Medical Device CE Marking
How we work on Medical Device CE marking process?
We need to:
- Identify whether the Medical Device Directive / Regulation applies to your product or device.
- Identify the conformity assessment procedure for your product
- Determine the dates by which you must take action
- Identify if there are any Harmonized European Standards applicable to your Medical Device
- Identify non harmonized standards and guidelines that are applicable to your Medical Device.
- Ensure that the Medical Device complies with all the “Essential Safety Requirements (ESR)” / “General Performance and Safety Requirements (GSPR)” of the Directive(s)
- Prepare Medical Device Technical Documentation required by the Directive(s)
- Prepare the Declaration of Conformity and the other supporting documentation required as an evidence of compliance
- Check if any other national requirements exist in the country where the product is to be sold and prepare for compliance to the same.
What are the benefits of CE marking?
CE marking helps you to market your products in the countries of the European Economic Area (EEA). By implementing the requirements you may also find that your product is safer and more reliable; therefore reduce the risk of customer dissatisfaction.
The timelines for certification under Medical Device Regulation (MDR) are as below:
- New application as per Medical Device Regulation (MDR) shall be entertained by most of the Notified Body after September’20 & they shall stop taking application as per MDD from August or September’20
- Certificates which shall be issued under MDD before May’21 shall shall be valid till April’24 & surveillance audit shall be conducted as per MDD only
- So if you wish to get CE certification then above timelines are to be kept in mind.
CE marking on a Medical Device proves that it meets the minimum legal requirements of the relevant Directive, which allows it to be placed legally on the market in any European member state. CE marking gives your company easier access into the European market to sell your products without adaptation or rechecking.
Our team supports clients in meeting “European Regulatory Requirements” that declares the product offered is in compliance with “Essential Safety Requirements” / “General Performance and Safety Requirements” of relevant European safety, health and Environmental protecting regulation according to:
Medical Device Directive (MDD) 93/42/EC amended by 2007/47/EC
European Medical Device REGULATION (EU MDR) 2017/745
Invitro Diagnostic Device Directive (IVDD) 98/79/EC
European Invitro Diagnostic Device REGULATION (EU IVDR) 2017/746
What are EU Directives / Regulations?
An EU Directive is a form of legislation that sets out requirements your products must meet in order to sell them into Europe.
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.
The directives cover a very wide range of product areas including construction products, personal protective equipment and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.
Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives.
Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted. Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".