While this means that the outlook for MDR implementation is more positive, the Commission’s approach is disappointingly piecemeal in nature. There are still some key open issues on certificate extensions, and the proposal does not address the In Vitro Diagnostic Regulation (IVDR) in any detail. Manufacturers now need to wait for these developments to materialise into a (hopefully more holistic) legislative amendment.
Manufacturers are navigating challenging regulatory headwinds: the ultimate deadline for recertifying medical devices is 26 May 2024. However, a sizable number of certificates issued under the previous regime in the Medical Device Directive and the Active Implantable Medical Device Directive (Directives) are expiring sooner than this. This means that many devices must comply with the MDR even sooner than 26 May 2024, all while notified bodies struggle with capacity. These factors are combining to create a perfect storm.
Please reach out to us if you would like to discuss this, including Article 97 applications.
Top five takeaways on recent developments:
- Extending transitional periods: The Commission has proposed an extension of the transitional periods (in Article 120(3) of MDR) for the placing on the market of devices regulated under the MDR:
|Device class under MDR
||Proposed transition period
|Class lx (up-classed)
- Proposed certificate extensions if needed “for legal and practical reasons”: The Commission proposes that if needed for “legal and practical reasons”, the extension of the transitional periods could be combined with an extension of the validity of certificates issued under the Directives (Article 120(2) of MDR). It’s not clear what constitutes a sufficient “legal and practical reason”, but the Commission gives the example of access to third country markets. This may suggest that regulators will grant or extend free sales certificates (Article 60, MDR).
This is a key open issue – manufacturers need an extension of certificates if they are to avoid a situation where they need to apply for Article 59 derogations when their certificates expire (and, if derogations are not obtained, the devices must cease to be placed on the internal market). A further oversight is that the Commission’s proposal does not address certificate extensions under the IVDR, despite acknowledging the low number of designated notified bodies for IVDs.
- Conditions for certificate extensions need clarification: Certificate extensions will only be available for a device if:
- The device does not present unacceptable risk to health and safety. We expect that manufacturers may reasonably rely on vigilance and PMS data to demonstrate the absence of these risks.
- The device has not undergone significant changes in design or intended purpose.
- The manufacturer has already taken necessary steps to launch the certification process under the MDR, such as adaptation of their QMS to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before the deadline (e.g., 26 May 2024). These criteria merit clarification from legislators - the examples have unclear implications. There is a wide gulf in “MDR readiness” between:
- Acceptance of the application of the manufacturer by the notified body for conformity assessment. Although this is an objective criterion that can easily be verified, this will do little to resolve delays as notified bodies continue to face capacity issues. It's not clear whether a notified body’s reply to a mere pre-application (reflecting processes implemented by some notified bodies) suffices to qualify for the extension.
- A manufacturer adapting a QMS, which is practically more difficult to verify. Manufacturers might resort to self-audits or QMS audit reports from independent regulatory consultants.
- Removal of the “sell-off” provision: The Commission proposes removing the provision setting out that devices that are on the market can continue to be sold until May 2025 (Article 120(4) MDR and Article 110(4) IVDR). This means devices will not need to be recalled or discarded by this date.
- The interim solution - Article 97 and the impact of the MDCG Position Paper (2022-18): While the Commission has not yet confirmed an extension of certificates, a supplemental or short-term solution is this Position Paper. This allows manufacturers to benefit from an exemption under Article 97 for a temporary period, but is only a “quick fix”. Whilst we welcome that Article 97 has been acknowledged as a procedure allowing for proactive applications submitted by manufacturers (replacing the Article 59 derogation route), it is doubtful that competent authorities will have the capacity to actually assess and consistently apply Article 97 in a reasonable time frame:
- Which devices does this route apply to? The Position Paper applies Article 97 to manufacturers whose certificates of conformity have expired, or which will expire before they are issued by a notified body under the MDR. In other words, it only applies to devices that are ‘in transition’ from the Directives to the MDR or where, despite reasonable ef-forts undertaken by the manufacturer, the conformity assessment procedure has not been concluded in time.
- How to make an Article 97 application: These manufacturers can make an application under Article 97 of the MDR to a competent authority in the Member State in which either the manufacturer or its Authorised Representative have their registered place of business.
- Evaluation by competent authority: The competent authority must then perform an evaluation under Article 94 to ensure the device does not present “an unacceptable risk” and there are no other non-conformities (other than certificate expiry). For the purposes of this evaluation, the manufacturer must submit a report containing relevant data gathered through its PMS system (data concerning incidents, serious incidents and/or field safety corrective actions)
- Pre-conditions for application: In order to rely on this process, the manufacturer should already have undertaken “reasonable efforts” to transition its device to the MDR. That means ensuring the manufacturer’s application for conformity assessment under the MDR has already been accepted by a notified body under an already executed MDR agreement. However, this requirement may be waived for certain SMEs.
- If the application is successful: If the competent authority determines that the device doesn’t present an unacceptable risk, the competent authority will issue a so-called “written communication” specifying a “reasonable period” to remedy non-compliance. According to the Position Paper, this will generally not be more than 12 months. It seems likely that many manufacturers will need to make repeat applications on an annual basis, given this short period. The Position Paper encourages authorities to issue or extend free sales certificates which manufacturers/EARs might want to flag in their applications.
- Next steps after exemption granted: The MDCG reminds manufacturers benefiting from a granted Article 97 exemption to comply with Article 10(12). This requires a notification of non-compliance to (third party) distributors and, if applicable, importers, while also informing about the Article 97 exemption. Manufacturers should follow this advice, to pre-empt potential complaints about alleged legal defects based on technical loss of CE marking for devices.
The members of the Council of the European Union support the proposal to extend transitional periods. This means an amendment is needed to the MDR, which will need to be approved by the Council and the European Parliament. Given the Commission’s proposal did not address the IVDR or certificate extensions in definitive terms, industry will be hoping that legislators remedy this in the next stages, rather than relying on Article 97 and the MDCG’s Position Paper (which doesn’t represent a long-term solution to re-certification issues).
In the meantime, manufacturers may consider preparing or expediting Article 97 applications for temporary MDR exemption.