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Certificate of Free Sale (CFS) for Medical Devices

A Certificate of Free Sale (CFS), sometimes called Free Sale Certificate (FSC) is issued by a Competent Authority, such as the MHRA in the UK or the MCCAA in Malta.

In territories outside the EU there seems to be confusion regarding who issues a Certificate of Free Sale, in this short article we will attempt to shine a light on this process.

Each member state of the EU has a Competent Authority (CA), and it is the member state where your EU Authorised Representative is located that determines the issuing CA. Advena are based in two EU locations the UK and Malta, therefore we can obtain a CFS from the MHRA or the MCCAA.

A CFS certifies that a medical device has been CE marked (CE marking) under one of the medical device directives and is available for free sale with the EU/EEA.

There are many non-EU/EEA countries who require as supporting documents for local market authorisation a CFS issued by a Competent Authority. Advena when appointed as a manufacturers EC Rep are able to provide this important documentation.

In many cases a Certificate of Free Sale must also be apostilled by the Ministry of Health/Foreign Affairs office and attested by a countries Embassy/Consulate, again Advena are able to facilitate this requirement.

For further information please contact our administration team at info@advenamedical.com

Breaking News! Intertek/AMTAC

It would seem Intertek have sent out co-ordinated information regarding their future certification activities, we have now heard from multiple sources and can confirm the following important information:

Intertek has chosen to centralise its Notified Body activities to Intertek Semko AB (NB No 0413) in Kista, Sweden (SEMKO). This will lead to the closure of AMTAC, which is anticipated to take effect on 1 July 2018.

Given that many clients have experienced a less than satisfactory service from Intertek over the last 12-18 months we’re sure many of you will exercise extreme caution when considering your next steps, our advice is, whatever your decision, act now! Do not delay! And if you need our help, please do contact us.

More on this will undoubtedly follow in our next newsletter!

Meet Advena at Arab Health 2018

Advena will be located in Hall 7, Stand H7C50 at this important show in Dubai from 29th January to 1st February 2018.

We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would like to meet one of our team to contact Anthony Kirby (Anthony.kirby@advenamedical.com) well in advance as the meeting room needs to be booked for any extended conversations or product reviews.

If you are planning to visit Advena at Arab Health please order your visitor pass now to secure your free pass and avoid the on-site registration fee. To register visit www.arabhealthonline.com/rsvp.

Further details about Arab Health 2018 may be found at https://www.arabhealthonline.com/en/Home.html

Anthony Kirby
Director of Business Services
Kenneth Shaw
Regulatory Associate

Due to Continued Growth Advena are Seeking to Employ Another Senior Regulatory Consultant.

Job description

Role Title

Senior Regulatory Consultant – Medical Devices

Location

Office Based in Warwick, United Kingdom

Rewards

Competitive salary.

About Us

Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office in Malta. 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 products.

Summary

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

As a key member of this team you will in essence manage your own work-load 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 would allow you to use your regulatory expertise to help develop our worldwide client base, in particular in 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, 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 it would be beneficial to have 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
  • 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
  • Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820, Canadian ISO 13485 into quality management systems from inception and to upgrade existing systems and knowledge of MDSAP.
  • 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 Senior 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.

Applications must be submitted by Thursday 30th November 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 4th December 2017.

Please note we are currently not accepting applications via agencies.

Job

Regulatory/QMS.

Primary Location

Warwick, United Kingdom.

Schedule

Full-time.

An Exciting Career Opportunity With Advena Limited

Job description

Role Title

Regulatory Associate – Medical Devices

Location

Office Based in Warwick, United Kingdom

Rewards

Competitive salary.

About Us

Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office in Malta. 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 products.

Summary

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

As 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 would allow you to use your regulatory expertise to help develop our worldwide client base, in particular in 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, in the capacity of a regulatory associate, 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

  • 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 Thursday 30th November 2017, for those selected for an initial interview, these are currently planned to be held week commencing the 4th December 2017.

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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