Regulatory Advice and CE marking process support
Medical devices sold in Europe must bear the CE mark. CE marking is the manufacturer’s declaration that the device complies with the essential requirements of all the directives that apply to it. It indicates to the European regulatory authorities and market that the product may be legally offered for sale.
Manufacturers of devices that fall under any of the medical directives are legally responsible for assuring the products meet all requirements during the entire life cycle. Depending on the product, CE marking may be as simple as formulating a technical file – and keeping it up to date, or as complex as having to submit your products to regular independent scrutiny through a notified body.
Whether you need input in your regulatory approach or strategy, or hands-on support to assemble the technical documentation and prepare your audit and notification process, MDCPartners has a tailored offering of services that will help you meet deadlines.
|Steps to CE marking||Where MDCPartners can assist|
|1||Identify relevant directive(s) and classify the device||Device classification: identify appropriate directive(s), identify correct rules and rationale for correct classification; substantiation of claims|
|2||Identify the applicable standards for your device||We identify the applicable harmonized (and non-harmonized) standards using extensive medical device standards database normScan. We analyze the standards contents and your device or process documentation to identify gaps or substantiate compliance to the standard.|
|3||Check the device against the essential requirements (Annex I) Note: additional req. may apply (other directives) – Clinical Evaluation and Risk Management||We use our checklist against existing documentation and market/regulatory guidelines and standards applicable to the device. We guide through the risk assessment process (ISO 14971) and the clinical evaluation process (Annex X).|
|4||Select and perform Conformity Assessment procedures applicable to the device (Annex II, V, VII)||We assist with the selection of the most appropriate conformity assessment procedure. If needed, we’ll liaise with the notified body.|
|5||Prepare the technical file, comply with national regulations, declare conformity.||We assist with compiling contents and assembling the technical documentation. We review the labeling and/or instructions for use and accompany the notification process.|
Links to the main directives:
- Active Implantable Medical Devices (AIMDD) 90/385/EEC
- Medical Devices (MDD) 93/42/EEC
- In Vitro Diagnostics Directive (IVDD) 98/79/EC