EU and UK: MDR, EUDAMED, UKRP, MHRA

The most cost-effective approach is to perform a regulatory feasibility assessment before starting registrations. Maytal evaluates your product classification, intended use, claims, technical documentation, and target markets to create a tailored global market access strategy covering Europe, UK, USA, Canada, Australia, Middle East, Asia, and other regions.

In many cases, yes. A well-prepared technical file can serve as the foundation for multiple regulatory submissions. While each jurisdiction has specific requirements, much of the documentation can be reused and adapted, reducing time, cost, and duplication of effort. For this approach to be effective, consultants such as Maytal's regulatory specialists must have a clear understanding of the requirements for registering the products in each target market. This allows the documentation to be prepared from the outset with international requirements in mind, avoiding the need to create entirely new documents for every jurisdiction or make unnecessary changes to the product solely to meet the requirements of a specific market.

Most preliminary classification and regulatory feasibility assessments can be completed within a few days. This allows manufacturers to understand regulatory requirements and applicable standards early in the product development process and avoid costly mistakes later, enabling an effective product verification and validation process and an efficient registration process in target markets.

Yes. Maytal offers a fully managed regulatory service, starting from the early design phase for classification, product and process risk management, software validation, biocompatibility assessment, usability validation, clinical evaluation, full technical documentation development for every target market (not only Europe but also USA, Canada, etc.), quality management systems, EUDAMED, MHRA and GUDID registration, support for relations with the Notified Body or Competent Authority during the registration process, and post-market activities. Our objective is to minimise the workload for manufacturers while ensuring full compliance.

The answer depends on the intended purpose, claims, mechanism of action, and applicable regulations. A correct classification is essential because it determines the regulatory pathway, documentation requirements, and proper market access strategy.

Medical devices are classified according to their intended use into different risk classes. Under MDR, devices can be Class I, IIa, IIb, or III. Under IVDR, devices are classified as Class A, B, C, or D. The classification determines the conformity assessment route and level of regulatory scrutiny.

Most Class IIa, IIb and III devices, and many Class I sterile, measuring or reusable surgical instruments, require Notified Body involvement. Only certain Class I devices may be self-certified.

Timelines vary depending on device complexity, classification, documentation quality, and Notified Body availability. Most projects range from several months to over a year for higher-risk devices.

Required documentation typically includes technical documentation, risk management files, clinical evaluation reports, usability engineering, biological evaluation, post-market surveillance plans, and declarations of conformity.

The Basic UDI-DI is the primary identifier for a family of devices under MDR and IVDR. It is required for EUDAMED registration and many regulatory activities.

Yes. As EUDAMED becomes mandatory, manufacturers placing devices on the European market must ensure that their products are properly registered within the required deadlines.

Yes. Maytal can manage the complete EUDAMED registration process without the involvement of company staff, or at most with minimal involvement in cases of uncertainty regarding the products to be registered.

Legacy devices are products originally certified under the Medical Device Directive (MDD) that continue to benefit from MDR transition provisions. These devices remain subject to specific MDR obligations despite not yet holding MDR certificates.

A Clinical Evaluation Report demonstrates that a device is safe and performs as intended based on clinical evidence. CERs are required for all medical devices under MDR.

Many devices can rely on published literature, equivalent devices, and existing clinical evidence. However, some products require new clinical investigations to demonstrate safety and performance, especially if they have new features and/or there are no equivalent CE-marked devices available on the market.

ISO 13485 is the internationally recognised quality management system standard for medical device manufacturers. While not legally mandatory, it is effectively required for most regulatory submissions.

Yes. Maytal can support manufacturers requiring EU Authorised Representative and UK Responsible Person services.

Manufacturers must comply with UK regulations, appoint a UK Responsible Person where required, and complete the appropriate MHRA registrations.

Manufacturers must implement ongoing post-market surveillance, vigilance reporting, trend analysis, complaint handling, periodic safety updates, and corrective actions where necessary to respond to MDR requirements. With the entry into force on 16 June 2025 of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, these requirements also apply to the UK.

The cost of medical device regulatory services depends on several factors, including the target market, device classification, the complexity of the product, and the scope of support required.

Manufacturers may choose a fully outsourced, turnkey registration service or request assistance with specific regulatory activities, such as the preparation of technical documentation, Clinical Evaluation Reports (CER), Biological Evaluation Reports (BER), Risk Management documentation, Post-Market Surveillance (PMS) documentation, or other specialised services. In addition, official fees charged by regulatory authorities or Notified Bodies may apply.

The most effective way to estimate the overall project cost is to begin with a regulatory feasibility assessment. This enables Maytal to evaluate your product, identify the applicable regulatory pathway, define the required activities, and provide a tailored quotation with a clear project scope and realistic timeline.

Yes. Software and AI applications may be regulated as Software as a Medical Device (SaMD) if they diagnose, monitor, predict, or influence clinical decisions. Maytal experts can support the company in evaluating whether your software, including AI-based software, is a SaMD and needs to be managed under MDR in Europe, as well as in other markets (e.g. USA with FDA, Canada with HC, etc.).

FDA registration is a different process from CE marking. The FDA's classification rules differ from those in Europe. FDA registration certainly requires the company to prepare technical documentation for product validation and registration, which can also be used for CE marking and vice versa; however, the product registration processes and requirements are different. This means that additional documentation and conformity assessment activities are usually required.

Common mistakes include incorrect classification, weak design documentation (e.g. risks not properly identified, usability validation missing, a biocompatibility assessment that does not properly account for certain biological risks or contact times, etc.), weak clinical evidence, incomplete technical documentation, inadequate risk management, poor post-market surveillance planning, and delayed EUDAMED preparation.

Regulatory consultants provide specialised expertise, reduce project timelines, avoid costly compliance mistakes, support interactions with Notified Bodies and authorities, and help manufacturers focus on product development and commercial growth.