An Informative article about Clinical Evaluation Report CER) as per MEDDEV 2.7/1 Rev. 4
Latest requirement to fulfill MDD compliance for Medical Device Manufactures!!!
Clinical Evaluation Reports (CERs)
Preparing a clinical evaluation report (CER) is time consuming and always need the support of skilled consultants. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER).
What are included in Clinical Evaluation Report?
- Published and Unpublished Literature Search and consolidate a Report .
- Selection of Databases from the above
- Selection of Key Words based on the technical File and Design Parameters .
- Inclusion & Exclusion Criteria
- Addressing Risks .
- Review of Post-Market Surveillance
- Appraisal of Clinical Literatures .
- Review and Update of Clinical Evaluation Reports (CERs)
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Medical Device Regulation in USA is formulated and controlled by FDA via Section 510k of the act. However, in Europe its via MDD directive so called CE Marking
Reading this article will help those unfamiliar with 510k and CE marking effectively prioritize their regulatory efforts.
510(k) is the preferred route to reach the Largest single market (USA) whereas CE Marking is the preferred route to reach 37 European counties and very interestingly it is widely accepted in Australia, Middle east and Asia pacific Counties.
Do not be the impression that once the 510(k) is in place it will be easy to obtain a CE Mark. Understand there are differences in the process and compliance procedures. The medical device classification based on the risk itself is different In 510k the classification is Class 1, Class 11 & Class 111 whereas in CE Marking its starts from Class 1, Class 1a, Class 1m, Class 11a, Class 11b and Class 111.
510k referred either abbreviated or traditional methods for meeting the compliance requirement, whereas CE Marking the manufacturer must demonstrate their device complies with one of the European Union’s Directives related to ‘medical’ products: the Medical Device Directive (93/42/EEC), the In-Vitro Diagnostic Medical Device Directive (98/79/EC), or the Active implantable Medical Device directive (90/385/EEC).
US has a mechanism the regulatory authority (Food & Drug Administration) itself controls review approval and inspection for the devices planning to market whereas in Europe each Member State in the European Union has a Competent Authority. These competent authorities appointed Notified Bodies responsible for review approval and inspection for the devices as per CE marking directives.
The FDA 510k and CE Marking process starts with understanding the class of the device. Class 1 device exempted from 510k and similarly exempted by notified body certification
Once you identified the class and predicative device followed by product testing, 510k preparation has to be started and 510(k) application is submitted to CRDH/FDA along with 510k submission File. Whereas CE Marking Technical File to be prepared and submitted to Notified Body.
Class I devices without a measuring function and which are not sterilized do not need to be audited. The manufacturer can self-declare and place on the market with appropriate documentation.
During the review period the clients has the time period to implement QMS/ GMP in the organization. For FDA insists for Implementing 21 CFR 820 (GMP) whereas MDD CE Marking it is mandatory to Implement EN ISO 13485.
For manufacturers cleared 510k need not want to face any onsite audit before listing. In the case of CE Marking usually requires at least two audits a screening audit to review the QMS for compliance with EN ISO 13485 and the associated directive. A full-fledged onsite audit also known as certification audit will be carried out and based on successful completion CE Certificated is awarded.
If you are outside the EU, you must contract an ‘Authorized representative’ to act on your behalf, which is similar to the FDA’s requirement for an US Agent if you are a foreign importer of medical devices into the US.
A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the Medical Devices CE Marking directives are carried out in that particular member state.
The European Union (EU) comprises 28 member states. Each member state is party to the founding treaties of the union and thereby subject to the privileges and obligations of membership.
Notified Body is a certification organization, which the national Competent Authority of a member state designates to carry out one or more of the conformity assessment procedure according to Medical Device Directive and Issue CE Certificate.
Each notified body will be assigned one unique four digit number which will be affixed below the CE Mark logo.
National Drug Code (NDC Code)is a ten digit unique product identifier number for human drugs.
This will be requested by the US Agent along with Establishment Registration. The first 5 digits will be provided by FDA and the other 5 digits manufacturer has identify
More information about NDC Labeller code
I 3 CONSULTING help the below type of manufactures to sell the products in US Market by completing FDA Establishment Registration.
- OTC Drug
- Testing Laboratories
- Dietary /Food Supplement
- Active Pharmaceutical Ingredient (API)
Drug Establishment Process details
We are consultants and US Agents helping those interested to market in USA.
Our annual fees is comparatively lower than others and services are mush faster.
Online application process and online payment facility helps exporters to comply regulation much faster.
Details about Establishment Registration
Foreign and Domestic Medical Device Manufacturers and initial distributors / importers must register their establishments with the FDA.
All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
Medical devices are classified into Class I, II, and III.
All the devices need to register with USFDA before marketing in USA.
Most Class I devices are exempt from Premarket Notification 510(k) AND most Class II devices require Premarket Notification 510(k), before registration and Listing
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S.A must follow and comply Read More about further activities and Medical Device Establishment Registration
Failure to register your facility – No entry of listed food and related products to USA. It will be send back to original destination OR destroyed.
Food manufactured, processed, packed, received, or held by a registered facility has failed in random inspection of FDA inspectors , It will be send back and suspend the registration.
All about Food FACILITY registration