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News October 24, 2024 Cubicdesignz

MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers 

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body tha...
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18Oct 2024
EU, Regulations, Swiss, UK, USA Cubicdesignz

Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance (SSCP) acts as a vital document that allows the public to access information quickly. The information in the SSCP can be sourced entirely from the technical file. The technical file consists of the Post Market Surveillance (PMS), risk assessment, post-market clinical follow-up (PMCF) plans and reports. The SSCP document is required for high-risk devices only-this includes Class III and all implantable devices. Manufacturers of custom-made or investigati...
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18Oct 2024
EU, Regulations, UK Cubicdesignz

7 SaMD Device Regulation (UK & Europe)

Under both the EU MDR and the EU IVDR, the MDCG rules specify the conditions for a product to qualify as medical device software (MDSW). An MDSW product can enter the market in one of the ways:   1. As a standalone medical device or   2. As a component of another medical device regulation.  The former demands a lengthy regulatory process that includes a conformity assessment to determine whether the medical device meets EU MDR requirements. However, that rule does not apply to products in...
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18Oct 2024
EU, General Information, Regulations, UK Cubicdesignz

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...
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17Oct 2024
Registrations Cubicdesignz

Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes

MoH  The Ministry of Health and Social Protection. MoH Website https://shendetesia.gov.al Regulatory Authority National Agency for Medicines and Medical Devices (AKPBM) Link for Regulatory Authority https://akbpm.gov.al/ Medicine/Drug/OTC/Pharmaceutical Registration in Albania The Agency for Medicinal Products and Medical Devices (AMPMD) is responsible for overseeing the drug registration process in Albania. Here is a general outline of the drug registration process: 1. Preparation of Documenta...
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17Oct 2024
Registrations Cubicdesignz

Streamlining the Afghanistan Drug Registration: A Comprehensive Guide for Approval and Compliance

MoH Ministry of Public Health MoH Website https://moph.gov.af/en Regulatory Authority Afghanistan Food and Drug Authority National Medicine and Health Products Regulatory Authority (NMHRA) Link for Regulatory Authority https://afda.gov.af/index.php/en/market-0 Afghanistan Drug Registration Procedure Pre-Market Afghanistan Drug Registration Procedure In the ever-changing healthcare landscape of Afghanistan, it is critical to effectively regulate medical goods and services. This paper explores the...
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17Oct 2024
EU, EU MDR, Registrations Cubicdesignz

MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.  This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...
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16Oct 2024
EU, Registrations, Regulations Cubicdesignz

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II 1. Device description and specification, including varia...
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16Oct 2024
Registrations Cubicdesignz

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....
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16Oct 2024
Registrations Cubicdesignz

Medical Device Registration in Romania

Ministry of Health     Ministry of Health Regulatory Authority      National Agency for Medicines and Medical Devices of Romania (NAMMD) Medical Device Regulation          EU MDR 2017/745 EU IVDR 2017/746 Official Language     Romanian Classification of Medical Devices  Class I, IIa, IIb and III Registration Process 1. Determine the device classification 2. Appoint an Authorized Representative and Notified Body 3. The medical devices must be registered in the NAMMD da...
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