In the European Union, medical devices are regulated by the EU Medical Device Regulation 2017/745 (MDR), which replaced the previous Medical Device and Active Medical Device Directives, and began to apply on 26 May 2021. This means that from that date, all new medical devices being placed on the EU market will need to conform to the MDR.
EU 2017/745 has introduced many new requirements which need to be met by all stakeholders of the medical device industry. As a result, all manufacturers have been required to put into action a transition plan to ensure their devices have a spot in the EU market. Article 120(3) is arguably one of the most crucial sections of the entire Regulation:
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.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.Article 120(3), EU MDR
What about devices previously marketed in the EU? #
In order to avoid a major disruption in the industry, the MDR contains Transitional Provisions in Article 120 intended to provide a period of grace for devices which are compliant with the EU Medical Device Directive 93/42/EEC (MDD) or the EU Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
Article 120 allows manufacturers of medical devices under the previous Directives with a valid CE Certificate to continue to place their Directive-compliant devices on the market until the end of the validity period indicated on the certificate. In order to maintain their place on the market, manufacturers will need to submit their devices for conformity assessment against the EU MDR requirements prior to the expiration of their Directive certificate.
Originally, products covered by a valid certificate were the only devices planned to be allowed to continue being placed on the market following the Date of Application of the MDR. However, the Second Corrigendum to the Regulation introduced additional provisions to extend the grace to devices which now require Notified Body intervention under the Regulation.
Therefore, self-declared Class I devices under the MDD which will require the intervention of a Notified Body for conformity assessment under the EU MDR will benefit from an additional 3-year grace period and must comply with the MDR by 26 May 2024. However, it is vital that such devices are covered by a Declaration of Conformity issued against the EU MDD and drawn up prior to 26 May 2021. See our article on the Second Corrigendum, here.
In both of the above cases, Directive-compliant medical devices benefiting from Article 120 to continue being placed on the market are commonly referred to as “legacy devices“.
On the other hand, Class I devices placed on the market under the MDD which are Class I under the MDR and which do not require additional Notified Body assessment, are not so lucky. Such devices needed to transition to the MDR by 26 May 2021 to continue being placed on the market legally.
We recommend that any manufacturer of legacy devices benefiting from Article 120 put together a robust rationale taking into account the intended purpose as well as the eligibility criteria of the device. It will come in handy if challenged by a Competent Authority.
Terms & Conditions #
As with many good things in life, terms and conditions do apply. In the case of Article 120, two main conditions must be met to continue benefiting from the grace period.
Applicable MDR Requirements #
Article 120(3) indicates that legacy devices are still required to comply with a few requirements of the EU MDR 2017/745. These are:
- Post-Market Surveillance.
- Market Surveillance.
- Registration of Economic Operators and Devices.
This means that as of 26 May 2021, legacy devices on the market need to make sure that their technical documentation and procedures for the above sections are compliant with the MDR. Surveillance audits for those legacy products under Notified Body assessment will have needed to have the necessary documentation in place, or risk a nonconformity being raised. Furthermore, it would certainly be a good idea to have a transition plan in place and recorded as part of your quality system; this should give sufficient detail on how your organisation plans to meet the Regulation’s requirements.
The EU’s Medical Device Coordination Group (MDCG) released an excellent guidance document in the form of MDCG 2021-25 which discusses which requirements in the MDR are applicable to legacy devices.
No Significant Changes #
Article 120(3) is quite specific in saying that there must be no “significant changes in the design and intended purpose” of the medical device in order to continue being placed on the EU market in compliance with the Directives. But what does significant mean?
MDCG to the rescue again! Guidance document MDCG 2020-3 is yet another influential document which provides some recommended context and assistance in understanding the significance of changes made to the device. Manufacturers may even follow some helpful flowcharts to help them determine whether any device alterations are considered to be significant or not.
As a general rule of thumb, any change made to the device which leads to an alteration of its intended purpose such that the manufacturer must collect additional data to demonstrate its safety and performance (such as the addition of a clinical indication) will be considered significant. Furthermore, a new feature added to the device will also be considered significant. However, changes to the device’s name or colour should not be considered significant unless it does actually influence the intended purpose of the product. In any event, it is crucial that any changes to the device are documented, and any rationale for “non-significance” recorded.
How We Can Help #
Specculo can assist you with your transition plan to the EU MDR and can put together your Article 120 eligibility rationale based on your intended purpose. We have a wide range of services which you may find helpful, and we encourage you to get in touch with us or visit our service pages to understand how we can help you better.