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Regulatory Affairs Updates 16/21

Medical Devices - Guidelines and Regulations Worldwide


Europe

Transition periods of class D IVDs

Another MDCG guidance document has seen the light of day: "Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746". This document deals in detail with the integration of so-called EU reference laboratories (EURLs). These will be consulted by the Notified Body during conformity assessment procedures when no common specifications (GS) exist for a class D in vitro diagnostic device.

The most important news: an IVD product can obtain its certificate before the IVDR comes into force on May 26, 2022, even without the involvement of a EURL. This is fortunate, because these are not yet certified themselves...


„New Approach“ and „New Legislative Framework“

MDCG document 2021-5 on standardization in medical technology is also hot off the press. It describes the European "New Approach" and the "New Legislative Framework" with regard to the medical device sector. Among other things, these approaches give rise to the use of harmonized standards and the resulting assumption of conformity when these are applied.

Although this Guidance does not contain any new information, it does provide some important clarification on the state of the art and the tasks of Notified Bodies, because harmonized standards can be applied, but do not have to be!


International News

USA

The FDA has updated eight classification regulations related to devices using software:

Classification Regulation (21 CFR)Device Type (existing product code(s))
862.2100Calculator/Data Processing Module for Clinical Use (JQP, NVV)
862.1350Continuous Glucose Monitor Secondary Display (PJT, PKU)
866.4750Automated Indirect Immunofluorescence Microscope and Software-Assisted System (PIV)
880.6310Medical Device Data System (OUG)
884.2730Home Uterine Activity Monitor (LQK, MOH)
892.2010Medical Image Storage Device (LMB, NFF)
892.2020Medical Image Communications Device (NFG, LMD)
892.2050Picture Archiving and Communications System(QIH, OMJ, NWE, PGY, OEB, QKB, PZO, NFJ, LLZ) 

The goal of the update is that they no longer include software functions that are excluded from the device definition by section 520(o)(1) of the FD&C Act and thus are not subject to FDA’s device statutory authority.

This includes software functions that are solely intended to transfer, store, convert formats, or display, unless such functions are intended to interpret or analyze clinical laboratory test or other device data, results, and findings.

The respective classification regulations are going to be changed when the final rule is published and legally binding on April 19, 2021.


Australia

Clinical Evidence Guideline

The Australian TGA has issued a Guideline on Clinical Evidence, which is aimed at manufacturers of both medical devices and in vitro diagnostic products.

The document is divided into two parts: Part 1 contains general information on clinical evidence of safety and performance and explains the associated 15 TGA "Essential Principles" applicable to IVDs. Part 2 bundles information on the same topic for six specific types of medical devices. These are, for example, prosthetic joints or implantable pulse generators. The guideline can be found under the following link:


Malaysia

Medical Device Advertisement Approval

Malaysian laws contain sections that regulate the correct application of medical devices. For example, the specific requirements can be found in Section 44 of the Medical Device Act 2012.

The just issued Guidance from the Malaysian MDA deals with exactly this topic and describes the procedure for obtaining permission to advertise medical devices in Malaysia. The full document can be found here:


Medical Device Code of Advertisement

Another MDA document takes the same line: if permission is obtained to advertise medical technology products, a number of rules must be observed. For example, a special notice must be used for advertising aimed at children.

These and many other points can be found in a guidance that has just been updated. Also of interest are the paragraphs that must be observed when advertising with healthcare professionals or user testimonials. The entire code can be read at the following link:


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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.