May Newsletter

May Newsletter

EU REGULATIONS

MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers| 27 May 2021

The position paper on the implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses by MDCG provides clarification on the implementation of UDI requirements from 26 May 2021. For contact lenses, a specific UDI assignment solution is under development, and it might be extended to spectacles frames. For spectacle lenses and ready readers, a specific UDI assignment solution is agreed upon. Its practical application is yet to be finalized. Position paper also details the UDI and device registration timeline in EUDAMED.

Information notice on the status of the EU-Switzerland Mutual Recognition Agreement for Medical Devices | 26 May 2021

European commission has issued a notice to stakeholders about status of EU- Switzerland Mutual Recognition Agreement (MRA) for medical devices. MRA is one of the key agreements between the EU and Switzerland, facilitating bilateral trade for machinery, motor vehicles and medical devices. Up until 26 May 2021, medical device chapter of MRA facilitated trade of medical devices between EU and Switzerland. As the MRA is not updated following are the after-effects that stakeholders should be aware of:

• Switzerland will be treated as third world country.
• No mutual recognition of conformity assessment results in EU and Switzerland.
• Need of authorized representative in both EU and Switzerland.

Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices | 26 May 2021

European commission published the set of Q&A for application of regulation on medical devices. These Q&A explains aspects of EU-MDR like the need of new medical device rules, its benefit to the patient, safety aspects of rules, role of notified bodies, high risk devices scrutiny, rules on reprocessing single use devices & products without an intended medical purpose, EUDAMED

EU-MDR comes into force | 26 May 2021

From 26 May 2021, new EU medical device regulation (EU- MDR) comes into force, establishing robust regulatory framework for medical devices ranging hip replacements to sticking plasters. EU – MDR

improves the quality, safety and reliability of medical devices, strengthens transparency and information for patients, enhances vigilance and market surveillance.

Clinical investigation application/notification documents | 21 May 2021

MDCG published a guidance document on application to be submitted by sponsor of clinical investigation. This guidance lists down the documents which needs to be included in the application/notification to the Member state in which clinical investigation will be conducted. It includes documents such as application/notification form, supporting documents, General safety and performance requirements, standards etc. This application should be provided with documentation referred to Annex XV of EU- MDR 2017/745. The templates of the application and necessary document is also provided in the guidance.

Launch of EU UDI Helpdesk| 18 May 2021

EU UDI Helpdesk is live from 18th May 2021. The UDI system is new requirement introduced by EU-MDR for identification of medical device. The UDI Helpdesk will give support to economic operators in the UDI system implementation requirements. These requirements are assignment of UDI, labelling and registration of devices. The support will also include for the use of European Medical Devices Nomenclature (EMDN). UDI helpdesk has definitions and basic information of MDR, specific questions related to MDR, EUDAMED- related questions, various dates & deadlines of requirement, links, and documents specified by EU MDR.

Notice to manufacturers and authorized representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices | 17 May 2021

MDCG releases a notice for manufacturers & authorized representatives of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection. Notice emphasis on the duties of manufacturers to ensure the safety of the device. manufacturers should continually assess the impact of different new genetic variants on the IVD, also make sure that risk associated with the use of IVD must be accepted when it is weighed against benefits to the patients. Manufacturers also need to make sure that device conforms to essential requirement mentioned in Directive 98/79/EC on IVD. All the incident regarding devices should be reported to competent authority by manufacturer.

Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional| 04 May 2021

The revised guidance on the harmonized administrative practices and solutions until EUDAMED is fully functional includes guidelines for economic operators, competent authorities, other commissions to fulfil EU-MDR requirements related to EUDAMED. It proposes alternative solutions to submit to competent authority by responsible actors. It includes provisions such as but not limited to registration of devices, UDI system, summary of safety and clinical performance, European database on medical devices, Clinical evaluation consultation procedure for certain class III and class IIb devices. y. This guidance also foresees the launch of EUDAMED for May 2022, the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

UK MHRA 

Updated list of medical devices given exceptional use authorisations during the COVID-19 pandemic |27 May 2021

During pandemic to ensure the supply of medical devices in the UK, MHRA publishes list of manufacturers and devices that are granted exceptional use application. This list gets updated by MHRA every week. Medical devices granted an exceptional use authorisation can be sold to the NHS and within the social care.

Guidance: Notify the MHRA about a clinical investigation for a medical device| 25 May 2021

The UK Government has updated the guidance of Notifying the MHRA about a clinical investigation for a medical device. From 26th May 2021, Northern Ireland will be following EU MDR. The update includes technical details for clinical investigations in Northern Ireland. Application should be submitted to MHRA in line with the requirements of EU MDR 2017/ 745. It also provide guidance for the post market studies involving sites in Northern Ireland.

Guidance: Register medical devices to place on the market|24 May 2021

Guidance to register the medical devices with MHRA provides details regarding devices that needs to register in the UK. In this guidance, manufacturer, device, and importer attributes has been updated. The excel list of these attributes has been added in the guidance.

US FDA

FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes| 19 May 2021

The FDA issues a draft guidance for early clinical studies for devices that are intended to therapeutically improve glycemic control for type 2 diabetes. This draft recommends clinical study parameters like study design, sample size, study duration, follow up schedule, effectiveness endpoints etc. The draft guidance is issued for comment purposes only.

FDA Announces Draft Guidance to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance| 26 May 2021

FDA monitors additional data on certain devices even after FDA clearance or market approval of the device. FDA publishes two guidance documents for post market surveillance of moderate (class II) and high-risk devices (class III). This will assist manufacturers of a device to follow the FDA requirement for ongoing data collection when device is marketed. The draft guidance is issued for comment purposes only.

