The start of a new year provides an opportunity to reflect on both personal and business goals and to focus on building momentum for the months ahead. In the medical device field, these goals are inherently tied to the regulatory landscape, which varies significantly across regions. Last year, there were substantial efforts made toward harmonization, along with growing attention to cybersecurity, data safety, machine learning (ML), and artificial intelligence (AI). These trends are expected to intensify in 2025 with the introduction of more stringent ISO/IEC standards, particularly in digital health technologies. As the regulatory landscape continues to evolve, one key question remains: What will the regulatory environment look like this year, and how can medical device manufacturers set effective business goals or seize opportunities for new market growth?

United States

The U.S. Food and Drug Administration (FDA) has consistently taken the lead in regulatory controls, regularly publishing and updating guidelines to communicate its current thinking on special controls for device manufacturers. Examples of these guidance documents include those related to software, cybersecurity, AI, companion diagnostics, next-generation sequencing techniques, and various device categories.

The FDA outlines its planned guidance work each year. The “CDRH Proposed Guidances for Fiscal Year 2025” includes such topics as software, AI, cybersecurity, 510(k) submissions, Emergency Use Authorization, the Q-Submission Program, and Laboratory Developed Tests (LDTs).

The FDA plans to extend the electronic Submission Template and Resource (eSTAR) by Oct. 1 for De Novo submissions. The agency aims to expand this interactive PDF form to additional submissions such as 513(g) and support this expansion through finalized guidance documents.

As part of its final rulemaking policy for in-vitro diagnostics (IVDs) offered as laboratory-developed tests (LDTs), the FDA will begin phasing out its general enforcement discretion approach in five stages over four years. The first stage starts on May 6 and requires LDT manufacturers to comply with medical device reporting requirements, correction and removal reporting, and quality system (QS) requirements for complaint files. The more stringent LDT requirements may be accompanied by some reclassifications of Class III (high-risk) IVDs to Class II (moderate risk), primarily affecting infectious disease and companion diagnostics. This change is intended to simplify the marketing clearance process for IVD manufacturers, including those that may have “marketed” these devices as LDTs so far.

Canada

Health Canada’s “Forward Regulatory Plan: 2024-2026” outlines several key initiatives aimed at modernizing regulations across various product categories. A major focus is updating the Food and Drug Regulations, Natural Health Products Regulations, and Medical Devices Regulations to establish a more flexible, risk-based clinical trial framework. This modernization aims to better accommodate innovative and non-conventional trial designs.

Another significant aspect of the plan involves updating the Medical Device Establishment Licensing framework and amending the Canadian Medical Devices Regulations. 

Additionally, the joint pilot program for a single eSTAR submission, initiated in 2023 between Health Canada and the FDA, is likely to yield results this year. The Dual eSTAR Submission aims to simplify medical device approvals in both the U.S. and Canada; a key feature of this program could include the automatic deletion of region-specific attachments when selecting the country for submission, thus simplifying the process for manufacturers.

Europe, the U.K., Switzerland

Due to various Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) amendments, some device manufacturers may not yet need to fully comply with the EU regulations MDR and IVDR (legacy devices regulated under MDD or IVDD). For an increasing number of medical device manufacturers, however, the MDR and IVDR will soon be applicable as the transitional provisions for their legacy devices will end. This means the devices can no longer be marketed, or their EC certificates will expire, requiring a full transition to the MDR or IVDR for CE marking. 

Manufacturers conducting a conformity assessment with a Notified Body for the first time must adapt their documentation by creating a more structured and organized Technical Documentation and Quality Management System (QMS). They must also provide clinical evidence, may need to reclassify their devices, implement post-market surveillance, conduct vigilance activities, and ensure traceability across the supply chain, including suppliers, distributors, and importers.

Additionally, medical device manufacturers and startups now have certain obligations they must fulfill for foreseeable supply interruptions or termination under Article 10a of the MDR/IVDR.

Starting May 26, a Unique Device Identifier (UDI) will be required for Class I medical devices, Class B, and Class C IVDs. EUDAMED modules may also become mandatory six months after being published, once they have been audited.

May 26 is also the deadline for IVD manufacturers to have an IVDR-compliant QMS in place, regardless of the classification. Moreover, Class D device manufacturers must apply for an IVDR conformity assessment with a Notified Body by this date and sign a written agreement with a Notified Body by Sept. 26, 2025.

