European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021
The European Commission (MDCG) published a question and answers article for European Medical Device Nomenclature (EMDN). European Medical Device Nomenclature (EMDN) supports the functioning of the European database (EUDAMED). EMDN will be used for the registration of medical devices in EUDAMED by manufacturers. It explains the term EMDN, how EMDN is created, its key principles, the structure of EMDN.
MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | 23 June 2021
The document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.
Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 7 June 2021
European commission has issued a plan for implementation of in vitro diagnostic medical devices regulation (EU) 2017/746. This plan serves as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.
UK MHRA
Operation Pangea: Officers from the Medicines and Healthcare products Regulatory Agency (MHRA) have seized millions of illegally traded medicines and medical devices | 8 June 2021
In a week of action coordinated by Interpol, this year’s ‘Operation Pangea’ ran from 18 to 25 May and saw over 100 countries joining forces to seize non-compliant medical products and to identify and remove thousands of illegally operating websites and URLs offering medicines and devices. The operation also involved coordinating the arrests of several suspected organized criminals. The MHRA will be following the week of action with a detailed analysis of the global results to create a better understanding of current and emerging threats. This work includes the identification of ‘hotspot’ exporting countries, favoured high-risk medicines being traded on the black market, and the ever-evolving business models of criminals worldwide seeking to take advantage of the public.
US FDA
Clinical Outcome Assessments (COAs) in Medical Device Decision Making | 21 June 2021
A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer, through performance of an activity or task or by the patient. For regulatory purposes, high-quality information from COAs can provide valuable evidence for benefit-risk assessments and can be used in medical device labeling to communicate the effect of a treatment on patient symptoms and functioning. COAs may also be used to help measure the safety of the device and measure how well the device performs in treating or diagnosing the condition.
HEALTH CANADA
Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach | 15 June 2021
There are currently various technologies to detect SARS CoV-2, the virus that causes COVID-19. While some rapid antigen detection tests (RADTs) have been approved for people without symptoms,
most RADTs are indicated for use on people with symptoms and are to be conducted by laboratory personnel, healthcare professionals or trained operators. Health Canada has authorized several RADTs under two interim orders:
1. interim order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021)
2. interim order No. 2 for importing and selling medical devices (enacted March 1, 2021)
The interim enforcement discretion will be in effect until December 31, 2021. The exception is if :
1. Post-market monitoring identifies new risks or
2. There is no longer a need to apply this discretion based on public health status.
AUSTRALIA TGA
Custom made medical devices | 30 June 2021
On 25 February 2021, a new framework for regulating personalized medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is most devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG).
Medical device reforms: Conformity Assessment Bodies | 30 June 2021
Conformity assessment is the systematic and ongoing examination of evidence and the application of procedures to ensure a medical device complies with the essential principles for medical devices. Evidence that a device has undergone an appropriate conformity assessment procedure must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG). Previously, Australian medical device manufacturers could only apply for a conformity assessment certificate from either the TGA or an overseas Notified Body. To provide additional flexibility and timeliness, the Australian Government agreed to regulatory changes that allow other Australian corporations that demonstrate appropriate experience and competence to undertake conformity assessment of medical devices. An Australian CAB must demonstrate they can perform product assessments and quality management system audits under the Australian conformity assessment body framework. The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG).
Regulatory changes for custom-made medical devices | 21 June 2021
On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted to meet the needs of an individual. The changes are collectively referred to as the personalized medical devices framework (the Framework). The Framework introduced the following:
On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted to meet the needs of an individual. The changes are collectively referred to as the personalized medical devices framework (the Framework). The Framework introduced the following:
New definitions for types of personalized medical devices, greatly reducing the number of devices that can be supplied under the custom-made medical device exemption.
New conditions of exemption for custom-made medical devices, in the form of requirements to: • submit an annual report detailing all custom-made medical devices supplied in the previous financial year. • Allow the TGA to inspect production facilities. • retain documentation about custom-made medical devices for 5 years (for Non implantable devices) or 15 years (for implantable devices). • Provide information about each custom-made medical device to the intended recipient.
