A week ago, we blogged about how to deal with non-compliance due to the gap between the expiry of MDD/AIMDD certificates and the issuance of MDR certificates by applying Article 97 MDR. However, this approach only does not seem to solve the problem of potential supply disruption in the EU due to the number of certificates expiring in 2023 and 2024. Now European Commission is proposing another amendment to the EU MDR and IVDR. It is understandable that this new piece of regulation change adds extra works to all stakeholders in medical device industry, however, it will certainly relieve everyone of the already tightened stress. Be prepared to study this proposal in advance, because you can only benefit from this amendment when certain conditions are met.
Changes made to EU MDR
Changes made to EU IVDR
1. extend the transitional period
a) MDD/AIMDD certificates issued from 25.05.2017 and valid on 26.05.2021 remain valid until 2027/2028 (see below) after certificates are expired.
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- 31.12.2027: for class III and IIb implantable, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
- 31.12.2028: for class IIb, IIa and Is/Im
b) self-declared devices under MDD/AIMDD, the issue date of declaration of conformity were before 26.05.2021 and requiring a certificate according to MDR may be placed on the market or put into service until 31.12.2028.
c) class III custom-made implantable devices may be placed on the market or put into service until 26.05.2026 without a certificate from a notified body.
2. delete the “sell-off” deadline
1. delete “sell-off” deadline
a) “sell-off” deadline is the end date for the further making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the extended transition period is over.
b) the current “sell-off” date in the EU MDR and IVDR is 27.05.2025 and 25.05.2025 to 26.05.2028 respectively. With the removal of “sell-off” deadline further making available of devices (IVDs and MDs) are unlimited in time.
Based on the summary above it is clear that the extension of transitional period is proposed only to amend the EU MDR because the staggered transition of IVDs based on the IVD risk was already included in the EU IVDR early last year. The medical devices that are to benefit from this extended transition period must meet several cumulative conditions:
(a) Directive 90/385/EEC or Directive 93/42/EEC compliant;
(b) no significant changes in the design and intended purpose;
(c) do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
(d) no later than 26 May 2024, the manufacturer has put in place a quality management system;
(e) no later than 26 May 2024, a formal application for conformity assessment according to EU MDR has been filed and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement.
It should be noted that this amendment is being proposed with urgency by the European Commission and that some operational guidance is await from the MDCG group in the coming months explaining how importers and distributors should comply with their verification obligations, especially in relation to the expired certificates, but the devices can still be placed on the market.
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