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MDR Article 120 – Transitional Provisions

On 26 May 2021, the Medical Device Regulation (EU) 2017/745 (MDR) began to apply following a 4-year transition period from the previous Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and Medical Device Directive 93/42/EEC (MDD).

The ‘Transitional Provisions’ within Article 120 of the MDR govern this switch and lay out specific derogations from the Regulation which has had a great impact on how and when medical device manufacturers transition. In fact, many manufacturers have been able to benefit from these derogations, allowing them more time to meet the requirements of the MDR.

Paragraph 2 of Article 120 focusses on the validity of certificates issued in accordance with the MDD and AIMDD prior to 25 May 2017. Certificates which have been issued before this data will remain valid until the end of their validity period, with the exception of those certificates issued in accordance with Annex 4 of the AIMDD or Annex IV of the MDD, which become void 27 May 2022. Furthermore, the validity date for AIMDD and MDD certificates issued after 25 May 2017 shall not exceed 27 May 2024. The Notified Body who has issued the AIMDD or MDD certificate will continue to be responsible for the surveillance relating to those medical devices.

 

Article 120 paragraph 3 lays out the key derogations to MDR, it states:

By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May [2021] and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May [2021] it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

 

There are several implications of this paragraph which shall be broken down below.

If a device which has been classified as class I under the MDD will now require Notified Body intervention under the new classification rules of the MDR (annex VIII), the manufacturer shall have until 26 May 2024 to meet the new requirements, provided that its MDD Declaration of Conformity was drawn up prior to 26 May 2021. Reusable surgical instruments and software are typical examples of devices which have been classified as class I under the MDD and which will now require the involvement of a Notified Body and which may benefit from the extended transitional period introduced by Article 120(3). The definition of a reusable surgical instrument is provided in Annex VIII Chapter I Section 2.3.

However, as with most good things, certain terms and conditions will apply:

  1. The device must continue to comply with the Directives from 26 May 2021.
  2. There can be no significant changes to the device design or intended purpose from 26 May 2021.
  3. The MDR requirements within the following sections shall apply from 26 May 2021:
    1. Post-Market Surveillance [Article 83-86, 92, Annex III].
    2. Market Surveillance [Article 93-100].
    3. Vigilance [Article 87-92].
    4. Registration of economic operators and devices [Article 31 and 29].

What constitutes a significant change? The EU’s Medical Device Coordination Group (MDCG) released guidance document ‘MDCG 2020-3’ which explains in some detail what is considered to be a significant change in relation to Article 120(3). The MDCG guidance provides a series of flowcharts which may be followed to determine whether the change to design or intended purpose would be considered significant or not. Such changes should always be discussed on a case-by-case basis with the relevant Notified Body, however, the following changes would not be deemed significant:

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

MDCG 2020-3

 

As a result of Article 120(3), medical devices classified as class I under the EU MDD and which will be classified as class I under the EU MDR and which are not covered by a valid CE certificate (e.g. sterile or measuring class I devices) will need to meet the requirements and obligations of the MDR from 26 May 2021. This implies that ‘simple’ class I device manufacturers will not be able to place their MDD-compliant medical devices on the EU market until they have satisfied the requirements of the MDR.

 

For manufacturers who are benefitting from the extended transition period introduced by Article 120(3), you will still need to comply with certain sections of the MDR, as specified above. The following technical documentation updates will be required as a minimum:

  • Updating the Post-Market Surveillance (PMS) Plan in accordance with Annex III.
  • Developing a PMS Report or a Periodic Safety Update Report (PSUR).
  • Updating existing procedures on vigilance to meet the requirements in Chapter VII Section 2. Of note is that ‘other’ adverse events shall be reported within 15 days rather than 30 days under the previous Directives.

These changes must be implemented within the technical documentation and QMS from 26 May 2021.

 

Article 120(3) also implies that all manufacturers placing medical devices on the EU market for the first time, will need to immediately meet the requirements and obligations as laid out in the EU MDR for their medical device.

 

How can Advena help you?

