January Newsletter – EU Regulations

MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic medical devices | 12 January 2022

This notice is addressed to manufacturers of In-Vitro Diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection1 who are based in countries outside the EU or the EEA and who place or intend to place the abovementioned devices on the EU market.

It is intended to highlight a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding the compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.

These issues can also be relevant for SARS-CoV-2 devices which are transitioning to Regulation (EU) 2017/746.

Link : mdcg_2022-1_en.pdf

Presentations and recording- Webinar: “Regulatory possibilities to enhance cooperation among the EU’s government structures and complementarity within the EU acquis” | 11 January 2022

This webinar revolved around the EU regulatory possibilities in the field of health for developing an inclusive and equitable EU pharmaceutical strategy.

Starting from the role of the European Commission, particularly of DG Santé in building cooperation among EU agencies (including the future HERA) and other parts of the European Commission more centrally in the EU’s governance structures, this webinar discussed the EU dynamics in approaching health and problematising health issues, notably in the context of the pandemic and vaccine strategy.

It also considered the question of the EU’s competence and its potential, be it with or without Treaty revision, both from an internal perspective within the EU, but also from an external/global perspective of how the EU can promote equitable access to pharmaceuticals in less economically developed countries outside the EU.

A few specific examples of these regulatory challenges will be explored in more detail in order to evaluate the complementarity and interoperability of the EU’s legal framework (‘acquis’) on medicines with, for instance, the one applicable to patents, or the one applicable to genetically modified organisms.

Link: policy_20220111_hpp-news_en.pdf

Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the member states in safety assessment of clinical trials | 10 January 2022

Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the Member States in the safety assessment of clinical trials


Consultation: Fees and Charges Proposal 2022-23| 25 January 2022

The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year.

Specifically, we are seeking feedback on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes.

The TGA within the Department of Health is responsible for the supply, import, export, manufacturing and advertising of therapeutic goods. The TGA recovers its costs from the industry in accordance with the Australian Government Charging Framework.

The Therapeutic Goods Act 1989 provides the legal authority for the TGA to charge for its regulatory activities. The Therapeutic Goods Act 1989  provides the legal authority to levy annual charges on sponsors and manufacturers of medicines, biologicals and medical devices.

COVID-19 rapid antigen tests – information for manufacturers and sponsors| 24 January 2022

All COVID-19 test kits must be approved for inclusion in the Australian Register of Therapeutic Goods (ARTG), in order to be legally supplied in Australia. One exception to this is for Class 4 in-house IVDs being used to perform donor screening under the emergency exemption.

All importers of COVID-19 test kits must apply for, and be granted, an import permit for all consignments of COVID-19 test kits that are imported into Australia, unless the importer can demonstrate that the goods are for personal use only or, for lateral flow test kits, meet the import conditions published on the Australian Biosecurity Import Conditions (BICON).

The Department of Agriculture, Water and the Environment has published a new web page providing information about the import of COVID-19 Rapid Antigen Test Kits for both commercial and personal use.

To minimise price gouging and limit exportation of COVID-19 rapid antigen tests, an emergency determination(link is external) under section 477 of the Biosecurity Act 2015  was made.

The determination also outlines the enforcement of price gouging and exceptions for exporting COVID-19 rapid antigen tests.

Advisory Committee on Medical Device (ACMD)| 19 January 2022

The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, performance and manufacturing of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post-market monitoring.

The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990. Members are appointed by the Minister. Membership is comprised of professionals with specific scientific, medical, and clinical expertise as well as appropriate consumer health issues relating to medical devices.

On 1 January 2017, functions of the Advisory Committee on the Safety of Medical Devices (ACSMD) were consolidated into ACMD to encompass pre and post-market advice for medical devices.

Limitations of pulse oximeters and the effect of skin pigmentation| 07 January 2022

COVID-19 has caused an increase in pulse oximeters being used to help estimate blood oxygen levels and therefore assist in monitoring a person with COVID-19 infection.

Recent reports have highlighted that multiple factors, including skin pigmentation, can impact the accuracy of pulse oximeters. Overreliance on pulse oximeters could lead to suboptimal management of patients whose oxygen levels are below normal.

This risk is higher in persons with darker skin.


Assessing the credibility of Computational Modelling and Simulation in Medical Device Submissions- Draft Guidance for Industry and Food and Drug Administration Staff| 27 January 2022

This draft guidance document provides the FDA’s recommendations on a risk-based framework that can be used in the credibility assessment of computational modelling and simulation (CM&S) used in medical device regulatory submissions.