The new concept of a Medical Device Production System (MDPS) which, once fully implemented, will provide options to healthcare providers wishing to produce personalized devices for treating their patients and updates to the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purposes of recording patient anatomy for diagnosis and investigation, including anatomical models.
SINGAPORE HSA
Mean applicant screening response time | 23 June 2021
HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of 01 Oct 2020 to 31 Mar 2021, the mean screening time taken by HSA was 31.9 Working Days (WD) for New Drug Application (NDA), 33.6 WD for Generic Drug Application (GDA) and 19.2 WD for Major Application Variation (MAV) applications, respectively.
Below are bi-annual updates of the mean applicant response time for the new and major variation applications:
Mean Applicant Response Time
Period
NDA
GDA
MAV
01 Oct 2020 to 31 Mar 2021
Number of applications
62
109
79
Mean Applicant Response Time (WD)
33.2
40.2
17.0
PAKISTAN DRAP
Notification regarding amendments in form-2 of the Medical Devices Rules,2017 | 7 June 2021
The Drug Regulatory Authority of Pakistan (DRAP) on recommendation of the Medical Devices Board, made the following amendments in Form-2 sub-rule (3) of rule 63 of the Medical Devices Rules, 2017: The entries in column (2) at sub-serial number (iv) and (viii) of serial number 2 shall be omitted and remaining entries shall be renumbered accordingly.
SWITZERLAND SWISSMEDIC
Information from Swissmedic about MedDO | 19 June 2021
If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU. The transitional periods defined in Art. 104a MedDO apply to the authorized representative.
Perform market surveillance of medical devices on UK market and will be able to take decisions over the marketing and supply of device in the UK.
Responsible for designation and monitoring of UK conformity assessment bodies.
UK Approved Bodies
From 1 Jan 2021, the MHRA will be able to designate UK Medical Device Regulation approved bodies to conduct assessments for UKCA marking
Existing UK Notified Bodies with designations under the EU MDD, EU IVDD, EU AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
Manufacturers of Class I medical devices and general IVDs will be able to self-declare their conformity against Part II and Part IV of the UK MDR 2002 (in the form in which they exist on 1 January 2021), before affixing a UKCA mark and placing the device on the Great Britain market.
Class I medical devices that are sterile or have a measuring function will still require approval from an Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market.
UK Approved Notified Bodies
Update from NB’s
Manufacturers
Authorised Representatives
GB based AR not recognised in EU from 01 Jan 2021
Manufacturer based outside the EU has to appoint a AR in the EU to sell in the EU and UK based AR will not be accepted.
Importer & Distributor
If Importer is not the UK Responsible Person, the importer will be required to inform the relevant UK Responsible Person of their intention to import a device.
UK Responsible Person will be required to provide the MHRA with a list of device importers.
Existing obligations around storage, transportation and checking device labels for the CE marking or UKCA marking will continue to apply.
The importer’s name and address will not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person.
Registrations in Great Britain
After the transition period, any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.
In Great Britain, devices must conform to the UK Medical Device Regulation 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.
This will apply to devices of all classes.
Where any changes to registrations are made, a £100 standard fee will apply per application.
Registration Timeline – UK
Registration Data
• Copy of Declaration of Conformity
• E-copy of technical documentation
• Device Certificate as granted by the Notified Body
• Quality Management Certificate
• Database information Manufacturing details
• Letter of Designation
• Contact persons and list of importers
• Database information Device Details
• Database information Product Details
• Catalog/Reference (REF)
• Unique Device Identification
Responsibility of UK – Responsible Person
Device registration with MHRA before placing device in UK market.
Ensure declaration of conformity and technical documentation is present & appropriate conformity assessment procedure has been carried out
Keep a copy of the technical documentation, declaration of conformity, relevant certificate, including any amendments and supplements for inspection by the MHRA.
Provide the MHRA with all the information and documentation on request
Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
Immediately inform the manufacturer about complaints and reports about suspected incidents related to a device for which they have been designated.
Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
Labelling Requirements
As of 1 January 2021, medical devices placed on the Great Britain market will need to have either a UKCA mark or a CE mark, depending on which legislation the device has been certified under.
Where relevant, the number of the Notified Body or Approved Body will also need to appear on the label.
