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UKCA: UK’s Proposed ‘CE Mark’ Replacement

In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on the EU market and that the UKCA mark will need to be applied in the following situation(s);

  • The product is for the UK market.
  • The product requires mandatory third-party conformity assessment.
  • The conformity assessment for the product has been carried out by a UK conformity assessment body (a UK-based notified body or recognised third-party organisations).

The guidance also stipulates that “in the majority of cases you will still be able to use the CE marking if you are selling goods on the UK market after the UK leaves the EU. The CE marking will only be accepted in the UK for a limited time after Brexit”, however, this guidance was withdrawn on 30th January 2020.

With the deadline for the end of the 1-year transition period fast approaching, it is still unclear whether the UK government intends to put these measures in place. As a result, manufacturers are urging the UK government to provide more details and guidance on these plans to ensure they have adequate time to prepare to affix the UKCA mark on their products.

It is understood that the UK government is not likely to announce details of the new UKCA mark until a mutual decision has been made as part of the ongoing UK-EU trade negotiations. Understandably, concerns are growing as to the relatively short time left to put any new UK requirements in place to ensure compliance before the end of the year, although we have been made aware from a reliable source that the MHRA is currently reviewing the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

We will keep you posted with any updates as soon as we receive them.

An Exciting Career Opportunity With Advena Limited in Malta

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

Role/Title:

Regulatory Associate – Medical Devices

Location:

Office Based in Swatar, Malta

Rewards:

Competitive salary.

About Us:

Advena Limited is essentially two companies; Advena Limited in the UK and Advena Limited in Malta. Both companies are expanding medical device consultancy business, the UK business primarily has a client base from within the EU (including the UK), while our office in Malta has a client base who are located outside the EU. As a group we specialise in supporting small to medium sized medical device manufacturers and start-ups, to achieve regulatory compliance and CE Mark their medical device products.

In Summary

This is an exciting time to join Advena, in this intermediate but crucial role within our small team of regulatory specialists, to primarily work on assisting with the preparation of technical documentation and files for submission for audit by Notified Bodies. However, there are also business administration duties, including our quality management system, that must be carried out that underpin our activities.

As Regulatory Associate, you will be an integral member of our team you will be guided by senior team members, providing you with the requisite support and guidance, enabling you to 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 requirements for medical devices and IVD’s.
  • Providing on-going regulatory advice and guidance to all clients.
  • 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 (Regulatory Associate)

  • Some regulatory experience with a medical devices background is preferred. However this role would suit a university graduate, majoring in bio-mechanical engineering.
  • You will preferably have some experience with the requirements of medical device Class I, IIa, IIb and III technical documentation.
  • 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
  • Risk analysis & risk management activities to ISO 14971 and FDA
  • Implementation of various standards and directives relevant to compliance to EU Medical Device Directive 93/42/EC and ISO 13485
  • 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 have a keen interest in technical documentation and in medical devices and would be interested in a career as a regulatory associate, with the long term goal of becoming a consultant and can demonstrate an understanding of the criteria outlined here, we would love to hear from you.

Applications must be submitted by 31st August 2020 for those selected for an initial interview, these are currently planned to be held during September 2020.

Please note we are currently not accepting applications via agencies.

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

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