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REGULATORY AND QUALITY

European Regulatory Services

All medical devices placed on the market in Europe must currently comply with one of the European Directives for medical devices, namely the Medical Device Directive 93/42/EEC, the In Vitro Diagnostic Directive 98/79/EC, or the Active Implantable Medical Device Directive 90/385/EEC, and carry the CE mark as the legal indication of compliance. The CE mark is affixed to the product by the manufacturer after completing an appropriate conformity assessment process. However, in May 2017, two new European Regulations replaced these three Directives, these being the Medical Devices Regulation (EU) 2017/745, and the In Vitro Diagnostic Device Regulation (EU) 2017/746. After May 2020 for medical devices and May 2022 for IVDs, devices placed on the European market must comply with these new Regulations, even well-established ‘legacy’ devices must go through the new conformity assessment process in order to remain on the market after these dates. There are exceptions to the dates of mandatory compliance, based on the expiry dates of MDD/IVDD Notified Body certificates. DLC can provide an interpretation of these exceptions for your devices, if required.

With senior regulatory consultants having many years of experience in medical devices, IVDs and combination products, Donawa Lifescience Consulting (DLC) is ideally placed to help with every aspect of the CE marking process, to both the current Directives and the superseding Regulations.

For medical devices, the routes available for manufacturers to obtain the CE mark depend on a number of factors, including risk classification, type of product, internal quality management system and human/technical resources. For higher risk devices, the CE mark can be affixed only after involvement of a Notified Body, to either verify compliance of the product with the ‘Essential Requirements’ and/or the manufacturer’s quality system with regulatory requirements. Once your device is on the market, additional requirements apply in relation to the reporting of adverse incidents to the Competent Authorities designated by each EU member state.

DLC provides a fully comprehensive service to help you market your medical devices in Europe, from simply answering questions on the process to a significant involvement in quality system development and assessment, classification rationale, technical file and design dossier preparation, including standards identification, Essential Requirements compliance, risk analysis, clinical evaluation and manufacturing documentation, together with post-market surveillance and reporting.

For further information and assistance, please contact us to see how we may be able to assist you.

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