Sushvin Consultancy Services - Medical Devices Industry Updates - Newsletter December 2023
Sushvin Consultancy Services
QA/RA Medical Device Consultancy - QMS - MDR -IVDR- ISO 13485 -SaMD- CE Marking - Global registrations- UKRP-UKCA
Sushvin Consultancy Services has undertaken an initiative to start a monthly newsletter since April 2023 to provide latest updates from pharmaceutical and medical devices industry.?
This will enable us to educate industry participants of latest happening, changes or updates to standards, guidance and regulations. As a part of this initiative, this month’s newsletter will cover updates from medical devices industry for the month of December 2023.
There have been few updates in the month of December 2023. These are as follows:
Open until 31 December 2023
ISO Technical Committee 210/Working Group 1 (ISO/TC 210/WG 1) is responsible for developing ISO 13485. The most recent published edition is ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes.
The intent of this survey is to gather stakeholder feedback on the existing use of the standard for regulatory purposes. With the current regulatory environment for medical devices, ISO/TC 210/WG 1 needs to gauge stakeholder needs and determine the benefits or negative impacts of a possible revision. In addition, ISO/TC 210/WG 1 needs to understand the stakeholder experience and evaluate any proposed revisions against global regulatory models. If a revision is necessary, the survey data will help guide ISO/TC 210/WG 1 in the creation of new design specifications.
The survey is expected to take no longer than 10-20 minutes to complete. Participants have the option to respond to only Sections 1 and 2 if desired. The three sections of the survey are as follows:
-?????Section 1 is intended to collect basic organization and participant demographics,
-?????Section 2 asks questions about an organization’s MSS use and HAMSS impact, and
-???? Section 3 provides participants a place to provide specific feedback by clause for ISO/TC 210/WG 1 to consider, should a revision of ISO 13485 be necessary.
UK Updates?
UKABs carry out medical device conformity assessments under the UKCA scheme. The scheme allows manufacturers to market their products in the UK. TüV SüD’s UKAB designation will help ease market pressure, at a time when industry is concerned by the limited capacity to conduct UKCA medical device conformity assessments within specified government deadlines. TüV SüD’s UKAB accreditation also offers medical device manufacturers the chance to gain UKCA and CE certification simultaneously which can reduce costs and time to market across Europe for new products.
Monisha Phillips, Head of UK Medical and Health Services (MHS) Certification Body at TüV SüD, said: “Extending our designation scope to include active implantable medical devices mirrors TüV SüD Germany’s EU Notified Body scope and will allow our active implantable medical devices clients to benefit from our full support for EU and UK market access, so they can optimise efficiencies.”
TüV SüD is now a designated UKAB for Part III of the UK Medical Devices Regulations 2002 (SI 618, as amended) for Active Implantable Medical Devices.
Full details of the scope of designation can be accessed here: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies
New streamlined notification scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation
UK patients, the healthcare system and the life sciences sector are set to benefit from a new scheme that will see the time taken by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the lowest-risk clinical trials reduced by more than 50%.
Initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated.
About 20% of UK initial clinical trial applications are expected to be eligible for the scheme. Applications for clinical trial amendments will not be eligible.
Clinical trials for medicines: apply for authorisation in the UK
-????????? Added information about the New Notification Scheme criteria
-????????? Added document 'Tabular Summary input (template) for non marked IVD devices'.
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.?
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
EU Updates
This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.
Article 15 of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces the new role of a person responsible for regulatory compliance (PRRC), and the obligation for a manufacturer and authorised representative to have such a person at their disposal. This new role is intended to ensure that the supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance, who fulfils the minimum conditions of qualification for the role.
The appointment of a PRRC is applicable for manufacturers, whether established inside or outside the EU, placing devices on the Union Market and authorised representatives of non-EU manufacturers. The term ‘device’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices, accessories for in vitro diagnostic medical devices and also, custom-made devices . References to ‘the Regulations’ should be understood to cover both the MDR and IVDR.
This document provides guidance on the roles and obligations of the PRRC and is addressed to manufacturers, authorised representatives and PRRCs.
Alongside this the MDCG has updated "MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746"
This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices. References to ‘the Regulations’ should be understood to cover both the MDR and IVDR.
The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. Activities described in Article 16 of the Regulations are covered in other guidance documents, including MDCG 2018-6, MDCG 2021-23 and MDCG 2021-26.
Note: This document is non-exhaustive and should be read in conjunction with the MDR/IVDR. Of additional relevance are the Regulation (EU) 2019/1020 on market surveillance where applicable to the MDR and IVDR, the horizontal guidelines of the European Commission’s ‘Blue Guide’ based on the principles of the New Legislative Framework, and further complementary medical devices sectorial guidance documents.
A recently approved position paper from the European Association of Medical Devices Notified Bodies — referred to as Team-NB — addresses the question “What should ‘lifetime’ mean in guidelines when referring to the lifespan of medical devices?”
