At the end of November 2018, we already reported on the extent to which the EU Commission may initiate minor changes to the MDR and where you can find out about delegated acts (Delegated acts/Nov. 2018). As promised, here comes part 2: substantive changes to the MDR according to the implementing acts. In other words, the big brothers of the delegated acts. We ask ourselves: what are the current circumstances? Which articles in the MDR are affected, and how can the EU Commission actually adopt planned implementing acts?
The current state of affairs: soon, two out of three years of the transition period of the new MDR will have passed, and it is still not clear what exact changes will be made. So far, there are no finalized implementing regulations for the MDR, although a large number would be necessary for smooth implementation. The current status of drafts can be tracked through the Comitology Register of Implementing Acts, and drafts may be viewed upon request. The following drafts have been produced to date:
Preliminary draft of a future Commission Implementing Regulation on Common Specifications for the reprocessing of single-use medical devices.
Preliminary draft of a future Commission Implementing Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices and in vitro diagnostic medical devices
COMMISSION IMPLEMENTING REGULATION on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
Draft number 3 was adopted on November 23, 2017 after resubmission under “Commission Implementing Regulation (EU) 2017/2185” and concerns the code list for determining the scope of designations of a notified body.
Adoption of implementing acts in accordance with the examination and advisory procedure
The adoption of implementing acts is subject to either an advisory procedure or a review procedure in the MDR under Article 114. In cases of extreme urgency, they may also be adopted immediately, but this may in turn be overturned in a downstream review or advisory procedure.
In the advisory procedure, the committee deliberates on an implementing act to be adopted. If necessary, a vote is taken. In the review procedure, which is primarily applied in the context of the MDR, the representatives of the member states vote in a committee on the adoption of the proposed implementing act. The Commission must then take the communicated opinion into account. It may well be that no opinion is given. In this case, the Commission may adopt the act, provided that the act does not concern risk issues, (e.g., taxation, protection of health or safety, etc.) and the basic act does not preclude amendment without an opinion.
The MDR, however, excludes this possibility, so there can be no enactment, only a resubmission of the draft. Further rules on the control of implementing acts are described in REGULATION (EU) No 182/2011.
Implementing acts under the advisory procedure
In fact, there is only one article subject to the simple advisory procedure, namely:
Article 32(h): specifying the type and presentation of the data elements that the summary report on safety and clinical performance must have.
Implementing acts following the review procedure.
All other implementing acts provided for in the MDR are subject to the review procedure:
Article 4: Determination of medical device or accessory status by the Commission at the request of a member state.
Article 5 (6): binding interpretations on Annex I, MDR
Article 9 (1): adoption of “common specifications” to replace or supplement harmonized standards to specify the requirements of Annex I, the technical documentation listed in Annexes II and III, the clinical evaluation and post-market clinical follow-up listed in Annex XIV, or the clinical investigation requirements listed in Annex XV
Article 27: Designation of bodies to issue UDI and detailed rules on the award system.
Article 33 (8): Establishment and maintenance of Eudamed
Article 36: Requirements for Notified Bodies, additions for uniform interpretation and implementation of Annex VII
Article 39 (10): Application and evaluation for approval as Notified Body
Article 42 (13): Establishment of codes on types of medical devices so that they can be assigned to the responsibilities of the Notified Bodies.
Article 45 (6): performance and documentation of the review of the technical documentation and the clinical evaluation by the Notified Bodies
Article 47(3): restriction, suspension or withdrawal of the authorization of a Notified Body if a member country does not fulfill its surveillance obligations to the Notified Body
Article 48(5): mechanism of peer review and training and qualification of authorities responsible for Notified Bodies
Article 5 1(3, 4 and 5): After consultation of the Medical Devices Coordination Group: Classification according to Annex VIII, change of classification of devices or groups of devices, change of rules.
Article 52 (14) Details on the implementation of the conformity assessment procedure: Frequency and basis of sampling in the evaluation of technical documentation on a representative basis, minimum frequency of unannounced audits, physical and laboratory examinations
Article 59 (3): extension for a limited time, of an exemption granted by a single member state for a product
Article 60: Establishment of a template for certificates of free sale
Article 61 (13): Rules for the uniform application of Annex XIV
Article 70(9): rules on the uniform interpretation and practical application of Annex XV, Chapter II (clinical investigation application)
Article 78(7): regulations on procedures and deadlines for coordinated assessments of clinical trials (multinational studies with sponsor’s request for the coordinated procedure)
Article 81: Uniform electronic forms for clinical trial authorization applications and their evaluation, operation of the electronic clinical trial registration and evaluation system, uniform electronic forms for post-marketing clinical trial notification, exchange of information between member states, uniform electronic forms for reporting serious adverse events and device defects, deadlines for reporting serious adverse events and device defects taking into account the severity, uniform application of the clinical evidence requirements or data necessary to demonstrate compliance with the essential safety and performance requirements set out in Annex I.
Article 91: PMS and vigilance, detailed arrangements and procedural elements.
Article 96: procedures for the evaluation of national measures at Union level: decision-making procedures in the event of differences in the evaluation of measures between Member State authorities
Article 97: standardization of certain measures in case of non-compliance.
Article 98 (3): preventive health protection measures after consultation with the Medical Devices Coordination Group
Article 106 (1): designation of expert panels for the peer review of clinical evaluation and performance assessment of IVDs, respectively (7): designation of expert laboratories, (13) fees for these activities
Article 112: Reimbursable fees for joint assessment of notified bodies.
As you can see, the EU does not take the easy way out with its amendment system. Drafts, agreements and ultimately approval by the countries and/or EU institutions involved are also necessary here. And there is still a lot of work ahead of the EU to ensure a smooth implementation.
If you still need support in implementing the MDR requirements or a change management system tailored to your needs, you are welcome to contact us in confidence. We will ensure that you remain compliant with all known and upcoming MDR requirements.
Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.
