Guide: Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) - Regulation (EU) 2017/745
It is the manufacturer's responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements under Regulation (EU) 2017/745.
This guide recalls the principles of clinical evaluation and describes the different elements to be included in:
- The clinical evaluation plan
- The clinical evaluation report
- The post-market surveillance plan including the post-market clinical follow-up (PMCF) plan
- The PMCF evaluation report
All these documents are part of the technical documentation, within the framework of CE marking procedures for medical devices, regardless of the medical device class.
Guide: Application request for CE marking certification – Regulation (EU) 2017/745
This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) 2017/745 and also details how to obtain a quote and submit a Formal Application for certification with GMED.
You will also find in this guide the different conformity assessment procedures applicable depending on the risk class, the type of device as well as their corresponding documents to be transmitted as part of your Formal Application request.
Presentation of biological evaluation according to ISO 10993-1
GMED is happy to inform you of the recently release of a Guidance Document on Biocompatibility.
The objective of the document is to help manufacturers in their efforts to present the demonstration of the control of the Biological risk according to the NF EN ISO 10993-1 Standard.
CE Marking of Medical Devices
GMED technical experts developed this valuable guide to help our clients navigate the complex regulations surrounding placing their medical devices on the European market.
This guide gives you the information you need to jump start your certification efforts and make smart decisions that could save you time and money in obtaining CE Marking...
CE Marking of In Vitro Diagnostic Medical Devices
IVDs (in vitro diagnostic devices) play an important role in the diagnosis and treatment of diseases around the world, including Europe. As with medical devices, the regulations for marketing IVDs in the European Union requires that the manufacturer follow a conformity assessment route to show that their IVD conforms to essential requirements.
However, because of the inherent differences between medical devices that fall under the MDD and IVDs, they have their own essential requirements and different classification rules and common technical specifications...
How to change your Certification Body to GMED in 8 steps
As oversight over notified bodies’ increases, a notified body maintaining its notifications and scope of qualifications becomes even more important to manufacturers whose market access lies in the balance.
GMED developed this guide to give manufacturers peace of mind when they are faced with the choice of transferring notified bodies and how it is done...
Japanese Medical Device Approval Process
As one of the largest and most affluent aging populations in the world, Japan is an ideal market for medical device manufacturers. As the Japanese population lives longer, medical device manufacturers have more opportunities to take advantage of one of the largest medical device markets in the world. Japan is well-known, however, for being exacting in its standards and regulations, especially for foreign companies and manufacturers.
GMED technical experts developed this valuable guide to help Medical device manufacturers understand the Japan medical device marketing process...
Brazilian Medical Devices Approval Process
GMED technical experts developed this valuable guide to help Medical device manufacturers understand the Brazilian medical device marketing process. The Guide covers all the major medical device regulations in Brazil and outlines the process that manufacturers take to register and market their device...
Unannounced audits for manufacturers of CE-marked Medical Devices
Systematic unannounced audits are required after Recommendation 473/2013/EU, which prompted many questions from manufacturers about performing the audits, the scope, requirements, and other points.
In response, GMED created a clear Frequently Asked Questions guide that explains everything about unannounced audits including how the manufacturer will know, product sampling, and other points...
Define a Testing Strategy
This guide is a document aiming to advise medical devices manufacturers/importers about the preclinical technical evaluation of their devices.
The approach suggested helps set up a strategy as regards the tests required for the technical
evaluation of a medical device through a non-exhaustive list of questions.
The testing strategy should be defined with the laboratory that will perform the tests. Its expertise and
experience will contribute to structuring your thoughts by asking the right questions.
Implementing EN 60601 3rd Edition
The Guide outlines the major principles of the IEC 60601 3rd edition series of standards and points out some major factors manufacturers can use for success with the 3rd edition. Additionally, GMEDprovides solid answers to the most important questions, lighting the way through the 3rd edition for manufacturers...
Electromagnetic Compatibility Guide (EMC) for Medical Devices
Electromagnetic compatibility is an important and integral part of the characteristics of an electrical medical device. In fact, a device could be vulnerable to electromagnetic waves emitted by a wide variety of electrical objects placed in the environment of the medical device. This is a major issue for some devices, especially life-saving devices where the patient’s life depends on the electrical medical device working properly. Let GMED’s Guide to Electromagnetic Compatibility light the way to your electrical medical device’s CE marking...