As a medical device legal manufacturer, you are solely responsible for maintaining compliance with the applicable EU Directives and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.
CE Mark Composition
Obtaining a CE mark requires two items: certification of the quality system to ISO 13485 and review of the Technical File. The quality system is primarily concerned with design and manufacturing controls and requires the development of standard operating procedures (SOP's). During the certification process, the Notified Body (NB) will review compliance of the company’s operations to the SOP's. Some of the key topics covered in a quality system include personnel training, product traceability, specification development, manufacturing controls and risk management. The Technical File establishes the standards that must be met regarding the safety and performance of a device and summarizes the information that shows how the device meets those requirements. Some of the typical information included in a technical file includes biocompatibility, sterilization and product performance. Two key elements includes a summary of Risk Management as defined in ISO 14971 and a clinical evaluation report based either on a literature review or obtained/collected clinical data by the company during their clinical trials.
Device Classification in the EU Process and Impact on the CE mark
In Europe are four classes of medical devices: I (Is - Im), IIa, IIb, III. The description of the intended use, or defined medical claim, determines the risk classification of the device. This is important because a Notified Body might agree that the company may complete a literature review rather than conducting a prospective clinical trial. If this scenario occurs, the timeline to receive a CE mark shortens considerably. Pre-strategy meetings with candidate Notified Bodies are highly recommended at an early phase to clarify the regulatory needs thus determining the overall project budget and timeline.
Less Data, Less Time
A manufacturer must prove that a device is safe and performs as described in the Instructions for Use (IFU) in order to place the CE mark on the device. Since performance can be proven rather quickly, clinical trials, when they are required by the Notified Body are generally small and not randomized. These requirements sharply contrast the clinical requirements for many devices in the United States where randomized trials of more subjects are the norm. The new Medical Device Regulations (MDR) will bring in 2016 - 2017 significant changes in the European regulatory landscape. The MDR is not published yet but the most important changes can be read on our News' items.
Shorter Timelines
Given the straightforward classification process and the focus on safety and performance, a CE mark can be usually obtained in a relatively short time. If the company has a quality system in place in line with ISO 13485 and the Technical File is complete, the timeline can range from two to three - four months after quality audit and file submission.
Leveraging EU Data in the US
If the company can get the CE mark with a small clinical trial, the data obtained may be supportive in the United States.
Often EU data can be used to support the sample size selections of a pivotal trial. In certain circumstances it may count towards the US requirements. Discussion of the role of European data in the US process should be reviewed with FDA during a pre-submission meeting or discussed in the IDE process.
When trying to leverage EU data in the US, it is very important to understand whether the site has participated in trials that have been reviewed by FDA as foreign sites are now audited frequently by FDA. You do not want your study to become the site’s learning experience.
Important Selections
Selecting the Notified Body is an important decision since the company and Notified Body must agree on the classification of the device and whether a clinical literature review is sufficient or a prospective trial is required.
Additionally, if the medical device company does not have a physical office within the European Union, an Authorized Representative with a registered office in one of the EU Member States is required. The Authorized Representative is responsible for product registrations and vigilance reporting. Full contact information of the Authorized Representative must appear on the product’s labeling and instructions for use.
Our services may include
- Assistance with product classification and identification of applicable standard for your medical devices: (AIMDD - MDD > MDR; and IVD > IVDR)
- Medical device and In Vitro Diagnostic CE Marking Technical File or Design Dossier compilation (STED) and review
- Verification of required Essential Requirements
- Implementation, modification and maintenance of a quality management system - usually ISO 13485 - that meet European and other international requirements
- Authorized Representative services in the EU
- Risk Assessment and Management (ISO 14971)
- Development of vigilance and post -market surveillance procedure - including Post Market Clinical Follow Up (PMCF)
- QP Services - synonym of 'person responsible for regulatory requirements'
- Logistic Management and challenges
- Support with covering Product Liability