Medical Devices-USA/Europe Regulatory News – March 2023

USA (US FDA)

Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff

The guidance describes the Food and Drug Administration’s (FDA) approach regarding manufacturers’ compliance with FDA’s performance standards for laser products. FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product (see 21 CFR 1040.10(b) (21)).

The Agency sets radiation safety product performance standards that must be met by manufacturers in order for laser products to be legally sold in the U.S. market. Laser products may fall under both the definition of a medical device and that of an electronic product, under sections 201(h) and 531(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), respectively. Such products are subject to the provisions of the FD&C Act and its implementing regulations that apply to medical devices1 and electronic products.

Medical X-Ray Imaging Devices Conformance with IEC Standards-Guidance for Industry and Food and Drug Administration Staff

This guidance addresses diagnostic x-ray imaging systems and their major components (see 21 CFR 1002.1 and 21 CFR 1020.30(a)(1)). Most diagnostic x-ray imaging systems and their major components are classified as Class I or II devices. And also includes the regulations and product codes for these devices.

This guidance does not address radiation therapy products because there are no EPRC performance standards promulgated for these products. These devices are cleared for market through the 510(k) process.

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices- Guidance for Industry and Food and Drug Administration Staff

The scope of this Guidance is limited to ultrasonic diathermy devices regulated under 21 CFR 890.5300(a), product codes IMI and PFW, which are class II devices.

This guidance is applicable to ultrasonic diathermy (physiotherapy) devices for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms, and joint contractures. This guidance only relates to equipment employing ultrasonic energy at a frequency beyond 20 kilohertz, using a single plane circular transducer per treatment head, and producing non-convergent beams perpendicular to the face of the treatment head. 

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff

This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Safety of diagnostic ultrasound technology

Exposure of tissues to intense levels of ultrasound that are well above the levels found in typical diagnostic ultrasound devices can have significant biological effects. Therefore, determinations of substantial equivalence have been made in part by comparing the appropriate acoustic output levels of new devices to those of predicate devices of this type that were on the market prior to May 28, 1976, the date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), which are known as “pre-amendments devices. 

Assembler’s Guide to Diagnostic X-Ray Equipment-Guidance for Industry and Food and Drug Administration Staff

This guidance document provides Question and answers regarding Policy. The Assembly of Certified Diagnostic X – Ray Equipment.
The answers addressed in the guidance are:

• General Responsibilities of Manufacturers of Diagnostic X-Ray Equipment
• General Responsibilities of Assemblers of Diagnostic X-Ray Equipment
• Policy ­ The Assembly of Certified Diagnostic X­ray Equipment

Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide

This guidance document provides Question and answers regarding Rule entitled “Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components” (70 FR 33997; subsequently referred to as “the rule”), which amended the performance standard for diagnostic x-ray systems and their major components.

FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities to comply with these changes in the performance standard, which became effective June 10, 2006. Regulations (88 FR 3638; January 20, 2023), removed certain reporting requirements for diagnostic x-ray systems and their major components and the current version of this guidance reflects these changes.

CANADA (HEALTH CANADA)

Medical Device License Application Review Fee Form

Refer below link for the Medical Device Application fee form.
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/forms/medical-device-application-fee-form-fra.pdf 

EUROPE

MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a common understanding of these terms and concepts is necessary for an effective and harmonised implementation of the vigilance requirements under the MDR.

The document is non-exhaustive and should be read in conjunction with the MDR, relevant standards and MDCG guidance documents. Terms and concepts that are outlined in the corresponding articles of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this document.

REGULATION (EU) 2023/ OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

The European parliament voted for the extension of the transition period of the medical device regulation and in vitro diagnostic device regulation. The specific Provisions are

• To implement a MDR Compliant QMS
• To have a contract signed with Notified Body by 26 May 2024

For IVDR, the sell off period is cancelled and IVD can continue to be made available without time limit.

Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales.

The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.

SWITZERLAND (Swissmedic)

BW617_00_003e_MB Abweichung MdEP (Information sheet Derogation MEP)

The information sheet provides information on the options for the placing on the market and putting into service of medical devices1 in Switzerland, which do not fully comply with the requirements of the Medical Devices Ordinance (MedDO, SR 812.213) / Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).

Any manufacturer that places a device on the market in Switzerland must carry out an assessment of its conformity in accordance with the valid conformity assessment procedure before the device is placed on the market. The manufacturer and importer must be able to prove that such an assessment of conformity has been carried out and that the product is conforming. MedDO and IvDO also specify requirements for the languages of the product information.

FINLAND (FIMEA)

New and updated MDCG guidance published to support medical device operators

Every medical device manufacturer should be familiar with the regulations regarding their products, i.e. the EU Medical Device Regulation 2017/745 (MDR) and the in Vitro Diagnostic Devices Regulation 2017/746 (IVDR). The requirements of the regulations are presented on a general level, which is why it is not always clear from the text of the regulation to conclude how the regulation is applied in one’s own case.

To support the interpretation of the regulations, expert working groups have drawn up so-called MDCG guidance documents. Some of the MDCG instructions clarify some rather limited topic, such as the content of the periodic safety review, while some describe more broadly, for example, the principles of interpretation of transitional provisions.
United Kingdom (MHRA)

Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates. 

The key changes include:

• Extend the transitional period for higher-risk devices (class III and certain class IIb implantables) such as pacemakers to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).  (other class IIb devices, class IIa, class Im, Is and Ir devices) such as syringes to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
• Extend the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021. Subject to meeting specific conditions, this extension also applies to those certificates that expired before the amendments took effect.

These changes made to the EU MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.

MHRA frames regulation as a ‘fundamental part’ of realizing its Medical technology strategy

The government has published an inaugural medical technology strategy designed to make the UK a more attractive market by “improving access, shaping our own regulatory framework, leading in research and development and maintaining a strong international market presence.”

Regulation is at the heart of the strategy. Since leaving the European Union, the UK has created new medical device regulations to replace the CE mark with the UKCA mark and strengthen the powers of the Medicines and Healthcare Products Regulatory Agency (MHRA) to protect patients. Now, officials have released a broader strategy for the industry and articulated the role regulation plays in the plans.

Ireland (HPRA)

HPRA process for Article 97 and notified body certificates

According to guidance in December 2022 the Medical Device Coordination Group published guidance (2022-18) on the use of Article 97 of the Medical Devices Regulation (MDR). The guidance allows for a controlled period of non-compliance for certain devices affected by the capacity challenges of notified bodies under specific conditions.

We have developed a process to use Article 97 for expiring or expired Directive certificates subject to meeting specific criteria. It will be used as a short-term measure to avoid disruption to the supply and availability of medical devices and healthcare in Ireland.