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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.

Quality Management Systems (QMS) Under the MDR

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. Article 10 (9) of the MDR goes into further detail.

Manufacturers should be looking closely at their QMS to ensure it meets the requirements of the Regulation. A QMS to ISO 13485:2016 will cover most of these aspects, but not all. Therefore, it will be vitally important to carry out a review of your QMS.

The implementation of the MDR to 26th May 2021 is not far away, so please use this time wisely.

If you don’t have the resources internally or locally, remember Advena have a team of consultants who can help and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.

Email us at: Info@advenamedical.com

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

 

ISO 13485: 2016 MDSAP – Gap Analysis

ISO13485:2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard.

Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version and become certified.

In addition if it’s your intension is to access USA, Brazilian, Japanese, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).

At Advena we have experts who specialise in guiding manufacturers to compliance whether it’s ISO13485:2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.

The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.

After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.

This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow a gap analysis to be conducted internally.

For more information on how Advena can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS please contact us at info@advenamedical.com for a detailed quotation.

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