Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

EU MDR

Home
Blog Standard
Tag: EU MDR
Page 2
12Jul 2024
EU MDR, General Information Cubicdesignz

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
Read More
12Jul 2024
EU, Regulations Cubicdesignz

Annex XVI – EU MDR

What is an Annex XVI product? Annex XVI products are those for which a manufacturer claims only an aesthetic or another non-medical purpose but are like medical devices in terms of functioning and risk profile. These categories of products were added in the new Regulation to establish production and surveillance standards for these previously unregulated products to protect users’ health and safety. LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) When...
Read More
12Jul 2024
EU, Regulations Cubicdesignz

Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for previously CE marked devices or for research medical devices. Clinical Investigation is governed by a clinical investigation plan with an objective, methodology, and record keeping. Top 5 Steps involved in Clinical Investigation Step 1 Appointment of a Representative- Appoint a legal representative....
Read More
12Jul 2024
EU, General Information Cubicdesignz

Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment

Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It encompasses single-use plastic items outlined in the Annex and products made from oxo-degradable plastic and plastic-containing fishing gear. Member States are mandated to implement measures to significantly reduce the consumption of singl...
Read More
12Jul 2024
EU, General Information Cubicdesignz

Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety

The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety. Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues...
Read More
12Jul 2024
EU, EU MDR Cubicdesignz

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements. Top 7 Key Strategies for optimizing Post-Market Surveillance Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR sta...
Read More
12Jul 2024
EU, EU MDR Cubicdesignz

EU Notified Body

A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.   A conformity assessment body (CAB) or a notified body is responsible for carrying out the conformity assessment procedure mentioned in the applicable Regulation. What does a notified body do? A notified body assesses whether the product conforms to the require...
Read More
12Jul 2024
EU, Regulations admin

EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
Read More

Enquiry Now

    This will close in 0 seconds