This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.

Credibility of Computational Models program: Research on Computational Models and Simulation Associated with Medical Devices| 27 January 2022

The FDA is extending the comment period  on the document published on December 23, 2022 (86 FR 72969) by 30 days. Submit either electronic or written comments on the draft guidance by March 24, 2022.

On December 23, 2021, the FDA issued the draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.

This draft guidance will be open for public comments at www.Regulations.gov under docket number FDA-2021-D-0980. The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modelling and Simulation (CM&S) used in medical device regulatory submissions.

This draft guidance, when finalized, is intended to help improve the consistency and transparency of the review of CM&S evidence, to increase confidence in the use of this evidence in regulatory submissions, and to facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff.

This draft guidance is not for implementation.

Medical Device Types to Help Determine Section 506J Notification Obligations|14 January 2022

This table is part of  notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.

This table represents the FDA’s recommendations based on its current understanding of the device types and corresponding product codes that manufacturers should consider to determine whether they are required to notify FDA under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) during the COVID-19 pandemic.

This table is not exhaustive, and FDA intends to update this table as the COVID-19 pandemic evolves.

Device TypesExamplesProduct Code(s)
Clinical Chemistry ProductsCritical Care Tests, Tests That May Monitor COVID-19 ProgressionCEM, CEO, CFA, CGL, CGX, CGZ, CHL, CIC, CJY, JFL, JGJ, JGS, KHP, KHS, LFR, NBW, PZI, CGR, CIG, CIT, CIX, CJE, JFM, JFT
Dialysis-Related ProductsDialysis Accessories, DialyzersFID, PQK, FIG, FIR, FJD, FJF, FJI, FJK, FJT, FKB, FKJ, FKO, FKR, FLA, KDJ, KDL, KDN, KOC, KPF, KPO, LFK, LLB, MLW, MPB, MQS, MSD, MSY, NQJ, NYU, PEH, PFH, PKI, PPJ, FIL, FKP, FKQ, KDI
General ICU/Hospital ProductsAir Purifiers, Beds, Cleaning Products, Feeding Tubes, GI CathetersFRA, FRF, FNJ, FNK, FNL, FPO, KMG, MDZ, MEC, PSB, PSC, KGC, KNT, BSS, PIF, EZL, EOQ, KTI, PSV, FKK, KOD, FRR, LGM, LGN, PEZ, PWQ, FMK, NGT
Hematology ProductsOxygenation Tests, Clotting TestsDAP, GJS, GKR, JKS, JPA, MVU
Infusion Pumps and Related AccessoriesInfusion Pump Accessories, PumpsFMG, FOX, FOZ, FPA, FPB, FPK, KPE, KZD, LDR, LJS, LJT, MJF, MRZ, OJA, PND, PTI, FRN, MEA
Microbiology ProductsFlu Assay and MediaDCK, OEP, OTG, OZE, PSZ, QDS, QKP
Needles and SyringesN/AFMF, FMI, MEG, MMK
Personal Protective Equipment (PPE)Gloves, Gowns and Surgical Apparel, Respirators, Surgical MasksFMC, KGO, LYY, LYZ, LZA, LZB, LZC, OCP, OIG, OPA, OPC, OPI, PXC, QDO, IWP, OXZ, FME, FXO, FXP, FXY, FXZ, FYA, FYB, FYC, LYU, OEA, BWP, FXW, FYE, FYF, MSH, NZJ, ONT, ORW, FXX, OUK
Sterilization ProductsEtO, Steam, Sterilization AccessoriesFLF, FLI, MLR, FLE, KCT, MED
Testing Supplies and EquipmentGeneric Analyzer, Reagents, Specimen Container, Specimen Collection, Transport Media, Swabs, VialsPFF, PPM, PFT, KDT, KDW, LIO, JSM, JSL, JSN, JTW, JTX, JSG, CBD, KXG, JKA, OYJ, QBD, QOF, JJH, JQW, KHO, LXG, NSU, OOI, JRC, GIM

Medical device Material Safety Summaries: ECRI Reports| 11 January 2022

The U.S. Food and Drug Administration (FDA) partnered with ECRI (originally founded as Emergency Care Research Institute), an independent non-profit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. 

As part of the FDA’s ongoing commitment to promote the safety of medical devices, the FDA and ECRI are publishing these safety summaries for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time.

