Update on the Implementation of the European Medical Devices Regulation and In Vitro Diagnostics Regulation
On May 26, 2017, the new European Medical Devices Regulation (MDR1) and In Vitro Diagnostics Regulation (IVDR2) entered into force. However, these regulations are not due to take effect until May 26, 2020 and May 26, 2022 respectively. In addition, the regulations include a derogation that allows companies to continue placing medical devices certified under the current Directives on the market for up to four years after the date of full application (i.e. up to May 26, 2024) if the notified body conformity certificate remains valid. There is, therefore, still time for companies to bring their product portfolio into compliance with the new rules.
However, there is much under these regulations that still has to be clarified before the full extent of their provisions can be implemented. The European Commission and Medical Device Coordination Group (MDCG) are busy preparing additional legislation and guidance to ensure the regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR/IVDR, and products can be placed on the market under the new regulations. There is still much to do, and progress has been slow. This is leading to uncertainty in the industry, and calls for extensions to the date of application.
We set out below an update on the current state of play.
What implementing legislation and guidance has been published?
The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. The Implementation Taskforce of the CAMD published a high-level MDR/IVDR Roadmap in November 2017,3 setting out how the regulations will be implemented, and the order in which key guidance and clarification documents will be developed. The Roadmap sets out a priority list of the issues that need to be addressed, and recommendations on who should take responsibility for addressing them. We understand that the intention is for items labelled as high priority (such as the common specifications for products that do not have a medical purpose, but will still be covered by the Regulation, such as coloured contact lenses or breast implants) to be finalized by the end of this year, while items labelled as medium priority (such as guidance on economic operators) will be finalized around the time of the date of application of the regulation. Items that are labelled as low priority (such as guidance on companion diagnostics) will be developed in due course. This timetable alone indicates that much of the necessary detail to ensure the full operation of the regulations will not be put in place while companies seek to prepare for May 2020.
In addition, the European Commission (the Commission) has published a "rolling plan" for the implementation of the MDR and IVDR,4 which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play. This indicates that the Commission, at least, believes the implementation timeline is on course for all the required elements to be in place by May 2020.
The Commission has recently updated its website to collate all of its guidance on the new legislation so it acts as a key portal for companies monitoring developments. The number of guidance documents has increased over recent months, with new information on EUDAMED (a database intended to contain much of the information on medical devices, as well as being a portal for data submission and vigilance reporting), unique device identifiers (UDIs) and notified bodies in particular.
What about notified bodies?
The first implementing act under the MDR and IVDR was published in November 2017 relating to the notified body product codes for medical devices and IVDs.5 Only notified bodies that have been designated under the regulations can carry out conformity assessment procedures, and only for certain types of devices, listed by the product codes in their designation.
As of July 1, 2019, the number of notified bodies that have applied for designation under the MDR and IVDR was as follows: 41 under the MDR and 10 under the IVDR (this is compared to the 58 currently designated notified bodies). The Commission has stated that the entirety of MDR and IVDR product codes are covered, although it is unclear how much overlap there is between notified bodies. At the recent MedTech Europe (the European trade association representing the medical technology industry) conference in Brussels, one of the biggest concerns for companies and regulators alike was the state of notified body designations under the MDR and IVDR. It has been estimated by the Commission that up to 20 notified bodies could be designated by the end of the year, but there is some scepticism about whether this is possible, or even if it is, whether there will be sufficient notified bodies to deal with all the devices that need to go through the new process before May 2020.
Further, there are reports that some notified bodies are not accepting new applications under the current medical device Directives (which would enable a longer transitional period under the MDR), or will not seek designation under the MDR/IVDR. In June 2019, the London-based notified body Lloyd's Register Quality Assurance (LRQA) announced that it will withdraw its notified body services under the current medical device Directives, and will not apply to be a notified body under the MDR or IVDR. This is likely to cause concern for IVD manufactures in particular, as LRQA is one of the notified bodies that processes a large number of the currently CE certified IVDs in the EU (CE stands for "Conformité Européene", the European Conformity assessment mark). The Swiss notified body QS Zürich AG has also decided that it will not pursue designation under the MDR, and there have been reports that a similar decision may be taken by the only Spanish notified body, AEMPS.
