What are MEDDEV documents?

MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices.

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Are MEDDEV documents still valid?

While there was only a single guidance document on clinical evaluation and investigation in 2019, the MEDDEV documents are now being replaced or supplemented more and more at this point. In 2020, seven additional documents were published to provide guidance to manufacturers.

Which MEDDEV guideline is used for clinical evaluation?

MEDDEV 2.7/1 Revision 4: Guidelines

MEDDEV 2.7/1 Revision 4: Guidelines for Clinical Evaluations
Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016.

What is technical documentation for medical devices?

A Technical Documentation is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s) and Regulations.

What are Class I II and III medical devices?

FDA Medical Device Classifications
Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What is a Class 1 medical device?

Class I Medical Devices
A Class I medical device are those devices that have a low to moderate risk to the patient and/or user. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

How often should cer be updated?

Every two to five years
Updates to your CER are required: Every year, or: When you receive new information from post-market surveillance that could change the current evaluation, or: Every two to five years if the device is not expected to carry significant risks and is well established.

Why is CER Needed?

The CER documents a device’s entire clinical evaluation process and is required to achieve regulatory compliance for marketing in the EU. Essentially, the CER outlines the assessment and the clinical data that determine if evidence sufficiently verifies the clinical safety and performance of the medical device.

What is a CER report?

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.

What should a medical device file include?

According to ISO 13485:2016, the medical device file shall contain the following:

General description of the medical device, intended use/purpose, and labelling, including any instructions for use;
specifications for product;
specifications or procedures for manufacturing, packaging, storage, handling and distribution;

What should a technical file contain?

Technical File Information

Description of the apparatus, usually accompanied by a block diagram.
Wiring and circuit diagrams.
General Arrangement drawing.
List of standards applied.
Records of risk assessments and assessments to standards.
Description of control philosophy/logic.
Datasheets for critical sub-assemblies.

Do Class 1 medical devices need a 510k?

Most Class I and Class II devices are exempt from premarket notification [510(k)] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the Quality System (QS) Regulation.

Do Class 1 devices require FDA approval?

If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA.

What are the 3 categories of medical instruments?

There are 3 classes of medical devices:

Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
Class II devices are intermediate-risk devices.
Class III devices are high-risk devices that are very important to health or sustaining life.

What is a Type 2 medical device?

Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.

What is a CER clinical evaluation report?

How do you write a CER report?

How to prepare a Clinical Evaluation Report for medical devices

General information: device and manufacturer name.
Concise physical and technical device description and intended application.
Outline of intended therapeutic or diagnostic claims.
Clinical evaluation and data types.
Summary of clinical data and review.

What is CEP and CER?

Clinical evaluation plan (CEP) Clinical evaluation report (CER) Clinical data. Literature search. Lack of clinical data.

How do you create a medical device file?

At a minimum, technical documentation should have:

A device description and specification section.
Labeling and instructions for use.
Detailed information on design and manufacturing.
Detailed risk management information in compliance with ISO 14971.

Is Bom part of DMR?

A device master record (DMR) is the compilation of all the information used to produce a device. It contains the bill of materials (all the materials used to construct a product) and the bill of operations (all the processes used to manufacture, distribute, and service the product).

Is medical device file same as technical file?

The main difference between technical files and design dossiers is that technical files (also referred to as technical documentation) are needed for all Class IIa and IIb medical devices and Class I devices, whereas the specific technical documentation for Class III medical devices is labeled as design dossiers.

What is the difference between 510k and FDA approval?

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

What is the difference between 510k and PMA?

A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.

What is the difference between class1 and Class 2 medical devices?

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls.

What is class ABCD in medical device?

Class A (low risk) Class B (low moderate risk) Class C (moderate high risk) Class D (high risk)

What are MEDDEV documents?