CE-Certificate vs. EC-Certificate
To market a medical device or IVD in the EU, a special certificate is required. But does a medical device manufacturer need a CE Certificate for sales in the European Union, or should it be an EC Certificate? This article will help you understand.
Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it
Basic UDI-DI is the identifier of a medical device within the territory of the European Union. Its presence is one of the mandatory requirements of European legislation in the field of medical devices. It emerged after the implementation of European regulations MDR 2017/745 and IVDR 2017/746.
EUDAMED registration - a brief guide
Every economic operator participating in the medical device industry in the European Union must register in EUDAMED. Registration in EUDAMED is a mandatory requirement outlined in both EU regulations governing the medical device market.
Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)
One of the important requirements of European regulations is that there must be a written agreement between the manufacturer and the Authorised Representative, officially referred to as the Authorised Representative Mandate, which European supervisory authorities may request if necessary.
GSPR – General Safety and Performance Requirements for medical devices in the European Union
GSPRs form the cornerstone of medical device regulations in the EU, setting forth the essential criteria that devices must meet to ensure their safety and performance. Adherence to these requirements is crucial for both regulatory compliance and, most importantly, safeguarding the health and well-being of patients.
How to obtain CE marking for medical software under the EU MDR or IVDR?
The essential compliance criteria are similar to those for any other medical device under the EU MDR or any in-vitro diagnostic device under the IVDR. This includes adherence to the European Union's Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for devices marketed in the EU.
Technical documentation for Medical Device Software in the EU
Technical documentation for medical device software in the EU ensures compliance with MDR and IVDR regulations. It includes essential details such as device specifications, risk management, clinical evaluation, and performance validation to support regulatory approval and safe market entry.
IEC 62304 - the pivotal standard for software medical devices
Adhering to IEC 62304 is critical for medical device software developers to ensure that their products meet safety and performance standards and pass all regulatory procedures in the European Union to ensure the market entry.
Medical Device Regulation (MDR) - basics
Compliance with the MDR is essential for manufacturers looking to market their devices in the EU. MDR is of paramount importance in the field of medical devices in the EU as it significantly elevates the standards for patient safety and product quality.
ISO and IEC standards for medical device software
These standards provide a structured framework for manufacturers to ensure that their software meets the standards of reliability, safety, and performance. The standards are important for medical device companies seeking CE-marking and market access in the European Union.
Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle
The importance of clinical evaluation extends far beyond the initial stages of device development and CE certification. It forms an inseparable link with PMCF and PMS, collectively shaping a holistic approach to ensuring the ongoing safety and effectiveness of medical devices.
Notified Bodies and their role in certification of medical devices
Notified Bodies (NBs) are private organizations designated by EU member states to assess the conformity of medical devices before they are placed on the market. They play a crucial role in the European regulatory system for medical devices.
What is NANDO and why medical device companies should know about it?
NANDO is a valuable tool within the EU's regulatory infrastructure, providing transparency, accessibility, and verification capabilities for stakeholders involved in conformity assessments, particularly those related to New Approach directives and regulations.
Labeling and UDI requirements for medical devices in the EU
The label of a medical device must include essential information such as the device's intended purpose, instructions for use, contraindications, manufacturer's details, and any precautions or warnings. The information should be clear, understandable, and in...
Understanding the roles of Authorized Representatives and Importers under MDR/IVDR
Two important actors in this regulatory landscape are Authorized Representatives (ARs) and Importers, each playing distinct yet crucial roles in ensuring compliance and safety. Authorized Representatives act as a bridge between non-EU manufacturers and EU regulatory authorities.
MDR implementation - challenges and solutions
In this article, we explore these challenges to understand the nuances that demand strategic attention and present practical solutions to address these challenges and empower manufacturers in meeting regulatory demands in the EU.
Post-market surveillance under MDR and IVDR - requirements and best practices
The MDR and IVDR have significantly elevated the expectations and obligations surrounding post-market activities. Beyond mere compliance, these regulations underscore the importance of proactively ensuring the safety, performance, and effectiveness of medical devices in real-world scenarios.
Notified Body audit - a manufacturer's guide
A Notified Body audit for a medical device may seem like a challenging task, requiring one big effort to succeed. However, there's no one big secret trick to ace it. Success is not one big leap but a series of small, consistent steps that, when taken together, pave the way for a successful certification.
Risk management plan - guide for medical device companies
MDR and IVDR state in no uncertain terms that risk management activities should be planned. Therefore, for every single medical device, the manufacturer should establish and document a Risk management plan in accordance with the manufacturer's risk management process.
Should my medical device comply with GDPR?
Generally, compliance with GDPR is necessary whenever personal data is involved in the operation, use, or processing of medical devices or IVDs to ensure the protection of individuals' privacy rights and data security. So the simple rule to determine whether or not your device must be GDPR-compliant is:
EC-certificate for a medical device - Q&A
Notified Bodies issue certificates following audits and inspections, ensuring that devices meet the safety and quality standards outlined in the two EU medical device regulations - MDR and IVDR. Only certain classes of medical devices undergo these audits and inspections and subsequently receive certification.
How long does it take to CE-mark a medical device?
Despite the complexity and variability inherent in the CE marking process for a medical device, we can attempt to outline average timelines based on industry experiences. By breaking down the process into its constituent parts and considering potential bottlenecks or delays, we aim to...
What is a PRRC?
Medical device and IVD companies operating in the EU are mandated to have a PRRC within their organization. Small and micro manufacturers may not necessarily have a PRRC within their organization but must ensure the availability of such an individual permanently and continuously.
Essential requirements for importers and distributors under MDR and IVDR
In the European Union, the roles of importers and distributors in the medical device supply chain are distinct, yet both are important in ensuring that medical devices meet regulatory requirements before reaching end-users.
Language requirements for IFUs and labels under the MDR and IVDR
The language requirements outlined in the MDR and IVDR are, at their core, clear and straightforward. Simply put, all information provided with a medical device...
Legal Manufacturer and Original Equipment Manufacturer in medical devices
In the context of medical devices, Legal Manufacturer-Original Equipment Manufacturer (LM-OEM) scheme has become a widely adopted model. It allows medical device companies to...
How to structure a PRRC contract for effective compliance
When drafting a contract for a PRRC, it’s important to clearly outline their qualifications. These qualifications should, at a minimum, meet the baseline requirements specified in Article 15.
How to Create a Declaration of Conformity According to MDR or IVDR
The Declaration of Conformity is a legally binding document that certifies your device meets EU safety, quality, and performance standards. Here’s a basic template for a DoC:
