CE marking – Medical Devices
What is CE marking for medical devices?
The CE marking for medical devices is a conformity mark that indicates that a medical device complies with the essential requirements set out in the applicable European directives. This marking is mandatory for medical devices that are intended to be marketed and used in the European Union (EU) and the European Economic Area (EEA). From 2003 to 2017, the main EU standard was Directive 93/42/EEC. In 2017, this directive was replaced by Regulation 2017/745, which, being a regulation, does not require transposition by the states belonging to the European community. This regulation is designed to ensure that medical devices marketed in the EU meet high standards in terms of safety, efficacy and quality, for the benefit of public health and patient safety. It defines what is meant by a medical device and what documents are required, from the design phase, to the placing of the product on the market and post-market surveillance. Regulation 2017/745 also defines the classification of medical devices, dividing medical devices into 4 classes:
Class I (no certification by a notified body required, affixing the CE Marking is the responsibility of the manufacturer alone)
Class IIa
Class IIb
Class III
For all medical devices other than those belonging to Class I, certification by a third-party body is required. The list of Notified Bodies (NB) for the certification of medical devices in the European Union is available on the European Commission’s website. This list can be accessed through the official online database ‘NANDO’ (New Approach Notified and Designated Organisations).
There is a variability in the duration of the CE Marking certificate depending on the Notified Body chosen, with a maximum duration of up to 5 years.
How can we help you?
Orlando Engineering & Consulting offers its consultancy both for obtaining a new certification and for maintaining an existing one.
Orlando Engineering & Consulting also offers its consultancy to draw up the Project File, the Technical File, the STED and all other documents required for certification.
Consultancy in this area may be limited to a single phase of certification or be present and extended from the conception of a new medical device through to its marketing. In this case, the consultancy is divided into the following main phases:
- Meeting, without obligation, at the client’s company to assess the operational phases and formulate an offer.
- Evaluation, together with the management, of the best strategy to deal with the certification process and evaluation of resources.
- Meetings, at a frequency determined together with the management, for the parallel management of activities.
- Support to the company in drawing up documents and verification audits prior to the notified body audit.
- Support during the certification audit and during the resolution of any non-conformities and observations arising during the audit.