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The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..

Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil. According to the new Reliance route which started June 3, ANVISA will now rely on the decisions of authorities from other jurisdictions, but remains independent and respo..

A recent round of inspections by the Dutch Health and Youth Inspectorate (IGJ) has found that more than one-third of European Authorized Representatives (ARs) operating in the Netherlands have yet to meet all requirements applicable under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). European Authorized Representatives under supervisionE..

This week the UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week public consultation seeking the views of various stakeholders to improve safety measures for high-risk IVDs by including Common Specification (CS) requirements in the UK legislation (Medical Devices Regulations 2002 (MDR 2002)). In addition, they also seek..

This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market. The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted a webinar in March on the update of the draft medical devices scope, classification and essential requirements. This was a..

This is the second in our series of regulatory updates on the EU AI Act. We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-..

On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

This is our fourth update on the recently released draft standard for medical device labeling published by Mexico’s medical device regulator COFEPRIS, NOM-137-SSA1-2024. Background on NOM-137-SSA1-2024COFEPRIS released (March 12) a new draft of the NOM for Medical Device labeling, NOM-137-SSA1-2024. We posted part 2 and part 3, to further clarify the proposed medical device labeling standard. In..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..

We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical de..