MDCG 2022-16 – Guidance on Authorised Representatives

The Medical Device Coordination Group (MDCG), composed of representatives from all EU Member States and chaired by the European Commission, has endorsed new guidance clarifying the requirements for authorised representatives, manufacturers, and other economic operators under Regulations (EU) 2017/745 and 2017/746. Where relevant, links to additional MDCG guidance are provided for further clarification.

MDCG 2019-6 Rev.4 – Q&A on Requirements for Notified Bodies

This updated Q&A document outlines key requirements for notified bodies under the MDR and IVDR. Developed based on issues identified during joint assessments, the document will continue to evolve as new questions arise.

Survey on Notified Body Certifications and Applications

In the October 2022 survey, 47 of 51 notified bodies responded. Results include comparison with April 2022 data. MDR application and certification figures may be slightly underestimated due to missing data from recently designated NBs.

Expert Opinions under the Clinical Evaluation Consultation Procedure (CECP)

Independent experts, as defined under MDR Article 106, have issued scientific opinions on notified body clinical evaluation assessment reports (CEARs) for high-risk devices under MDR Article 54. These expert evaluations form a critical additional layer of conformity assessment for specific device categories.

Team-NB Position Papers on Cybersecurity and Off-Label Data

Team-NB has released new position papers addressing cybersecurity threats and data produced from off-label device use. As connected medical technologies expand—from wearables to implantables—the need for modern, harmonized cybersecurity frameworks is becoming increasingly urgent.

Swissmedic Inspections of Swiss Authorised Representatives (CH-REP)

Swissmedic conducted focused inspections of Swiss authorised representatives during the first half of 2022 to verify compliance with national market provisions.

MedTech Europe Calls for Respect of NLF Principles in the AI Act

MedTech Europe, alongside other industry groups, urges EU legislators to preserve the New Legislative Framework (NLF) structure in the Artificial Intelligence Act to ensure consistency and safeguard product quality and safety across the European market.

Guidance on Manufacturer Vigilance Reporting

MHRA has issued updated guidance for manufacturers on reporting adverse incidents and field safety corrective actions for devices placed on the UK market. Manufacturers must ensure timely reporting and maintain device safety and performance throughout the product lifecycle.

Extension of Medical Device Regulation Transition Period

The UK government will introduce a 12‑month extension to the implementation of future Medical Device Regulations, targeting full enforcement by July 2024. Transitional arrangements will extend recognition of CE‑marked devices on the Great Britain market. Further legislation, including updated post-market surveillance requirements, is planned for Spring 2023.

Software and AI as a Medical Device Change Programme

MHRA has launched a comprehensive reform program addressing regulation of software—including AI—used as medical devices. The programme aims to maintain patient safety while supporting responsible digital innovation and establishing the UK as a global leader in medical software regulation.

Public Consultation on 2023 Regulatory Fees

HPRA is seeking feedback on the proposed fee structure for 2023 covering Human Medicines, Compliance Activities, Blood, Tissue Establishments, Organs, and Medical Devices. The consultation guidance outlines when and how stakeholders should be engaged, in alignment with statutory and international obligations.

Least Burdensome Provisions – Developing and Responding to Deficiencies

FDA’s guidance outlines how staff should issue requests for additional information on device marketing submissions using the least burdensome approach. The document also provides recommended formats for deficiency letters and industry responses.

Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

FDA’s Center for Devices and Radiological Health is launching the TAP Pilot as part of the MDUFA V agreement. Starting in FY 2023, this voluntary program aims to demonstrate improved early engagement between FDA and stakeholders to expedite safe and effective device innovation.

Postmarket Surveillance Under Section 522

FDA has published guidance to help manufacturers comply with 522 postmarket surveillance orders, including expectations for study design, reporting, and fulfillment of regulatory obligations.

General and Plastic Surgery Devices Panel – Advisory Committee Meeting Notice

FDA has announced an upcoming advisory committee meeting to gather expert input on regulatory issues related to general and plastic surgery devices.

User Fees and Refund Guidance for PMAs, BLAs, and 510(k)s

FDA has updated guidance describing fee requirements, exemptions, and refund conditions for PMAs, BLAs, and 510(k)s. The updates reflect process improvements introduced under MDUFA V and clarify how user fees apply to different submission types.

FDA and Industry Actions Affecting Review Clocks for De Novo, 510(k), and PMA Submissions

Following amendments made by MDUFA V, FDA has updated how review timelines are calculated for De Novo requests, 510(k) submissions, and PMAs. The additional user fee resources are intended to improve consistency, performance, and transparency in the review process.

Software as a Medical Device (SaMD) – Q&A on RDC 657/2022

ANVISA has released a Q&A document supporting implementation of RDC 657/2022 on Software as a Medical Device. The document clarifies regulatory expectations, supports consistent interpretation, and guides manufacturers, distributors, health services, and inspectors on the correct application of SaMD requirements.