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This document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations to ensure compliance to ISO 10993-1.
This is a general template for all classifications which can be adopted to suit your needs. The CE tech file template also includes the General Safety and Performance Requirements Annex I in a tabulated format.
A preview of the CE Technical File is available here:
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All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.
This document was designed to provide guidance to manufacturers of medical devices to help them understand the requirements for clinical evaluation and investigation of their product(s) under the new EU Medical Device Regulation 2017/745.
A preview of the Clinical Evaluation Guidance Document is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.
A preview of the Clinical Evaluation Template is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This document illustrates the relationship between the economic operators and addresses the responsibilities of each one.
A preview of the Economic Operators Gap Assessment is available here:
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This document will help you understand whether your products falls under the definition of systems and procedure packs as per the 1993 Medical Device Directive (MDD) and the new 2017 Medical Device Regulation (MDR), how to classify your product and which actions to take to get on track for compliance with new MDR requirements.
A preview of the Guidance for EU MDR – Systems and Procedure Packs is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The new European medical device regulation, EU MDR 2017/745 has seen the introduction of a new subclass of Class I devices covering reusable surgical devices and the reprocessing of single-use devices for sale on the European market.
This guidance document aims at helping manufacturers determine the classification of their device; provide a reference to the broader MDR; understand the requirements of their device regarding conformity and the documentation supplied with the device.
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You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This guidance document is aimed at helping manufacturers of medical device products that are designed to be used in combination with substances that are considered pharmaceutical drugs or medicinal products (Drug-Device combination prodcuts), understand whether their product(s) will be regulated as a drug or regulated as a device, the classification and relevant regulations that apply to their products(s) and the implications of the new EU Medical Device Regulation 2017/745 on existing and new drug-device combination products.
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This document will help you understand the definition of SaMD under the 1993 Medical Device Directive as well as the 2017 Medical Device Regulation, how to classify your software and which conformity route to take in order to become complaint with the new MDR.
A preview of the Guidance for EU MDR Software as a Medical Device (SaMD) is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.