If you already have a valid CE mark on your device, you will not be required to re-label the device with a UKCA mark until 1 July 2023 for placement on the Great Britain market.
Devices have both marks present in labelling prior to 1 July 2023 and dual marking will be accepted on the UK market after 1 st July 2023.
From 1 Jan 2021 the name and address of the UK RP , where applicable, will need to be included on the product labelling where the UKCA mark has been fixed.
Post-market surveillance and vigilance
Once a medical device has been placed on the UK market, the manufacturer will continue to be required to submit vigilance reports to the MHRA when certain incidents occur in the UK Medical Device Regulation that involve their device.
They must also continue to take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.
Factsheet for Class I – Medical Devices | 28 April Newsletter 2021
European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5 rev. 1. for class I medical device manufacturers.
It summarizes the necessary steps to ensure the compliance of class I medical with applicable requirements of the EU-MDR 2017/745. The class I medical devices includes devices which are already placed in the market under MDD requirements and new devices expected to place on the market.
The FAQ give in factsheet helps to understand the requirements for Instruction for use and labels for class I device.
Guidance on basic UDI-DI and changes to UDI-DI MDCG 2018-1 Rev.4 | 27 April Newsletter 2021
Medical Device Coordination Group issued a Guidance on BASIC UDI-DI and changes to UDI-DI. This guidance explains the Basic UDI-DI & explain requirements of new UDI-DI for the device.
The Basic UDIDI is the primary key. It is not visible on any trade item. Basic UDI-DI is used for connecting devices with same intended purpose, risk class and essential design and manufacturing characteristics.
The new UDI-DI should be assigned to the device whenever there is a change that will lead to mislead the traceability of the device. These include changes in the following:
• Name or trade name • Device version or model • Labelled as single use • Packaged sterile • Need for sterilization before use • Quantity of devices provided in a package • Critical warnings or contra-indications (e.g. Containing latex or dehp) • CMR /endocrine disruptors.
Medical Device Coordination Group published Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation. This document is intended for clinical investigation sponsors.
The Q&A lays out the regulatory pathway for clinical investigations, also delivers guidance on difference between requirements as per EU-MDR compared to Directive 93/42/EEC and 90/385/EEC, pilot clinical investigation, responsibilities of sponsor, safety reporting requirements, modifications to clinical investigations, timeline for clinical investigations, clinical investigation reports, arrangement for the transitional period.
Guidance on standardization for medical devices MDCG 2021-5 | 16 April 2021
Guidance on standardization for medical devices by MDCG explains general framework, development, and standardization of different harmonized European standards in support of the new legislative framework if the EU for medical device.
The new EU legislative framework on medical devices consists of three current Directives and two new Regulations. The guidance also provides adequate reference list for legal and guidance framework of EU.
Commission implementing decision (EU) 2021/611 | 14 April 2021
Following standards have been included in list of harmonized standards on biological evaluation of medical devices, packaging for terminally sterilized medical devices, sterilization of health care products and clinical investigation of medical devices for human subjects:
EN ISO 10993-16:2017 EN ISO 10993-18:2020 EN ISO 11607-1:2020 EN ISO 11737-2:2020 EN ISO 14155:2020 EN ISO 11607-2:2020
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 MDCG 2021-4 | 09 April 2021
This document by Medical device coordination group includes indications for IVDR provisions for class D device related to notified body and EU reference laboratory (EURL) during transition period of EU legislation till 26 May 2022.
According to EU IVDR, in vitro medical device manufacturer needs to submit an application to notified body. As a part of conformity assessment for class D devices, whenever necessary specific elements might be reviewed by experts panel or tested in EURL.
This guidance issue helps class D IVD manufacturer.
Updated Implementation Rolling Plan – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 09 April 2021
The implementation rolling plan list down essential implementing acts and other relevant initiatives that the European commission has approved or will do so in the future.
UK MHRA
Medicines and Medical Devices Act 2021
An Act has been passed by UK government for patient safety related to human medicines and medical devices, veterinary medicines. This bill is to ensure the human safety by providing the regulations, enforcements for manufacture, marketing, and sales.
