EUROPEAN UNION & REST OF THE WORLD

The new regulations MDR-2017/745 has been published in the Official Journal of the European Union went into effect in May 26, 2017 and will be finally enforced starting May 26, 2021. The new regulations replace the Medical Device Directives (93/42/EEC) and the Active Implantable Devices Directive (90/385/EEC).  The overall objective of the new MDR has been to increase the level of the human protection of human health and safety by enhancing transparency for medical devices manufactured or imported to the EU. MDR regulations introduces the following changes:

● Annex 1, General Safety and Performance Requirements have been expanded to include new requirements

● Medical device definition has been broadened to include non-medical and cosmetic devices that do not have a medical intended use

● Manufacturers will have to perform clinical investigations if they do not have sufficient clinical data to demonstrate safety and performance of their device

● Data from equivalence device is accepted for Clinical Evaluation reports, but more stringent data is needed to demonstrate equivalency

● Notified Body will play a major role in supervising the manufacturers Post Market Surveillance. PMS report needs to be produced depending on the product class and period safety update report  (PSUR)

● Manufacturers and authorized representatives should have at least one person responsible for the regulatory compliance. Small companies can reach out to out side consultants for regulatory compliance

● Under the new MDD, Eudamed database will contain the Unique Device Identification (UDI), comprehensive data on the device, notified body information, clinical investigation information as well as vigilance and post market surveillance

We at Medical Device Advice have the expertise and knowledge to help you transition with ease to the new Medical Device Regulations, MDR 2017/745. 

In 2007, an amendment was made to the Medical Device Directive 93/42/EEC (Annex X) , which required every medical device regardless of the classification to have a Clinical Evaluation Report.  This went into effect in 2010. Up until then only high risk medical devices required a clinical evaluation report. A guidance document MEDDEV 2.7/1 Rev 4 was issued by the European Commission to provide assistance to the manufacturers to comply with this regulations. 

Now with the New Medical Devices Regulation (EU) 2017/745 (MDR) coming into effect  conformity assessment to Article 61, requires confirmation of conformity with relevant general safety and performance requirements set out in Annex 1, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio, referred in Section 1 and Section 8 of Annex I. 

Clinical evaluation is a systematic and planned process to continuously collect, appraise and analyze clinical data  relevant to a medical device and to determine whether there is sufficient clinical evidence to confirm compliance to the general safety and performance requirements when using the device in according to the manufacturer's Instructions for Use. 

Clinical Evaluation is first performed during the development of a medical device and conducted throughout the life cycle of a medical device.  Each manufacturer should define and justify the frequency at which the clinical evaluation needs to be updated. When there is new post market surveillance data that has relevant data to change the current evaluation then the evaluation report must be updated. If no such information is received, the evaluation report must be revised annually for high risk devices and every 2 to 5 years for low risk devices. 

There are five stages to performing clinical evaluation reports:

Stage 0 – Defining the scope and planning of the clinical evaluation

Stage 1- Identification of pertinent data

Stage 2-Appraisal of pertinent data

Stage 3-Analysis of the clinical data

Stage 4-Finalize the clinical evaluation report

Benefit and risk of the device needs to be evaluated and acceptance of the Benefit/Risk according to the current knowledge/the state of the art in the medical fields concerned to be incorporated.

We at Medical Device Advice Inc, have extensive experience performing literature searches on various search engines (Embase, Pubmed, Cochrane, google scholar, NICE and clinicaltrials. Gov), appraising and analysing data and writing clinical evaluation reports in accordance to the MEDDEV 2.7/1 Rev 4.  Our services are very cost effective and can meet very strict deadlines. 

All CE marked products must have a technical file to show conformance to the EU Directives. The manufacturer of record is usually the person who places the product on the market and has the responsibility to develop a technical file. The manufacturer is responsible to identify the specific CE directives, requirement and conformity assessment procedures.  As a general rule, the technical documentation will cover the design, manufacture and intended operation of the product. The technical file is prepared and submitted to the notified body for a thorough review upon which the CE certificate will be issued. 

With the transition to the new Medical Device Regulations which will be enforced starting May 26th, 2020 the requirements for the technical file will be more stringent. The new EU-MDR identifies Technical File requirements in Annex II of MDR EU 2017/745.

We at Medical Device Advice have the expertise to  help you in the development of Technical files and have it ready for submission to the notified body.