Furthermore, the new General Product Safety Regulation (EU) 2023/988 and EU Product Liability Directive 2024/2853—implemented last year—have changed legal compliance requirements for producers of products marketed in the EU. Manufacturers now must adapt their internal processes to meet the legal requirements in 2025 to avoid liability for damage caused by product defects, including software- and AI-supported medical devices.

The U.K.’s MHRA plans to introduce a number of new regulations this year focusing on digital mental health technologies, AI development and deployment, UDI, implant cards, and IVDs. These regulations will further amend the U.K. Medical Device Regulations (2002), which allow transition periods for CE-marked devices until June 2028 or June 2030, depending on specific conditions. The MHRA is also discussing approvals for certain medical devices already approved by the U.S. FDA, Health Canada, and the TGA Australia.

In Switzerland, most Swiss medical device legislation has been aligned with EU regulations (MDR and IVDR), though no mutual agreement exists with the EU. The amended Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO), effective Jan. 1, reflects recent changes triggered by Regulation (EU) 2024/1860. These include extended medical device certificate validity and more time for healthcare institutions to prove IVDR compliance for in-house tests. A simplification of labeling requirements for professional IVDs is also under discussion.

Latin America

Like other regions, Latin American countries are moving towards greater regulatory harmonization, aligning more closely with international standards. Brazil’s ANVISA has updated the Essential Safety and Performance Requirements for Software as a Medical Device (SaMD); devices used by laypeople; implantable medical devices; and Class II, III, and IV IVDs under RDC 848/2024. This update mirrors the General and Safety Performance Requirements found in the EU Regulations (MDR/IVDR Annex I) and the international guidance document IMDRF/GRRP WG/N47FINAL: 2018

In Argentina, a new medical device regulatory framework (Resolution 237/2024) is set for implementation on March 28. This framework will broaden recognition of foreign certifications and tests, shift the responsibility for verifying compliance with technical regulations from customs to the health agency, introduce post-market surveillance requirements, and include a new conformity marking (QR code).

Asia-Pacific

Last year, China’s National Medical Products Administration released a draft of the China Medical Device Administration Law. If enacted in 2025, this regulation will significantly update existing laws, focusing on compliance with China’s compulsory product standards (Chapter 3). It will also introduce greater liability for local legal representatives of foreign marketers and key personnel of medical device registrants and filers. The draft includes a five- to 15-day detention period for various violations.

India, now an affiliate member of the International Medical Device Regulators Forum (IMDRF), is expected to fully implement its new Medical Devices Rules, significantly impacting regulatory processes for both domestic and international companies. To create regulatory uniformity, the government plans to classify about 1,178 medical devices into four categories based on their risk profile under the Medical Device Rules, 2017.

In Japan, amendments are expected to Japan’s Pharmaceuticals and Medical Devices Act administered by the MHLW. Increased demand for in vitro diagnostic devices such as SARS-CoV-2 testing kits has highlighted the need to streamline the registration and certification process for medical devices. This includes establishing post-marketing regulations for information collection, evaluation, and reporting by manufacturers and distributors. The examination process for SaMD is also being revised.

South Korea’s Digital Medical Products Act took effect in January 2025. This rule establishes classification standards, permission (certification and reporting) procedures, clinical performance tests, labeling requirements, and follow-up management methods for digital medical technologies. 

Setting Regulatory Goals and Capitalizing on Opportunities

This overview of regulatory changes is not exhaustive, but it underscores the critical importance of staying informed about country-specific regulations for medical devices. The anticipated regulatory developments in 2025 present both challenges and opportunities for manufacturers, whether they seek to maintain compliance in existing markets or expand into new ones. To remain compliant and competitive, companies need a strong, adaptable regulatory strategy. Those that can adjust efficiently will be well-positioned for growth and entry into new markets. For new devices or technologies, this presents a prime opportunity to innovate and differentiate from competitors.

A proactive approach—identifying and addressing potential weaknesses before regulators do—will be essential. Partnering with regulatory experts who have in-depth knowledge of regional regulations and can provide tailored guidance will streamline the compliance process. This strategy not only saves time and resources but also ensures that manufacturers can meet their regulatory goals for 2025. With limited time to act, now is the moment to take decisive steps toward securing compliance and capitalizing on growth opportunities.

Dr. Oliver Eikenberg has almost three decades of medical device expertise, including 14 years in R&D, manufacturing, and quality control, and 15 years in medical device and IVD regulatory and quality affairs consulting. He is also an expert in global medical device regulations and an auditor for Quality Management Systems. Prior to joining Pure Global, Dr. Eikenberg was a senior RA/QA Consultant, internal auditor, and lead IVDR manager at Emergo by UL Solutions for 10 years.