Federal Register: Permanent Discontinuance or Interruption in manufacturing of a Device under the Federal food, Drug, and Cosmetic Act| 10 January 2022

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.”

The Federal Food, Drug, and Cosmetic Act (FD&C Act) require manufacturers to notify the FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in the supply of that device in the United States.

This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices during or in advance of a public health emergency.

FDA is issuing this guidance to implement amendments to the FD&C Act by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to devise shortages and potential device shortages during or in advance of a public health emergency.

This draft guidance is not final nor is it in effect at this time.

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act- Draft Guidance for Industry and Staff|10 January 2022

The Food and Drug Administration (FDA or Agency) is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to notifying FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency.


Notify the MHRA about a clinical investigation for a medical device| 17 January 2022

You may need to carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.

Regulating Medical Devices in the UK| 1 January 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including:

  • getting your device certified
  • conformity marking your device
  • registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.

Register Medical Device to place on the market| 1 January 2022

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).

In Great, Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be placed on the market and registered with the MHRA.

New proposals for the future of UK clinical trial legislation| 17 January 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public consultation on a set of far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. Clinical trials are vitally important for achieving advances in medical treatment.

Clinical trials may be conducted for a range of purposes, for example to test whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines – as has been seen with the rapid introduction of new vaccines and therapeutics for COVID-19.


European Commission public consultation: Product with an aesthetic or non-medical purpose- safety requirements| 19 January 2022

The European Commission has published a draft of the common specifications for products with an aesthetic or non-medical purpose listed in Annex XVI of Regulation (EU) 2017/745. Feedback can be submitted during a period of public consultation, which will remain open until 11 February 2022.

The draft document sets out general requirements relating to risk management and information for safety, as well as specific requirements relating to contact lenses, implants, fillers, body sculpting equipment, body hair removal devices and electrical brain stimulators.


Obligations for authorised representatives, importers and distributors | 06 January 2022

The Medical Devices Ordinance (MedDO; SR 812.213) sets out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 335 kB, 30.12.2021)

Good Practice for the reprocessing of medical device for Swiss health facilities| 04 January 2022

Publication of the “Good practice for the reprocessing of medical devices for Swiss health facilities” (GPA), version 2022.

The legal requirements pertaining to reprocessing are set out in Art. 72 of the Medical Devices Ordinance (MedDO). Medical devices intended for multiple use or single-use that are not supplied in sterile condition must be reprocessed before use in accordance to the current state of technology and science, taking account of the manufacturer’s instructions and the requirements of good hygiene. 

Suitable methods must be used for reprocessing, which generally comprises cleaning, disinfection, functional inspection, packing, sterilisation, transport and storage.

These methods must have been validated in accordance with the state of technology and science, and their efficacy must have been demonstrated and be transparently and reproducibly guaranteed within the framework of an appropriate quality management system.


Safety Notices for Medical Devices- December 2021 | 18 January 2022

The Safety Corrective Notice is a written notification from the manufacturer or authorized representative of the medical device manufacturer of the safety corrective measures that need to be put in place to ensure that the devices are safe to use and thus reduce the risk of adverse events.

The manufacturer of the medical device or the manufacturer’s authorized representative must inform both the JAZMP and the users of the medical device in writing of the safety corrective measures, and the manufacturer must ensure that all users are informed immediately.


Medical devices: Anvisa provided new subject code for data submission| 10 January 2022

Anvisa informs that, as of this Monday (1/10), the sending of information on technical attributes of medical devices selected for economic monitoring by the Agency must be carried out exclusively through the Request System, by subject code 80285 – G ecor – Submission of technical attributes of medical devices (health products).   

It is noteworthy that the measure is in accordance with the  Resolution of the Collegiate Board (RDC) 478/2021 , which provides for the economic monitoring of medical devices. The new subject code was created in compliance with article 21 of the standard.   

According to the Resolution, companies that hold the registration of monitored medical devices must use the new subject code to send technical attribute information in the following situations :  

  • when a new registration is granted, within 60 days after publication;  
  • at the time of revalidation of the registration; and whenever post-registration changes are made that include new models, change or include information related to the technical attributes of the medical device, within a period of up to 60 days after the post-registration change is granted.   


Latest information about clinical trials information system (CITS) | 17 January 2022

In the context of the new Clinical Trials Regulation an informative presentation on Clinical Trials Information System (CTIS) has been prepared and is available here. CTIS will be the single entry point for submitting clinical trial information in the EU and the European Economic Area (EEA).