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MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

Advena Limited – Statement on COVID-19

The COVID-19 pandemic is rapidly affecting lives and how businesses operate worldwide. Increasingly governments are introducing stricter measures to protect public health, which ultimately impacts on the movement of Advena Limited’s employees’, the individuals we trust to implement our regulatory obligations.

During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority.

Advena Ltd a leading EU Authorised Representative and provider of regulatory & QMS consultancy in the medical devices industry are committed in their support of this important industry and in the part played in assisting the availability of health care products for the EU market. However, we must also comply with any restrictions applied by both the Maltese and UK governments and also implement our own COVID-19 pandemic crisis plans based on the further recommendation given, e.g. protection of employees at high-risk and working remotely, including quarantine and social distancing. These measures will undoubtedly provide challenging circumstances; however, we remain resolute in our ability to continue to meet our obligations to regulation and clients.

Therefore, while our service may experience some delays, we do not expect to suspend operations, temporarily or otherwise.

During this difficult period in our history we ask that you be patient and bear with us and above all stay safe.

Unique Device Identification (UDI) System EU2017/745 & EU2017/746

The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices.

The above is the proposed symbol to be used for medical device labelling.

UDI Anatomy

The product specific UDI is comprised of two parts: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI).

UDI-DI: This portion of the UDI is both specific to the manufacturer and device-group. This is considered to be the “access-key” to the UDI database information.

UDI-PI: This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.

Both the UDI-DI and UDI-PI may be made available in a numeric or alphanumeric code. Together, they are known as the device’s UDI which shall be displayed on the “UDI carrier”. We will discuss this later on in this article.

 

Basic UDI-DI

The Basic UDI-DI represents a device-type described as device with the same intended use, risk classification and design and manufacturing characteristics. It will be the key to device-specific information on the Eudamed database.

The Basic UDI-DI will need to be made available on specific documentation (Declaration of Conformity, Summary of Safety and Clinical Performance, Certificates) however it shall not show on the packaging or label of the device.

The Basic UDI-DI will be made up of a number of elements which shall include reference to the issuing agency, the manufacturer, the device group, and a number of check digits.

Guidance on Basic UDI-DI and changes to UDI-DI

 

Issuing Entities

In its implementing decision on 6 June 2019, the European Commission (EC) designated 4 issuing entities to operate a UDI assignment system for medical devices: (1) GS1 AISBL; (2) Health Industry Business Communications Council (HIBCC); (3) ICCBBA; and (4) Informationsstelle für Arzneispezialitäten — IFA GmbH. Each of the issuing entities use a specific coding system in accordance with their own standards; however, these coding systems are translatable to the EU Regulations requirements on UDI. E.g. GS1 have developed the term Global Model Number (GMN) for the Basic UDI-DI, Global Trade Item Number (GTIN) for UDI-DI, and Application Identifier (AI) for UDI-PI.

Commission Implementing Decision (EU) 2019/939

Come and Visit Advena at Arab Health 2020

At this year’s event both Advena Limited (UK) Advena Limited (Malta) will be represented. We will be located in Hall 2 Stand G15 within the UK pavilion, at this important show in Dubai from 27th to 30th January 2020.

Please do come and visit to discuss your medical device regulatory needs, whether this be our EU Authorised Representative service (EC REP) or our QMS & Regulatory Medical Device Consultancy services and how Brexit, the MDR or IVDR may affect your business and regulatory compliance activities.

We will be available to meet existing and prospective clients during this trade show.

We advise those who would like to meet one of our team to email for an appointment (info@advenamedical.com) well in advance to ensure we are available.

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director

Kenneth Shaw: Regulatory Consultant

If you are planning to visit Advena at Arab Health, please order your visitor pass now to secure your free pass. To register visit this link

Further details about Arab Health 2020 may be found at this link

 

An Exciting Career Opportunity With Advena Limited in the UK

Due to continued growth Advena are seeking to add to our team of regulatory specialists, we have a new position available for those who meet the criteria outlined below;

Role Title:

QMS & Medical Device Regulatory Consultant.

Location:

Office Based in Warwick, United Kingdom.

Rewards:

Competitive salary.

About Us:

Advena is essentially two companies; Advena Limited (UK) and Advena Limited (Malta), the UK business is based at our offices in Warwick. Both companies are expanding medical device consultancy businesses. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve EU and US FDA regulatory compliance.

Summary:

This is an exciting time to join Advena as a Regulatory Consultant within our small team of regulatory specialists, to primarily work on preparing technical documentation and files for submission for audit by Notified Bodies.

As a key member of our team you will manage your own workload while also providing support and guidance to the junior team members, helping them gain valuable experience to grow and develop with Advena.

This exciting opportunity will allow you to use your relevant regulatory expertise to help develop our worldwide client base, in particular guiding our clients through the transition from MDD/IVD to MDR & IVDR.

Essential Job Functions:

You may be involved in the following activities as part of your day to day responsibilities:

  • Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU or US FDA requirements for medical devices and IVD’s.
  • Providing on-going regulatory advice and guidance, in an expert capacity, to all clients and junior members of the team.
  • Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
  • Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.
  • Comply with all company policy and procedures.

 Requirements:

  • Substantial regulatory experience with a medical devices background is essential.
  • You must have substantial experience in the compilation and review of Class I, IIa, IIb and III technical documentation, in addition experience with 510k file compilation and submission to FDA.
  • You will be required to compile clinical data, post market information/data for writing up Clinical Evaluations in line with the requirements of the revised MDD Annex X, MEDDEV 2.7/1 Rev 4 and in line with the requirements of the MDR/IVDR.
  • Risk analysis & risk management activities to ISO 14971.
  • Implementation of various standards, directives, regulations relevant to compliance to EU MDD/IVD, MDR/IVDR and ISO 13485.
  • Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820 and MDSAP into quality management systems from inception and to upgrade existing systems.
  • Have good interpersonal and communication skills and be a team player.
  • Attention to detail is extremely important as is the ability to work in a fast paced exciting and deadline driven environment.

Applications:

If you are currently engaged in the activities of a Regulatory Consultant or are ready for a step up and can demonstrate you meet the criteria outlined here, we would love to hear from you.

To be considered for this exciting position, please ensure your application is submitted by Friday 20th, December 2019.

Please note we are currently not accepting applications via agencies.

Job:

Regulatory/QMS.

Primary Location:

Warwick, United Kingdom.

Schedule:

Full-time.

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