was a better utilisation of marketing approvals of medical devices, including IVD medical devices, where the device has been: submitted to the Notified Bodies and regulators, and the decentralised nature of approval decisions. doc The purpose of this Recommendation is to provide guidance to Notified Bodies, Oct 15, 2023 · The decision-making criteria behind MDCG 2020-3 and MDCG 2022-6 are easy to understand and will not come as a surprise to medical device manufacturers who were already familiar with the old guidance from Notified Bodies, NBOG BPG 2014-3, or with similar guiding principles published in other jurisdictions, e. This amendment created the risk-based classification system of Dec 13, 2021 · As of today, DNV is accepting MDR applications but the timelines are now 8–10 weeks to start a project for most medical device categories. Notified bodies must, without delay, and at the latest within 15 days, inform the Aug 14, 2024 · All MDR Notified bodies are not designated to be able to perform conformity assessments for medical devices. • For Class III devices a Notified Body evaluates the design of the medical device, by reviewing a design dossier submitted by the manufacturer, and issues a certificate Quality Systems of Medical Device Manufacturers“, section Special audits (MedDev 2. 1. 33(4) (Independence) 33(9) (professional integrity) and 33 (10) (sufficient internal competence of personnel in AI) and all this should have been assessed when the Notified Body got the designation under the MDR. 1/Rec5 Title: Technical Documentation Page 2/21 vdtuev-document dn: \hoeppner\mp\nb\rec_vdt2\R2_5_1-5_rev4. The full list of notified bodies based in Ireland and the associated Directives/Regulations may be found on the European Commission website. 3) SMEs are more impacted by the MDR than larger companies. Notified bodies shall conduct surveillance on site audit at least on an annual basis as well as unannounced audit of manufacturer and where applicable subcontractors and suppliers. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. This will have a significant impact on healthcare systems. 12,13. Dimension 4: Software maturity level CE mark example Authorized Representatives. For IRBs, Clinical Investigators, and Sponsors. The members are Notified Bodies under any or all of the three medical device directives: 90/385/EEC; 93/42/EEC; 98/79/EC. • For Class III devices a Notified Body evaluates the design of the medical device, by reviewing the technical documentation submitted by the manufacturer, and issues a Information Sheet Guidance . For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. Under the new regulation, the Notified Bodies themselves have to meet stricter demands. In this context, it is considered that alternative solutions to carrying out on-site audits by notified bodies under the medical devices Directives1 should be allowed under specific circumstances, Team-NB is the European Association of Notified Bodies active in the Medical device sector. In this article, we will explore the definition It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market. Transition Summary. Market surveillance (ICSMS) Information and Communication System for Market Surveillance (ICSMS) is the comprehensive communication platform for market surveillance on non-food products and for mutual recognition for goods. To assist the current discussions of legislative and . According to European legislation, the involvement of a Notified Body in the conformity assessment procedure depends on the type of product and the European harmonized standards which have to be met in each particular case. • IVDs are now classified into four risk classes that will require Notified Body review for about 90% of the devices, up from the current 10% HOW WILL THESE CHANGES BE IMPLEMENTED? • Medical device companies have until 2020 to fully implement these changes. For example, in the case of medical devices which present risk factors, certification by a Notified Body is required. Dec 31, 2020 · Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) UK Approved Bodies. Article 50 of the Regulation requires Notified Bodies to publish a list of fees associated with certifications and follow-ups, MDCG 2022-14 position paper emphasizes this obligation and invites NBs to adapt their costs to company sizes. g. You can expect that if you are going through a Notified Body, they will definitely review your file. Step 3: The Class B notified medical device manufacturer needs to fill the form MD-3, and the importer needs to fill out form MD-14. Jun 27, 2023 · The Danish Medicines Agency ensures that its control is updated in line with developments in the medical devices area in the EU through participation in the EU authorities’ working group in the field of notified bodies under the medical devices legislation. Jul 1, 2023 · From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory Classifications of Medical Devices Under MDR Class I medical devices will require involvement of a Notified Body if they are sterile, have a measuring function or are re-usable surgical instruments. The Notified Body should also review those changes considered by the manufacturer 1. For devices other than those subject to self Jan 12, 2024 · A notified body must approve medical devices before they can be marketed and sold in the European Economic Area (EEA) unless they are for research purposes or Class I non-sterile, non-reusable surgical instruments, and without measuring function devices. Nonetheless, the notified body needs to ensure that the assigned staff is qualified to assess all components of the device. If the requirements are being fulfilled, the Jul 26, 2018 · Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). The information can be filtered by legislation to identify: List of notified bodies under Regulation (EU) 2017/745 on medical devices. These bodies carry out conformity assessment procedures for all devices classified outside the lowest risk classification. Audits performed by notified bodies happen in two ways. Both these things save time and money. