The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 are directly applicable and are directly addressed to stakeholders involved in making devices available on the EU market supporting the provision of health-related services to EU patients and consumers. National legislation implementing and transposing regulatory requirements set out in the previous EC Directives on medical devices has had to be – or is being – modified to implement the necessary repeals and to provide references to the new regime. Using a regulation to harmonise the rules at Union level provides for a more level playing field. Nevertheless, national requirements additional to the regulations still exist, in many cases to empower the National Competent Authorities to implement market surveillance but also to enable them to develop further legislative provisions at a national level – for example, concerning issues where no consensus was reached when establishing the MDR and IVDR. This presentation explores some of those issues placing focus on the specific case in Spain where, having overcome a complex legislative process (including EU oversight), a new Royal Decree on medical devices is now imminent.
Such issues include:
– License requirements for manufacturers and importers established in Spain;
– The Responsible technician to directly supervise manufacturing, importing and distribution activities;
– Registration of distributors and devices being made available on the Spanish market;
– Spanish language requirements for information supplied with devices;
– The authorisation process for clinical investigations to be conducted in Spain;
– Requirements for in-house manufacturing in Spanish healthcare institutions as well as requirements for reprocessing single-use devices to be used in these institutions;
– Requirements applicable to advertising and promoting medical devices (further developed in other specific legislation), and
– Definitions of infringements of the applicable requirements and the related penalties.
MDR (EU)2017/745 was supposed to fully enter into force in May 2024 creating huge pressure on manufacturers and Notified Bodies to upgrade their system to new requirements. Objective of this presentation in to share the status of NB in terms of workload and planning. It will provide also some feedback on commonly observed issues from application level to certification.
The Medical Device Regulation (EU MDR) was published in 2017 with a transition period of 3(4) years. This transition period was planned to ensure a smooth transition from the old Directives to the EU MDR. Nevertheless, after more than 5 years of its publication less than 40 notified bodies were designated for the EU MDR leading to a huge capacity limitation during the implementation time. Those successful bodies were just able to issue less than 2000 certificates in approximately 3 years period leading to 17000 certificates on a transitioning waiting list. The certification process is taking up to 18 months due to the higher scrutiny and complexity of the EU MDR. So, the big question remains open: Will the EU healthcare system start suffering from May 2024? This presentation is intended to give a realistic update and share an impact assessment of the “new changes” to the EU Legislation.
The EU Artificial Intelligence (AI) Act is a proposed horizontal legislation that will introduce regulatory requirements for any high-risk product based on machine learning and other artificial intelligence technology, including medical devices and specific health tech.
The Regulation establishes requirements and obligations for providers of high-risk AI systems, including establishing risk and quality management systems, technical documentation, and record-keeping. There are also transparency, human oversight, accuracy, and robustness obligations. E.g. where AI systems use datasets, these will need to be of high quality to minimize risks and avoid discriminatory outcomes.
Notified bodies need to combine the conformity assessment under the medical device regulations with that under the AI Act. Harmonized standards will become available to provide a presumption of conformity; some will likely overlap with existing harmonized standards in support of the Medical Device Regulations.
In this session, Koen Cobbaert will introduce the proposed AI Act, sketch the interplay with the Medical Device Regulations, and discuss the implications for authorized representatives.
A brief overview of regulatory requirements for medical device software according to MDR 2017/745, and IVDR 2017/746. Challenges when qualifying and classifying medical device software and apps, for example rule 11 in the Medical Device Regulation. Strategies on how to successfully fulfil the requirements in the MDR and IVDR, having in mind new challenges and technologies, for example Cybersecurity and Artificial Intelligence.
EUDAMED is the European database on medical devices and is one of the key aspects in the implementation of the EU MDR & IVDR objectives.
It will become a mandatory requirement to register certain actors and any medical device in the database with important implications for manufacturers and authorised representative.
By following this session, you will get an insight on the most recent EUDAMED status and timeline, as well how to comply with the registration requirements in the first two modules of EUDAMED (actor & device registration) and what is the role of the Authorised Representative.
The Person Responsible for Regulatory Compliance (PRRC) is mentioned in Article 15 MDR/IVDR. The role of the PRRC is new and at this moment there is limited guidance and there are no standards. With the manufacturer responsible for ‘everything’ concerning the device, the question is what would be the role of the PRRC. One of the results of the TEAM PRRC Summit in November 2022 was that the PRRC may be held internally responsible, but they are not externally liable. According to the MDCG, the PRRC was introduced to be a source of expertise within an organization. The PRRC should observe, guide and comment. But the PRRC should not act.
