REGULATORY

Creating and innovating medical devices or new software solutions is at the heart of human health. With safety being a crucial vector, patients and medical teams needs assurances that each product is rigorously tested, certified and compliant in the market it is used. We offer a host of solutions and services, find out more below…

Regulatory & Compliance

CE Marking

We have extensive knowledge developing Quality Management System (QMS), Technical File and Risk Management Documentation in order to attain a CE Mark for new medical device(s).

We have experience of working with all classes of medical device (Class I, IIa, IIb and III) across a wide range of product types.

Software as a Medical Device (SaMD) is a core specialism. It classifies a device (under Rule 11 of the new Medical Device Regulation) and prepares the relevant documentation to ensure compliance with the new MDR, IEC 62304 and ISO 27001.

MDR Transition

The new Medical Device Regulation (MDR) came into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).

The MDR applies to all manufacturers selling medical devices into Europe and requires them to update both their processes and technical documentation to satisfy the new requirements. It introduces greater scrutiny of technical documentation, clinical evaluations, post-market clinical follow-ups (PMCF) and demands end-to-end traceability of medical devices through the supply chain.

All new medical devices introduced to the market after May 2021 deadline must conform to the new MDR. We ensure medical devices the IDC helps bring to market remain compliant and able to be sold within the EU.

Market Access & Compliance

To enter American, Canadian, Brazilian, Japanese, or Australian markets you will need to be in compliance with Medical Device Single Audit Program (MDSAP) requirements. MDSAP enables a certification body to perform a single regulatory audit of ensure we comply with the relevant requirements of the participating regulatory authorities.

Using a Quality Management System (QMS) that identifies any non-conformities, we producing a report that help gain access to a wide range of markets across the world including:

UK / EUROPE / USA / CANADA / ASIA / AUSTRALASIA

Software Quality Assurance

We are highly qualified in Software Quality Assurance and Regulatory Advice to industry and academia with our team having many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU.

Our knowledge includea the following devices:

Medical devices (and accessories)
In-vitro diagnostic devices (and accessories)
Wellness / lifestyle devices
Software as a medical device (SaMD) including mobile, web and cloud-based applications

We also cover:

DCB0129 / DCB0160: Clinical Risk Management in Health IT Systems (NHS Digital) Compliance
Access to the NHS Marketplace
Cyber Essentials / Cyber Essentials Plus Certification
IEC 62304: Software life cycle processes Compliance
ISO 27001: Information security management Compliance
GDPR Compliance

We ensure a total solution for CE Mark/FDA registration.

EU MDR and IVDR UDI Compliance Solutions

Under EU MDR & IVDR, most Medical Devices and SaMD must bear a Unique Device Identifier (UDI).

The EU MDR & IVDR requires medical device labellers to Place UDI-DI (Device Identifiers) and UDI-PI (Product Identifiers) on device labels and packaging.

All classes of MDs & IVDs must assign a Basic UDI-DI, UDI-DI’s & UDI-PI’s and upload these to:

EUDAMED
MHRA DORS device registration
Technical documentation
Device labels (direct marking), where applicable
Packaging labels, where applicable.

The UDI-DI & UDI-PI must appear in machine readable (AIDC) and human readable (HRI) formats on the device and packaging labels.

UDI=UDI-DI + UDI-PI

The DI defines the labeller as well as the device version or model.

The PI defines characteristics such as manufacturing / production date, lot or batch number, expiry date etc.

European Device Solutions Limited & European Healthcare & Device Solutions (Ireland) Ltd provide simple, low cost solutions for UDI & EUDAMED requirements.

For more info about regulatory