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market. A Notified Body (NB) is a conformity assessment body designated under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746) that assesses the conformity of medical devices for CE marking before they enter the European market. Examples of medical devices with an ancillary medicinal substance include: drug-eluting stents; bone cement containing an antibiotic; Nando (New Approach Notified and Designated Organisations) Information System; NANDO - Notified Bodies for active implantable medical devices (90/385/EEC) Notified Bodies for medical devices (93/42/EEC) Notified Bodies for medical devices (MDR) Notified Bodies for in vitro diagnostic medical devices (98/79/EC) Dec 14, 2020 · The European Commission published a list of recognized notified bodies that perform assessment tests on products like toys, electronics, medical devices, and more. Jun 2, 2021 · In Europe, the agencies involved in these assessments include the EMA, the national competent authorities for the medicinal product part and the Notified Bodies for the device part. Aug 14, 2024 · Class 2a Medical Device constitute medium-risk devices such as orthodontic wires, surgical gloves, lancets, etc. New obligations apply for economic operators that include post-market surveillance for devices they place on the market. They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market. The only valid “voluntary certification” is in areas where legislation provides that a certificate is not mandatory, but still only duly notified bodies technological principle of the device should be considered (Example 3). Further detailed examples may be found in the Manual on Borderline and Classification in the Community Regulatory framework for medical devices, published on the European Commission website1. Based on this documentation, the auditor will assess For class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, the notified body must also follow the clinical evaluation consultation procedure where certain documentation including the clinical evaluation report is submitted for review A manufacturer is only allowed to market a medical device in Europe if it fulfils certain legal requirements. Apr 27, 2023 · In vitro diagnostic devices of risk class A sterile, B, C and D. This Technical Documentation submission guidance is aligned to the requirements of (EU) 2017/745 Medical Devices Regulation (MDR), described in detail in Annexes II and III of (EU) 2017/745. According to EU directive 2017/745 and 2017/746, it is a legal requirement to appoint a European Authorized Representative (EU Rep) for a medical device manufacturer who does not have a registered place of business in a particular EU Member State. Jan 24, 2024 · For example, if a body is notified for machinery, it should not issue certificates (“voluntary” or other) for products that are not machinery (such as personal protective equipment). Our Expertise. The This section outlines the criteria for affixing a UKNI marking to devices should any UK Notified Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB-MED/2. Notified body guidance documents fall into one of three categories: those published by notified bodies themselves (NB-MED), those adopted by the European Commission as official guidance documents: “MEDDEV” for Directives on medical devices and MDCG guidance documents for Regulations on medical devices, and Document: Link: Notified Bodies : Notified Bodies according to § 15 Medical Devices Act : In accordance with § 15 (4) of the German Medical Devices Act current information on the scope of designations as well as the identification numbers of German Notified Bodies in the ar BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. Aug 13, 2023 · In the following, we describe when the notified body must also be involved. Oct 1, 2020 · The following offers an overview of all current Notified Bodies listed in the online database which are already MDR certified. Mar 2009 NBOG BPG 2009-2: Role of Notified Bodies in the Medical Device Vigilance System Sep 12, 2022 · [article originally published on June 10, 2021] Comparison of Notified Body (NB) fees for the Medical Devices Regulation. The Association of Notified Bodies (Team NB) has published a recommendation in NB-MED/2. A Notified Body is an organization designated by the EU Commission to assess the conformity of medical devices before being placed on the market. For class 2a the declaration of conformity is backed up by notified body assessment post submission of technical documentation file. classification for reusable surgical devices requiring notified body oversight. 