Of course, these are very interesting and noble principles, but what do they mean in practice? Especially in the case of small organizations that have to do with limited staff numbers. And the PRRC can be in an isolated position, where it is difficult for them to exchange views with others.
In this presentation, the latest views on how to implement this role compliantly and some suggestions will be made about how a manufacturer can make optimal use of the PRRC.
Few aspects of the Regulations raised as many questions as the introduction of the Person Responsible for Regulatory Compliance (PRRC). Paragons for this role can already be found in national transpositions of the former regulatory framework e.g. with the Safety Officer in Germany focussing on the post-market phase of a device including surveillance and vigilance activities. The MDR and IVDR significantly enhance the responsibilities by adding the pre-market phase of a device life cycle. They further define the PRRC qualification requirements and adjust the application of Article 15 to smaller companies, both of which are elaborately explained in supporting guidance documentation. In contrast, the rather critical aspect of defining the consequences of the “responsibility” and with that the significance of the PRRC within a company yet has to be learnt/defined by the industry and judiciary decisions.
Additionally for authorised representatives and with that for the EAAR, one aspect is of crucial importance: The responsibilities of the PRRC are reminiscent of the tasks mandated to an authorised representative. It thus seems surprising that while Article 15.6 stipulates the PRRC for an EC REP, the Regulations remain silent regarding the responsibilities of an EC REP’s PRRC and raise the concern about a dictated redundancy. This gap can partly be filled by supporting guidance, however some aspects remain object to discussion and likely with time will find their interpretations.
An overview with background and status regarding the harmonisation process of standards in support of MDR 2017/745 and IVDR 2017/746.
What has been done so far and what lies ahead? What to do in case of absence of harmonised standards? What does state of the art mean?
The presentation includes an elaboration on the purpose and benefit of harmonised standards in the European context. Status and ongoing work program in MDCG Subgroup Standards will be discussed.
Senior Regulatory Affairs Specialist, Medicines and Healthcare Products Regulatory Agency (MHRA), UK
The presentation will focus on the Government response to the consultation on the future regulation of medical devices in the United Kingdom and the current status of implementation.
It will focus in on the elements applicable to UK Responsible Persons as well as covering some of the more general topics that may be of interest to the audience.
The UK Responsible Person Association(UKRPA) is open to all companies and persons acting as UK Responsible Persons (UKRP). It aims to foster high level competence and professionalism among UKRPs. It works in partnership with the UK Competent Authority MHRA and other trade associations based in the United Kingdom.
The withdrawal of UK from the European Union (Brexit) has created a challenging regulatory environment for medical device manufacturers. Non-British manufacturers must be represented in Britain by a UK Responsible Person. UK did not adopt the new EU regulations (MDR and IVDR) but plans to introduce new requirements that may be very similar to the MDR and IVDR. Manufacturers wishing to obtain the UKCA marking must comply with requirements that are based on the old EU Directives.
The UK left the EU in Jan 2021- the UK continues to accept CE marking to place devices onto the market as well as UKCA marking, whilst UKCA marking was supposed to be mandatory from July 2023 this deadline has now been extended by a further 12 months until new legislation can be drafted. It’s been over 2 years now and BSI has issued numerous certificates under the UK MDR 2002 for UKCA marking. This session will cover how devices are placed on the market currently in the UK, what the conformity assessment looks like with an Approved Body, lessons learnt from applications BSI has received to date and what the future may hold.
Senior Regulatory Affairs Specialist, Medicines and Healthcare Products Regulatory Agency (MHRA), UK
Switzerland became a third country to the EU on 26 May 2021 when the MDR came into force and the Swiss-EU Mutual Recognition Agreement (MRA) failed to be updated. All Swiss manufacturers must establish an authorised representative in the EU (EC-REP), and in return all foreign manufacturers need a Swiss authorised representative (CH-REP).
With the hurdles established by the Swiss Medical Device Ordinances, a quarter of the foreign manufacturers (1200 out of 5000 companies) decided not to establish a CH-REP and to stop trading. As a result, 15% of the imported medical devices (60’000 of 400’000 products) are no longer available to Swiss patients. It is now up to the importers and health professionals to urgently try and replace the missing products. To overcome the current supply challenge, Switzerland would urgently need a resolution of the outstanding institutional issues with the EU and an update of the MRA. This is doubtful in the short term.
To overcome (additional) future supply challenges, largely caused by the difficult implementation of MDR/IVDR, Switzerland would need more room to maneuver by accepting medical devices from non-European regulatory systems with comparable quality and safety. On 28 November 2022, the Swiss parliament has decided to adapt national laws so that (in addition to medical devices with a CE mark) medical devices with FDA approval shall also be recognised in Switzerland.