MHRA fees | 1 April 2021
The UK Government has published a new guidance to understand the changes to MHRA fees for 2021 – This guidance includes current MHRA fees for different categories of license, fees definition. These fees have come in force from 1 January 2021.
US FDA
FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview April 5 2021
Due to Covid-19 last year FDA issued Emergency Use Authorization route for the in vitro diagnostics for the detection and/or diagnosis of COVID-19 personal respiratory protective devices, and other medical devices, including alternative products used as medical devices. This list has been updated with new tests and devices.
ASCA-Accredited Testing Laboratories | 14 April 2021
The FDA announces medical device testing laboratories accredited under ASCA program.
Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures | 19 April 2021
FDA removes some software functions from medical device classification regulations to reflect the changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act).
This rule updates eight classification regulations. They do not include software functions that are excluded from the device definition by section 520(o)(1) of the FD&C Act hence does not fall under FDA’s device statutory authority.
HEALTH CANADA
Notice: Technical requirements for anti-microbial claims for medical masks | 21 April 2021
Health Canada publishes the notice for safety and effectiveness requirements for class I medical masks and face coverings with antimicrobial claims.
Face covers protecting the face from droplets or air particle without the anti-microbial claims are not considered as medical device. All new class I medical device mask with claim should support evidence and reports of necessary test for example Bacterial Filtration Efficiency (BFE).
Notice lists down total of nine safety and effectiveness requirement.
JAPAN PMDA
Digitization of package inserts | 27 April 2020
Japan PMDA issues guidance on package insert digitization requirements. Due to Pharmaceutical Machinery Act from now all the package inserts will be replaced by GS1 barcode or two-dimensional code which will contain the information regarding medical device.
This code will be scanned by PI (Package insert)-navi, A Smartphone App on phone or tablet to read the information like Emergency safety information such as package inserts, revision instruction reflection history, examination report / re-examination report, etc.
INDIA CDSCO
Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021
CDSCO India has passed an order for all implantable devices, CT scan equipment, MRI equipment, Defibrillators, PET equipment Dialysis machine, X-ray machine and bone marrow cell separator.
According to the order importers and manufacturers are required to take import/manufacturing license from the central licensing authority or state licensing authority from 1st April 2021 onwards.
AUSTRALIA TGA
TGA presentation: The regulation of medical device software | 14 April 2021
Therapeutic goods administration (TGA) of Australia has published the presentation on the regulation of medical device software on their website.
The presentation gives information on when a software can be considered as a medical devices and regulatory changes for medical device software.
CHINA NPMA
NMPA publishes guidelines for Device Master File (DMF) submissions | April 2021
National Medical Products Administration (NMPA) has released the guidance for DMF record filing requirements. It includes the necessary registration data for DMF filing application process for filing or renewal of DMF.
CMDE has announced the electronic DMF submissions using eRPS system. This announcement has included the guidance for application to become Certificate authority and format and content of DMF.
NMPA China Allows Laboratory Developed Test (LDT) | 29 April 2021
The new “Regulation for Medical Device Administration and Supervision”, Order 739 effecting from 1st June 2021 is replacing the Order 680. Article 53 in the order 739 allows the development of laboratory developed test (LDT) in China.
It allows the china medical institution to develop its own IVD reagents based on the clinical needs of the institutions. The medical institutions should meet certain criteria to produce its own IVD reagents.
Class II Medical Device Guidelines March 2021 | 16 April 2020
NMPA’s Center of Medical Device Evaluation (CMDE) and local testing centers has published the Class II medical device guidelines for 22 medical devices. This guideline instructs the renewals and new registrations process for the 22 Class II medical devices. Guidelines for devices used in Clinical Chemistry,
Orthopedic, General Hospital, Anesthesiology, Radiography, Gastroenterology / Urology has been issued.
PAKISTAN DRAP
Deployment of Pakistan Integrated Regulatory Information Management System At DRAP| 26 April 2020
Drug regulatory authority of Pakistan (DRAP) commences the use of Pakistan Integrated Regulatory Information Management System (PIRIMS) for the optimization of regulatory submission process. This digital platform will be used for new online applications of new drug manufacturing licenses (DML). The direct submission for DML will not be accepted.