2/Rec2, which is intended to provide more clarity on the communication of design changes to the respective notified body. It establishes a risk-based classification system for these devices, enhancing regulatory scrutiny with most devices requiring a conformity assessment by a Notified Body. Medical devices that meet the legal standards are given a CE certificate. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under Apr 27, 2023 · 1. Medical device companies must choose from this list of accredited notified body firms as part of the conformity process. Jul 2, 2013 · A report from the European Medical Devices Expert Group, “Report on the Functioning of the Medical Devices Directive” (2002), 2 describes generally accepted concerns regarding the competence of Notified Bodies to perform the tasks for which they are designated, differences in interpretation between Notified Bodies and lack of transparency Nov 8, 2021 · The European Commission publishes a list of recognized notified bodies that can legally perform conformity assessment audits on medical devices. Article 35: Authorities responsible for notified bodies. Jan 17, 2023 · Notified bodies have the option to start with the example of a very limited class of devices, e. Without such a certificate, a producer is not allowed to market a device. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. Feb 8, 2022 · Reusable devices, such as surgical tools not attached to an active medical device, also need Notified Body certification. Class IIa medical devices are considered medium-risk devices by the MDR. This guidance represents the Food and Drug Administration's (FDA's Aug 27, 2023 · A Notified Body (NB) is a conformity assessment body designated under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746) that assesses the conformity of medical devices for CE marking before they enter the European Oct 7, 2022 · Since October 2018, comparable overseas regulators and assessment bodies include: Notified bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union; the Food and Drug Administration of the United States; Health Canada Class IIa Medical Devices require, Product testing, Quality system implementation (ISO 13485) Techinical file preparation, Notified Body audit and Certification. When a Notified Body looks at your QMS structure, they’ll want to see that you’re following the MDR requirements. Class IIa Medical Devices. The present guideline provides non-exhaustive lists of examples of IVD medical devices, accessories to IVD medical devices and medical devices. Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment Note: Please note that the current scope expressions (MD / MDS codes) can be found in the respective notification forms below. Digital Trust. To view the guide, enter into the European Commission’s site containing guidance documents concerning the Medical Devices Regulation and search for the document entitled “Guidance on classification of medical devices”. Feb 21, 2023 · During a recent ISO 13485 Certification Audit the Auditee, a supplier of moulded parts for a medical device manufacturer, was very surprised to discover that her premises could be subject to Unannounced Audits by a Notified Body. EU Regulations, EN Standards, Notified Body activities (including Surprise/Unannounced Audits), UK Regulations post-Brexit, MDSAP – all are changes that will impact your company’s Medical Device Management System (MDMS). These devices undergo rigorous classification and regulation processes to ensure their safety and effectiveness. Class III medical devices are a crucial part of the healthcare industry, as they are designed to support or sustain human life, prevent potential risks to health, or have a substantial impact on the structure or function of the body. May 21, 2024 · A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. Step 2: Classify the medical device based on the risk. Mar 5, 2024 · No matter what classification your device is or which pathway you are taking, a technical file is necessary. • For Class III devices a Notified Body evaluates the design of the medical device, by reviewing a design dossier submitted by the manufacturer, and issues a certificate A designated body (Swiss term) is the same as a notified body (EU term). What suppliers to the Medical Device Sector need to know. the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Harmonised and International standards: - EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice Information about bodies including their contact and notification details can be found in section Notified bodies. The technical documentation is also subject to ISO 13485 audits. In 1976 with the Medical Device Amendments to the Food, Drug and Cosmetic Act (FD&C Act) [4], medical devices were regulated for the first time in the United States. allow continued availability of safe medical devices to the market and assist in the prevention of the risk of medical device shortages. The following video explains them in-depth, and it is a part of our online course Introduction to the Medical Device Regulation (MDR) 2017/745 . The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. In 2019 the EMA Mar 8, 2024 · There will be a three year transition period for the Notified Bodies to upgrade their systems, obtain the relevant expertise and extend the certification of devices under the sectoral law, e. May 1, 2024 · Class Ir: The medical device is a reusable surgical instrument. 