The paper aims to:
- Create a common understanding of the term ‘medical device lifetime’
- To “…promote consistency in approach…and…”to provide an overview of existing guidance and standards”
- Illustrate (generally) how manufacturers may determine a device’s lifetime for active, software (MDSW), implantable, and biological devices
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- Further, set expectations on what manufacturers are expected to consider and manage, as part of the device lifetime planning
- Identify the relationship between medical device lifetime and clinical data requirements
- Provide a brief overview of statistical analysis methods
- Provide Team Notified Body’s recommendations to manufacturers
Recommendations from Team NB:
- Manufacturers are expected to define the time period for lifetime or expected lifetime or service lifetime in the technical documentation and the instructions for use.
- “Unlimited lifetime or undefined lifetime is practically impossible to claim” and “lifetime is expected to be defined in quantitative terms of number of years, number/intensity of uses, or operational period.
- Device lifetime should be part of design inputs where possible, and include testing and acceptance criteria as part of design outputs. It should be clear how each element determining the device’s lifetime was verified, with supporting evidence for normal conditions of use.
- Clinical data can be used for supportive evidence of a device’s lifetime, e.g., from post-market surveillance. The device’s positive benefit-risk profile must be maintained throughout its lifetime.
- “Where there is no clinical study data available, data from literature, or whether a PMCF study is required, as well as applicable device characteristics and pre-clinical performance evaluation…could be considered”.
- Manufacturers may provide justifications for their device testing and analysis methods. However, “any such justification should correspond to reasonable risk of severity and likelihood of failure modes for the device and SOTA [state of the art] irrespective of procedures, and take into consideration how long the device is reasonably likely to be safe and effective for use and of the duration in the body (where applicable) to decommission.”
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This guidance document provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the MDR. It also provides explanations and examples for the application of certain classification rules to products without an intended medical purpose, hereinafter also referred to as devices.
The examples provided do not imply that the products are a priori qualified as devices. Classification rules apply after the qualification of the product as a device has been established.
This guidance document should be used in conjunction with the MDCG 2021-24 on classification of medical devices and take into consideration Commission Implementing Regulation (EU) 2022/2347 on reclassification.
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the CS. For dual-purpose devices, which are devices with a medical and a non-medical intended purpose, this guidance applies only to the non-medical intended purpose.
This guidance document should be used in conjunction with MDCG 2020-5 on equivalence.
MedTech Europe is a European trade association for the medical technology industry, which includes diagnostics, medical devices, and digital health. The medical technology industry offers more than 500,000 products, services, and solutions, including bandages, blood tests, hearing aids, cancer screening tests, pacemakers, and glucose monitors.
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening, and b) those related to management of lifethreatening infectious diseases. Under the In vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR), Class D devices rely on a complex infrastructure whose elements must work together: Common Specifications, Expert Panel assessment, Notified Body review, and evaluation by EU Reference Laboratories. MedTech Europe has always supported the full and early establishment of all needed infrastructure for Class D devices.
With the deadline to certify Class D devices under the IVDR arriving in only 18 months from now (26 May 2025), manufacturers wishing to transition their devices face numerous challenges in the regulatory pathway.
With this paper, MedTech Europe makes several recommendations to ensure the continuous supply of Class D devices from the transition date of 26 May 2025.
This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). This document may be supplemented in due course with further questions and answers.
While clinical investigation is clearly defined in the MDR, it is sometimes also necessary to mention that there are studies that do not fulfil this definition, to draw the line between when the provisions in the MDR chapter VI and annex XV apply, and when they don’t. For this purpose, the broader term “clinical study” is used, and covers, for the purpose of this guidance, studies done within medical research involving humans and includes clinical trials of medicines, clinical investigations of devices, and clinical performance studies of in vitro diagnostic devices, as well as other studies in a clinical setting where products such as drugs or devices are not necessarily involved at all.
Further, the sponsor needs to be aware that MDR does not specify details about ethics review of clinical investigations. It is thus necessary to check national requirements in relation to submission to the Ethics Committee and if applicable, make sure that Ethics Committees and Competent Authorities have access to the same versions of updated documents.
This is an important update for all legacy class D devices in IVDR,
New IVDR manufacturers EU reference labs are going to increase the timelines for certification.
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.?
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
Canada Updates
Medical device establishment licence application form (FRM-0292): Application checklist
Swissmedic, Switzerland Updates
The guidance applies to:
-?????optical frames, which are considered as class I medical device according to the MedDO.
-?????frames for sunglasses and safety eyewear, fitted with prescription lenses for vision correction which are considered as class I medical device according to the MedDO.
Note: Though the primary mode of action for such frames is personal protection, the device is subject to both the applicable regulatory requirements of MedDO and PSAV, unless specifically excluded.
This guidance applies to both frames and prescription lenses, which are also considered as medical devices. This guidance does not apply to safety eyewear as they do not allow any repair as per Personal Protective Equipment Regulation (PSAV).
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.?
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.