Advena has over 20 years of professional experience within the medical device industry as both a leading EU Authorised Representative and regulatory consultants. We are able to guide you through the complexities of EU regulation and help you place compliant devices on the market:

  • Regulation Gap Analysis for Directive-compliant technical documentation and QMS.
  • Regulation-compliant technical documentation.
  • Regulation-compliant QMS.
  • EU Authorised Representative service under the EU Regulations.

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.

BREXIT UPDATE! UK & Non-UK Based Medical Device Manufacturers

As many of you will now know, the Conservative & Unionist Party have elected a new leader in Boris Johnson, who has also become the UK’s new Prime Minister.

The new Prime Minister has clearly laid out his plans for the timetable of Brexit, in as much as that he and his team of cabinet ministers now speak with one voice, that the UK will leave the EU,  on or before the 31st October 2019, either with an improved deal or on a no deal basis.

The EU have stated, that they do not want the UK to leave without a deal but will not renegotiate the deal that has been offered. The UK’s new Prime Minister and his team does not accept the EU’s deal and prefers not to leave without a deal, however, and crucially are prepared to exit the EU without a deal.

This situation makes it increasingly likely that the UK will leave the EU on the 31st October 2019 without a deal.

So, what does this mean for UK medical device manufacturers?

Obviously, the key date to consider is the 31st October 2019, after this date UK based device manufacturers may no-longer be permitted to legally place product on the EU market without appointing an EU Authorised Representative (EC Rep).

If a deal is struck between the EU and the UK the implementation period that has already been agreed allows UK manufacturers until December 2020 to appoint an EC Rep and update your information and materials, including, but not limited to, packaging, product labels, IFU’s, brochures, CE Certificate, and Declarations of Conformity where you can be expected to indicate the name and address of your EC Rep.

However, if the UK crashes out of the EU without a deal on the 31st October 2019 (and this is now the most likely outcome) the implementation period is removed, the EU will not provide a transition period, meaning that UK device manufacturers will almost certainly be locked out of the EU until such time that they have appointed an EC Rep, updated device registrations and their information and materials as mentioned above.

Equally all manufacturers based outside the UK wishing to continue to market within the UK after a no-deal Brexit, must be aware of the new requirement for a dedicated UK Responsible Person (UK RP). The UK RP would be responsible for performing registrations with the MHRA. We provided some guidance back in February and again in March which suggested that Advena Ltd UK will be able to offer this service.

Therefore, October 31st, 2019 will be a critical date!

We strongly recommend both UK based, and non-UK based medical device manufacturers contact Advena to discuss the options available to them. We are uniquely based in the UK and in Malta, where we offer our EU Authorised Representative service from Malta, the UK Responsible Person service from the UK and a full range of medical device regulatory and QMS consultancy services from both offices, therefore a local UK/EU service to help maintain both EU and UK market access. And of course, we are English speaking as is our team in Malta.

With over 20 years’ experience as a provider of regulatory services we have a wealth of knowledge that you can benefit from.

Please contact our team for more details: info@advenamedical.com

Meet Advena in Miami at FIME 2019

Advena are exhibiting at FIME 2019, this trade fair is considered one of the most important across the Americas and is taking place at the Miami Beach Convention Center in Florida.

Advena will be located at booth B45 in the gold zone, at this important show in Miami from 26th to 28th June 2019.

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

Attending on behalf of Advena Ltd., is the Managing Director from our Maltese office, Anthony Kirby. It would be fantastic to connect with any of our clients who plan to visit this important Americas trade show, so please do stop by our booth or contact us for an appointment;

Email: info@advenamedical.com

Further details about FIME 2019 may be found at this link

ISO 13485:2016 Success For Advena Ltd in Malta!

Advena Limited,  Malta have chalked up a remarkable success!

Following the successful re-certification audit at our UK office at the end of February 2019, the next task was to audit our office in Malta (an EU27 member state) for inclusion on our ISO 13485:2016 certification. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our Maltese team, the result of which, after a gruelling audit by LRQA, one of the UK’s most respected Notified Bodies, was a glowing report and more importantly achieving the much converted certification it needed to move its EU Authorised Representative (EC REP) business forward.

If you’re looking for an EC REP based in the EU27 or are looking for QMS consultancy to ISO 13485:2016 please contact us for more details and become part of a success story.

Email Advena: info@advenamedical.com

 

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