At the end of November 2018 we already covered the possibilities of the EU Commission to initiate minor changes to the MDR and included where you can find information on delegated acts. (Delegated Acts/Nov.2018). As promised Part 2 is now published: major changes to the MDR according to implementing acts. In a sense the big brothers of the delegated acts. We were wondering: What is the current scheme of things? Which articles of the MDR are affected and how does the EU Commission actually issue implementing acts?
The current situation: Soon two of the three years of the transition period of the new MDR will be over and yet it is not clear which changes exactly will be carried out. Up to know only one implementing act was issued under the MDR, even though a wealth of them would be required for smooth implementation. The current status of the drafts can be tracked via the Comitology Register for implementing acts and the drafts may be accessible upon request. Up to now the following drafts were drawn up:
- 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 23rd November 2017 upon resubmission of the draft as „Implementing Act (EU) 2017/2185 of the Commission” and covers the list of codes for specifying the designations of a notified body.
Adoption of Implementing Acts in line with the Advisory or Examination Procedure
According to Article 114 the adoption of Implementing Acts under the MDR underlies either the Advisory Procedure or the Examination Procedure. In case of urgency an immediately applicable act can be implemented, however, it can be repealed again upon a downstream performed Advisory or Examination Procedure.
During the Advisory Procedure the committee consults on the implementing act to be adopted. If required, a vote is taken. During the Examination Procedure, that is mainly applied in case of the MDR, representatives from the member states vote on adopting the proposed Implementing act within a committee. The Commission has to consider the opinion delivered subsequently. It is entirely possible that no opinion is delivered. In that case the commission can adopt the act, provided it does not affect any risk-associated topics (e.g. taxation, the protection of the health or safety of humans, etc.) and the basic act excludes adoption where no opinion is delivered.
However, the MDR excludes this possibility expressly, so an adoption without opinion is not possible, only anew submission of the draft is possible. Further stipulations regarding control of implementing acts are given in REGULATION (EU) Nr. 182/2011.
Implementing Acts following the Advisory Procedure
As a matter of fact there is only one article subjected to the simpler Advisory Procedure, and that is:
- Article 32.3: Stipulations regarding the form and the presentation of the data elements to be included in the summary of safety and clinical performance
Implementing Acts following the Examination Procedure
All other implementing acts provided for within the MDR are subject to the Examination Procedure:
- Article 4: Determination of the status of a medical device or accessory by the Commission upon request of a member state
- Article 5 (6): Uniform application of Annex I, MDR
- Article 9 (1): the adoption of 'common specifications' to replace or supplement harmonised standards specifying the requirements of Annex I, the technical documentation listed in Annexes II and III, the clinical evaluation and post-marketing clinical follow-up listed in Annex XIV or the clinical trial requirements listed in Annex XV
- Article 27: Designation of entities to issue UDI and detailed regulations on the identification system
- Article 33 (8): Establishment and maintenance of Eudamed
- Article 36: Requirements for notified bodies, additions to the uniform interpretation and implementation of Annex VI
- Article 39(10): Application and assessment for approval as Notified Body
- Article 42(13): Definition of codes for medical devices types to be assigned to the responsibilities of Notified Bodies
- Article 45 (6): Performance and documentation of technical documentation and clinical evaluation reviews by Notified Bodies
- Article 47(3): Restriction, suspension or withdrawal of the authorisation of a Notified Body in case a Member State fails to fulfil its surveillance obligations towards the Notified Body
- Article 48 (5): Peer review mechanism and the training and qualification of authorities responsible for Notified Bodies
- Article 51(3, 4 und 5): After consulting the Medical Devices Coordination Group: Classification according to Annex VIII, modification of the classification of products or product groups, modification of the rules.
- Article 52(14) Details on the implementation of the conformity assessment procedure: frequency and basis of sampling for the assessment of technical documentation on a representative basis, minimum frequency of unannounced audits, physical and laboratory tests
- Article 59(3): Extension, for a limited period of time, of a product exemption granted by a single Member State
- Article 60: Establish a model for certificates of free sale
- Article 61(13): Rules for the uniform application of Annex XIV
- Article 70(9): Rules for the uniform interpretation and practical application of Annex XV, Chapter II (Clinical Trial Request)
- Article 78(7): Regulation of procedures and deadlines for coordinated evaluations of clinical trials (multinational studies with sponsor's request for the coordinated procedure)
- Article 81: Uniform electronic forms for applications for authorisation of clinical trials and their evaluation, functioning of the electronic system for recording and evaluating clinical trials, uniform electronic forms for the reporting of post-marketing clinical trials, exchange of information between Member States, uniform electronic forms for the reporting of serious adverse events and product defects, time limits for the reporting of serious adverse events and product defects taking into account seriousness, uniform application of clinical proof 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: Procedure for the evaluation of national measures at Union level: decision-making procedures in the case of different evaluation of measures between the authorities of the Member States
- Article 97: Unification of certain non-compliance measures
- Article 98(3): Preventive health protection measures in consultation with the Medical Devices Coordination Group
- Article 106 (1): Designation of expert panels for the clinical evaluation and performance evaluation of IVD or (7) designation of specialised laboratories, (13) fees for these activities.
- Article 112: Eligible fees for the joint assessment of Notified Bodies
As you can see, the EU is not making it easy for itself with its change management system either. Drafts, agreements and ultimately the approval by the participating countries and/or EU institutions are also necessary here. And there is still a lot of work to be done by the EU to ensure smooth implementation.
If you are in need for support with the introduction of 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 continue to comply with all known and future MDR requirements.
Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.