HEALTH CANADA

Priority COVID-19 test applications: Notice to manufacturers, importers and distributors| 7 May 2021

Health Canada issues a notice to manufacturers, importers and distributors of testing devices related to
COVID-19. The following testing technologies are on the highest priority for application evaluation by
health Canada:
• self-testing devices
• point-of-care antigen or molecular testing devices that use nasal swab or saliva samples for use in
symptomatic and asymptomatic populations administered by trained operators
• point-of-care antigen tests that do not use only nasopharyngeal (NP) swab samples, or may be used
in asymptomatic people or may be administered by trained operators
• point-of-care molecular tests that do not use only NP swab samples, or may be used in asymptomatic
people or may be administered by trained operators
• tests designed to address emerging variants
• tests that offer new or unique advantages compared to other tests of the same type

• novel diagnostic technologies that may use alternative samples, such as breath, or a different
analytical approach

Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents| 3 May 2021

Health Canada has updated 2 guidance documents to support Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. The guidance documents for medical devices is for applicants who wish to sell or import COVID-19 medical device for purpose of clinical trial or to conduct clinical trial for a COVID-19 medical devices authorized under Interim order No.2. Applicant must submit the application in the form of form to the minister.

Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice| 3 May 2021

Ministry of health approves Interim order No. 2 to support the optional pathway to facilitate clinical trials for COVID-19 drugs and medical devices. It addresses any clinical trial submissions that are outstanding when IO No. 1 expires and authorization for drugs and devices issued under IO No. 1. IO No. 2 will assist in expanding the range of applicants who will be able to apply for medical device clinical trial authorization.

Switzerland Swissmedic

New regulations applicable to medical devices as of 26 May 2021 | 26 May 2021

As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA). No barrier free access will be allowed to Switzerland manufacturers to the EU internal market. Switzerland now has been downgraded to the third country for EU. Swiss manufactures have stricter requirements when exporting their medical devices to the EU. Manufacturers outside the Swiss needs to appoint Swiss Authorised representative in Switzerland. They will need to follow. Medical Device Ordinance MedDO.

The deadline to appoint a Swiss AR is as follows:

Swiss AR deadline

AUSTRALIA TGA

Medical devices reforms: Reclassification of certain medical devices| 12 May 2021

The TGA is considering consulting regarding the proposed medical device classification for storage solutions for human cells, tissues and organs, and IVF media to simplify issues raised in submissions, prior to considering regulatory amendments for this category of devices. Their aim is to harmonize the classification rule prioritizing the patient safety.

Guidance for Declaration of Conformity| 20 May 2021

TSA released a guidance for declaration of conformity procedures for Class I non-sterile, non-measuring medical devices, Class 1 in vitro diagnostic (IVD) devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only), and Class I Systems and Procedure Packs. This guidance provides information to help manufacturers in completion of corresponding declaration of conformity and assist sponsors to confirm that all the required documentation by manufacturer is complete.

Including IVD medical devices in the ARTG| 19 May 2021

TSA has published a guidance on inclusion of IVD medical devices in the ARTG. ARTG is a register of therapeutic goods that are imported to, supplied in or exported from Australia. Sponsor in the Australia can make an application to include the IVD in the ARTG if the devices comply with the essential principles and appropriate conformity assessment procedure has been carried out. The guidance also explains the different pathways to include the various IVDs like IVD for export, Class 1 IVD, IVD other than Class 1.

Medical device inclusion process| 19 May 2021

TSA publishes the guidance for medical device inclusion process. This process is to include the medical devices in in the Australian Register of Therapeutic Goods (ARTG).  This guidance provides detailed information on steps of application to ARTG and applicable guidelines links. According to the current regulation any medical device regulated under The Therapeutic Goods Act 1989, The Therapeutic Goods (Medical Devices) Regulations 2002, The Therapeutic Goods Regulations 1990 needs to be included in the ARTG before importing, supplying, or exporting from Australia.

Therapeutic Goods (Medical Devices-Application Form for Inclusion) Approval 2021| 20 May 2021

TSA approves application forms for Class I, Class IIa, Class IIb, Class III, Class AIMD, Class 1 IVD, Class 2 IVD, Class 3 IVD, Class 4 IVD, Class 4 in house IVD devices to include in ARTG. ARTG is register of therapeutic goods in Australia.

CHINA NPMA

China to strengthen capabilities in drug administration | 10 May 2021

To better protect and promote the health of the public, the General Office of the State Council outlined efforts to enhance the country’s capabilities in drug supervision and management in a circular. Supporting laws and rules will be formulated and revised, refined normative documents and manual to be revised. The circular also emphasized efforts to improve the review and testing system for drugs and medical equipment and cosmetics, intensify the lot release capabilities and strengthen the monitoring system for adverse reactions. It urged building a national platform for drug tracing, applying big data to supervision of drugs, medical equipment, and cosmetics, and using the industrial internet in overseeing vaccines, blood products and special drugs, among others.

Singapore HSA 

Consultation for Guidance on the Medical Device Unique Device Identification (UDI) System | 25 May 2021

The Medical Devices Branch (MDB) has published a draft document “Guidance on the Medical Device Unique Device Identification (UDI) System” for comments. This document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class a Medical Device Database. The Consultation period for this document is from 25 May 2021 to 30 June 2021.

PAKISTAN DRAP

Draft Guidelines on RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS GUIDELINES| 27 May 2021

The DRAP has issued a draft guidance document applicable for both human and veterinary products with established quality defects and those reporting with safety and efficacy adverse events. These guidelines are expected to be followed by the licensees (manufacturers, importers, distributors, and retailers. These guidelines aim to explain and standardize the procedure for classification and communications involved in a product recall, to effectively remove therapeutic goods / products from the market that violate requirements and that may cause a health hazard to the consumer/user. The feedback and comments are accepted until due date 17-Jun-2021.

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