So far, only BSI UK and TÜV SÜD have been designated under the MDR, although these are two of the biggest notified bodies that are responsible for a large proportion of the certificates under the medical device Directives. Nevertheless, at present, there is a large capacity gap.
Will there be an extension to the transitional period?
In July 2018, MedTech Europe published a position paper calling on the Commission, the European Parliament and the EU Member States to extend the transitional period under the MDR and IVDR due to the "significant concerns" about the state of implementation of the regulations, and the fact that if products are not re-certified before the date of application of the regulations, they may not be able to continue to be placed on the market. MedTech Europe, together with seven other European Trade Associations, raised similar concerns in June 2019, and called on the Commission and the Member States to accelerate the implementation of the new regulatory system.
However, the Commission's response has been to state that the current deadline is "realistic and achievable". The European Commissioner for Health and Food Safety also said that preparation of the EUDAMED database core modules is on track to be functional in line with the current deadlines, and the establishment of the UDI system and work on implementing acts are close to being finalized. As such, while the Commission has recognised that the new regulations could have consequences for the availability of medical devices for health institutions, with the potential for some devices to "become temporarily unavailable", it does not seem to have current plans to delay the date of application.
Due to the lack of acceptance of the difficulties involved for companies, in July 2019, MedTech Europe asked CEOs of European companies and European-level leaders of global companies to co-sign a letter to national Ministers expressing concern over the implementation status of the MDR, and in particular, the lack of notified body capacity, and the risk this presents to the continued supply of products to patients. We understand that 135 signatures were gathered, and the letter has now been sent to Ministers of Health across Europe. The industry will have to wait to see if their concerns are taken on board.
What about Brexit?
Brexit, of course, adds a further layer of complication for companies. UK notified bodies currently certify a disproportionate number of devices that are on the EU market, and the UK acts as a gateway to the EU for many US clients. The UK government and regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA), have stated that if the UK leaves the EU without being able to reach a deal on the continued relationship between the UK and EU (no-deal), CE-marked medical devices that have been certified by an EU27 notified body will be recognised and able to be placed on the market in the UK. However, the Commission is taking a much more hard-line approach, and has said that devices certified by a UK notified body will not be able to be placed on the EU market without complying with the importation requirements under the EU legislation.
BSI UK has sought to prepare itself and its clients, having obtained notified body status under the current medical device Directives and under the MDR and IVDR through a Dutch subsidiary. This will mean that certificates can be transferred to the Dutch entity without going through a re-certification procedure to enable them to continue to be placed on the market post-Brexit.
In terms of the MDR and IVDR themselves, the UK government has stated that it intends to implement the regulations as much as possible within its capacity. Of course, whether the UK will have access to the EUDAMED database or other EU-wide systems to enable the full operation of the regulations remains to be seen.
What can you do in the meantime?
This is clearly a period of great uncertainty for medical device companies selling their products in the EU. Companies are facing the reality of having to comply with regulations that are not yet fully operational, and for which there are a number of gaps in the detail. Regulatory authorities have some sympathy with this, but the Commission is (currently) steadfast in its position that no additional time is required for implementation.
In practice, companies will have to make their own determinations on what needs to be put in place under the regulations, and how certain provisions operate. It will be for the company to assess its products and put together the justification as to why the product meets the new requirements, whether in terms of data to support conformity assessment, the quality management and post-marketing surveillance systems to be put in place, or executing amendments to existing contracts with economic operators. Clearly, it will be important for companies to work closely with their existing notified body to ensure current certificates under the medical device Directives are in place so companies can benefit from an extended transitional period. This will also ensure your company is not "back of the queue" when the notified body is considering which products to assess under the MDR.
If companies feel strongly about the size of the task needed to become MDR compliant before May 2020, it would also be worth engaging with industry bodies, both nationally and at EU-level, so that those concerns are brought to the attention of the Commission. It currently seems unlikely that, unless the Commission believes the concerns are felt throughout the industry, there will be any movement on the current dates.
© Arnold & Porter Kaye Scholer LLP 2019 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation 2017/745 and in vitro diagnostic medical devices under Regulation 2017/746.