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Due to Continued Growth, Advena Limited in Malta are Looking for a Regulatory Intern.

Due to our continued expansion in Malta, Advena Limited are seeking to add a Regulatory Intern to our team of regulatory specialists, this is an exciting opportunity for an individual who has an interest in medical devices and new medical technology, we offer ‘on the job’ training to the successful applicant who over time would progress to Regulatory Associate as a steppingstone into consultancy.

We invite applications from students in their final year or those who have recently graduated.

Initial Responsibilities:

  • Gain an understanding of Regulation (EU) 2017/745 & (EU) 2017/746.
  • Basic technical documentation reviews.
  • Regulatory administration.
  • Scheduling.
  • Research.
  • 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.

Applications should be majoring in Engineering or comparable/similar disciplines.

Role Title:

Regulatory Intern – Medical Devices

Schedule:

Full-time.

Location:

Office Based in Swatar, Malta

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 entry level role that has plenty of potential, 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 Intern, 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.

Applications

If you have a keen interest in technical documentation and in medical devices and would be interested in a career in Regulatory Compliance, 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 to Mr Anthony Kirby by email to anthony.kirby@advenamedical.com including a copy of your CV. by 30th June 2021, for those selected for an initial interview, these are currently planned to be held mid-July.

The Deadline for the MDR Transition is Fast Approaching – Are You Prepared?

Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short.

Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both in the UK and Malta with a wide range of experience across the whole platform of device classifications.

Whether you need a new technical file creating or an analysis of your existing documentation and what must be done to upgrade to the MDR, we have a service that can help.

If you just need certain sections of your documentation creating or reviewing, such as Risk Management or the critically important Clinical Evaluation Report section, we can also help, or perhaps with another sections of your technical files.

Remember, you will also need to update device labelling, packaging, IFU’s etc. and while EUDAMED is not fully operational, applicable devices must be registered the competent authority where your Authorised Representative is based, there is so much to do in these remaining few months, do not delay, get in touch if you need assistance.

For further details and a quotation, Email us at: info@advenamedical.com

COVID-19| Protective Equipment

Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer.

Products that are intended to protect the patient, such as medical gloves and medical face masks, will fall under the scope of the Medical Device Directive 93/42/EEC (MDD) (to be replaced by the Medical Device Regulation 2017/745 (MDR)).

Meeting either of the above legislation will allow the manufacturer to legally affix the CE mark and circulate freely in the EU. The essential requirements of the PPE Regulation and the MDD may be met by following harmonised standards, which are published in the Official Journal of the European Union. Following this technical solution, conformity to the essential requirements may be presumed.

The following harmonised standards are applicable to face masks:

FFP-Type [PPE]             EN 149:2001+A1:2009

Medical [MD]                EN 14683:2019+AC:2019

These standards may be obtained through the following link.

The manufacturer is not required to meet all the specifications of these standards and can adopt different technical solutions. However, due to the presumption of conformity, time-to-market may be reduced drastically.

The manufacturer may decide to carry out the tests prescribed in the harmonised standards themselves or outsource this testing to a laboratory. Should the manufacturer follow these standards, the EU Competent Authorities may take a product sample and test these in accordance with the tests prescribed in the standard as part of market surveillance procedures.

Additional technical solutions and guidelines have been compiled in a list by the World Health Organisation. However, in following one of these alternative standards referred to by the WHO for PPE products, the manufacturer shall submit a sample to be tested by a designated notified body. The EU Commission has urged notified bodies to prioritise new requests for COVID-19 related PPE. In a Recommendation issued on 13 March 2020, the Commission encourages notified bodies to adopt derogations which will allow speedier market access under certain conditions.

  • Point 7 of the Recommendation allows manufacturers to anticipate the placement of their products on the market whilst the conformity assessment procedures are being finalised.
  • Point 8 of the Recommendation allows manufacturers to place their products on the market even if no conformity assessment procedures have been initiated.

Under the MDD and the MDR, medical face masks and examination gloves are considered to be class I medical devices, and as such are dependent on self-assessment and will not require notified body intervention. However, if provided in a sterile state, a notified body will be required to assess those aspects of sterility.

On the other hand, face masks and equipment used to protect against COVID-19 and are covered by the PPE Regulation are classified as Category III PPE, and thus a notified body must be involved.

In both cases, PPE and medical devices must be placed on the market with the EU/EC Declaration of Conformity document, as well as the accompanying CE Certificate issued by the notified body, when applicable. No other documents are required for market access, however, there are some additional considerations to keep in mind.

Issuing a Declaration of Conformity (DoC) signifies that you comply with that specific EU Regulation / Directive and that you have met all their requirements. Part of these requirements will be to develop and maintain a set of technical documentation.

Medical devices falling into class I, must be registered with the applicable EU Competent Authority in the country in which the manufacturer or their EU Authorised Representative is based.

For more information on how to lawfully place your PPE or medical devices on the EU market, please do not hesitate to contact us at info@advenamedical.com.

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.

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

 

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