At the end of 2022, a new decision in the world of medical devices sought to address some significant challenges that the implementation of the new Regulation brought. There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Consequently, the validity of CE Certificates is to be prolonged. Following this agreement, the EU Commission published an official proposal in January 2023.
New transitional period for legacy devices
To avoid a shortage of medical devices in the Union market and allow a smoother transition towards MDR, the European Commission aims to introduce new major measures. First of all, the Proposal foresees an extension of the transitional period. The new deadlines to be fully MDR compliant are 2027 and 2028, depending on the class of the device. Based on the new deadlines, the CE Certificate issued under the Directives will have a longer validity period. Secondly, there would no longer be the “sell off” provision. The “sell off” provision imposes that devices compliant with the Directives and lawfully placed on the EU market before the Regulation should be removed from the market within a specific date. The removal of the “sell off” provision applies to in vitro diagnostic medical devices as well.
Requirements for manufacturers according to the new Proposal
According to the Proposal from January 2023, manufacturers of legacy devices can benefit from the extended legacy periods and prolonged certificates validity if they meet following requirements:
- They have not performed any significant changes to their device after the MDR date of application.
- Their device does not present any unacceptable risk to health and safety.
- They respect legacy requirements set out by MDR.
- They are undertaking necessary steps to reach MDR compliance. In particular, manufacturers must set-up an MDR complaint QMS by May 2024, and approach a notified body by May 2024 and sign a written agreement by September 2024 for a new MDR certification process.
However, if the Certificate is expired before the new Proposal enters into force (expected at the beginning of 2023), manufacturers will be able to benefit from the extended transitional periods and prolonged certificates validity only in case one of the following conditions is fulfilled:
- Before the certificate’s expiry date, the manufacturer has signed a written agreement with a Notified Body for the MDR Certification of the device covered by the expired certificate or in respect of a device intended to substitute that device.
- An EU competent Authority has granted a derogation pursuant Article 59 or Article 97 MDR.
MDCG Position Paper on derogation process for expired certificates
In December 2022, the Medical Device Coordination Group (MDCG) published a position paper on the application of MDR Article 97 (MDCG 2022-18). Under Article 97, manufacturers can be granted an authorisation to continue placing legacy devices after the Directive’s certificate expires before the issuance of the MDR certificate.
Once the CE certificate expires, the Authorised Representative of a non-EU manufacturer must inform the Competent Authority about this non-compliance. To be granted a derogation, the Authorised Representative should submit an application to the Competent Authority on behalf of the manufacturer. The application should include a report with data from the post-market surveillance system (PMS), containing data on incidents, serious incidents, and field safety corrective actions. Afterwards, a written communication will follow granting the derogation if the Authority considers that the device does not present an unacceptable risk to health and safety.
Especially, manufacturers can be granted this derogation under Article 97 only when they have already undertaken reasonable efforts to solve this non-compliance (expired certificate):
- A notified body must already have accepted the manufacturer’s application for a new certificate.
- There must already be a written agreement signed by notified body and manufacturer.
How are SMEs impacted by the MDCG position paper?
If the manufacturer is a SME, the requirement to have a signed agreement with a Notified Body can be waived under following conditions:
- The manufacturer has a certificate issued by a notified body not (yet) designated under the MDR.
- The manufacturer can prove that they have already applied to various notified bodies, but their application was rejected due to the limited capacities of the notified bodies.
After assessing that the SME meets the requirements mentioned above, the Competent Authority will give the manufacturer a deadline to solve the non-compliance and find a Notified Body (typically 12 months).
Manufacturers need to act now
During late 2023 and 2024, many certificates issued under the Directives on medical devices and active implantable medical devices will expire. To consider these certificates valid – as per the new Proposal – manufacturer must approach a Notified Body within May 2024. To be able to still place the devices on the EU market, manufacturers need to act now to find a Notified Body, as the capacity of Notified Bodies is limited, and the number of applications they receive is constantly rising.
Do you need help to find a Notified Body as soon as possible? Contact us today!
Simona Varrella
Publications Department
18/01/2023
References:
EPSCO. (2022). Employment, Social Policy, Health and Consumer Affairs Council (Health), 9 December 2022. Retrieved on 09.12.2022.
European Commission. (2022). Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Retrieved on 18.01.2023.
MDCG. (2022). MDCG Position Paper – Application of Art.97 MDR to legacy devices for which an MDD/AIMDD certificate expires before the issuance of a MDR certificate. Retrieved on 30/12/2022.
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