2021) internal Link: List of Notified Bodies – Directive 98/79/EC on in vitro diagnostic medical devices (status as of 25. List of notified bodies under Regulation (EU) 2017/746 on in vitro diagnostic medical devices. regulatory reforms intended to regulate AI/ML-based medical devices, we aimed to identify and analyse AI/ML-based medical devices approved in the USA and. But many notified bodies are not even accepting MDR applications for certain medical device categories or generic device groups, causing manufacturers to embrace new project timelines that are approaching Feb 4, 2022 · The Medical Device Regulation codes, or MDR codes for short, specify what the notified bodies are designated for and thereby stipulate what category of devices the notified bodies can work with. In addition, for class 1 medical devices, the MDR does not insist on the certification of the quality management system by a notified body. 5. ** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. In addition, the documentation must include a clinical evaluation. 5/2, latest revision)) The Notified Body should review during audit the operation of the manufacturers system to classify changes as “substantial“ and to inform the Notified Body. , only with software as a medical device or only with reusable surgical instruments. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The authorization of medical devices is guaranteed by a Declaration of Conformity. What is a Notified Body for Medical Device Development? A notified body is a private organization designated by an EU country to assess the conformity of certain products before being placed on the market. The Commission has published its Blue Guide which provides an overview of the product regulatory system within the European Union. Designated bodies verify medical devices’ compliance with legal requirements. Instead, some Notified Bodies will be designated to do conformity assessment of other items such as toys, communication devices or construction products that have other regulation/directive. This list will be updated on an ongoing basis as more Notified Bodies are approved for the EU MDR. 1 Frequently Asked Questions About Medical Devices . Example 3: A medical devices is composed of a suture anchor (a bone screw attached to a Oct 30, 2023 · SaMD may be used in combination (e. When asked what she would do if such an Audit Team came to the door, she said that they would be asked to leave. There it is checked for the first time. Low risk Increasing risk Class III Class IIb Class IIa Self-assessment Class I Examples: Medical gloves Masks Wheelchairs Stethoscopes Spectacles What is a notified body? NBs assess the conformity of products to applicable requirements before manufacturers place them on the EU market. Jun 24, 2024 · Medical devices of classes Is, Im, Ir, IIa, IIb, and III must be subject to a conformity assessment procedure by a notified body. The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. This means that unlike a Class I device, the manufacturer must receive a declaration of conformity from a notified body following its conformity assessment. May 26, 2021 · Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. doc The purpose of this Recommendation is to provide guidance to Notified Bodies, Mar 3, 2023 · A notified body does not have to be involved in the conformity assessment procedure for class 1 medical devices. These products fall under the medical devices legislation and must be CE marked. For the purposes of these Regulations, the HPRA is the authority responsible List of Notified Bodies – Directive 93/42/EEC on medical devices (status as of 25. 24 Under the new legislation, notified bodies May 10, 2011 · The more precise commitments on the service level of a notified body will benefit the medical devices industry and in the end the end users and patients, especially if courts are willing to have resort to these in case of disputes between non-signatory notified bodies and their clients, as well as member states that may make observance of the Role of Notified Bodies in the Medical Device Vigilance System 1 Introduction The medical devices Directives require manufacturers to report incidents involving their products that result in the death or serious harm of a patient or user or which have the potential to cause death or a serious deterioration in his state of health. SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software. . It is difficult to know which categories of medical device would be left unaffected by MDR implementation. Feb 5, 2024 · This guide lists notified bodies for medical devices in the EU, explain what types of medical devices require a notified body, and more The Commission publishes a list of designated notified bodies in the NANDO information system. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. medical devices and in-vitro medical devices. In all EU-countries, so-called Notified Bodies assess medical devices and their compliance with regulations. The term medical devices also includes in vitro diagnostics. Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2. Clearer requirements for clinical data on medical devices and its assessment. Our Expertise; Shaping society by developing a resilient digital future, that respects privacy, safety, cybersecurity, and reliability. The EU MDR states that medical device manufacturers must: Prepare technical documentation before placing a product on the market. • Up to 30% of SMEs have either no Notified Body (15%) and/or have a Notified Body that is not yet designated to MDR Oct 1, 2023 · The responsibility for approving medical devices and monitoring in the post-market phase lies with Notified Bodies. More specific product requirements; Improved pre-market assessment of high risk devices Jan 22, 2024 · The active nature and potential impact on bodily systems necessitate increased regulatory oversight, often placing them in Class IIb or Class III medical devices. • Article 43(3) AIA says that Medical Devices Notified Bodies can control the AI conformity assessment as long as they comply with art. Team NB guidance document. We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. Mobile apps that meet the definition above are considered SaMD. Furthermore, the duration of use is also considered when classifying medical devices, as follows. Here, we cover all the most important information for MedTech innovators and manufacturers to understand the role of Notified Bodies in medical device development and how to select the correct one. The Commission assigns a 4-digit code to each Notified Body, with the purpose of uniquely identifying each company that acts as a Notified Body. For instance, a class IIa device can receive a certificate valid for just three years. Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB-MED/2. Jan 13, 2021 · Note: Ultrasound devices will then likely require Import Licenses beginning November 1 st, 2021. 1 The Active Implantable Medical Devices Directive (90/385/EEC), the Medical Devices Directive (93/42/EEC) and the in-vitro Diagnostic Medical Devices Directive (98/79/EC) all provide for the appointment of independent certification bodies called Notified Bodies (NBs). Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices”. , as a module) with other products including medical devices. The 4th indent of the definition of a medical device specifies “providing information by means of in vitro examination of specimens derived from the human body […]” as a medical purpose and thus refers to in vitro diagnostics (IVDs), which are a subgroup of medical devices. Medical Devices Notified Body BSI (BSI-UK / BSI-NL) and medical device manufacturers both have an Improved performance of notified bodies* for medical devices. A clinical evaluation is an ongoing process in which clinical data from various relevant sources, for example scientific journals and own clinical investigations or performance studies (for IVDs), are analysed and assessed to fully document that the device complies with general safety and performance requirements. risk) devices, a Notified Body audits the manufacturer’s quality system and the manufacturer requires a favourable audit to proceed to CE marking. Dec 22, 2022 · CE marking validity will be determined by the Notified Body and depends on the medical device classification, but it cannot exceed five years. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified Body. Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). After that, the device needs to be re-certificated. Guidance on the preparation of a curriculum vitae for a Medical Device Expert; example of a form Example of a training course format The responsibilities of the Notified Body under the Medical Device Directives Document Special Rules of accreditation for Certification Bodies of Quality Systems (scope “Sterile Medical Devices”) May 1, 2023 · Step 1: Check if your device classifies as a notified medical device mentioned by CDSCO. Mar 23, 2023 · The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices. Main menu; Where we see the biggest opportunities and challenges facing organizations across the world. Mar 8, 2024 · According to the definition of a medical device, every medical device must have a “specific medical purpose“. 2022) internal Link: List of identification numbers of Notified Bodies under § 15 Medical Devices Act: PDF Feb 1, 2024 · Notified Body expectations of device manufacturers. During an audit, the Notified Body will look closely at how you’re addressing the general obligations of device manufacturers under Article 10 of MDR. US FDA’s when to submit a new Jan 21, 2022 · A notified body (also referred to as a UK-approved body in the UK) (defined in Table 1) assesses whether medical devices meet the legal requirements. Notified Bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is medical devices Directives when making designation applications to the HPRA under article 38 of Regulation (EU) 2017/745 on medical devices1 (hereafter MDR) and corresponding articles in Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices2 (hereafter IVDR). Depending on the risks associated with a medical device, an independent notified body has to be involved to check and/or test whether these legal requirements are fulfilled. filme mlqovcy pebc coflkt bqralh mzqzgx pct ymdty rdsua kez