Last year the European Commission acted to delay the implementation of the new Medical Devices Regulation in order to allow the medical device industry to focus on the Covid-19 crisis. The changes which were due last May are now due to come into force on 26 May 2021. The UK has announced that it will not implement the new Regulation but will bring forward its own proposals. Meanwhile, medical device manufacturers selling into the UK market have until June 2023 to bring their products into line with the new UKCA requirements. This article discusses upcoming changes to the medical device regime in both the UK and the EU.
Medical devices have long been one of the more complex fields of CE marking but hitherto, most of the challenges have been technical or clinical. However, changes brought about by the implementation of a new EU Regulation, and in Great Britain by Brexit, mean that we are now looking at a couple of years of disruption and change to the administrative aspects of the medical device rules.
Terminology and timing
To start with, it’s important to get the terminology correct. There are three pieces of legislation relevant to this discussion.
- The Medical Devices Directive 93/42/EEC - the original European Directive requiring CE marking of medical devices. This is referred to below as ‘MDD”.
- The Medical Devices Regulations 2002 (Statutory Instrument 2002 No. 618) - the UK implementation of the MDD. Referred to below as SI 2002/618.
- The Medical Devices Regulation 2017/745/EU - The replacement for the MDD. It’s an EU Regulation (not a Directive) and hence takes direct effect in Member States of the EU (i.e. there is no need for an implementing Statutory Instrument in the UK). Referred to below as the MDR.
The MDR was due to take effect across Europe last May, but was delayed by 12 months to allow medical device manufacturers and regulators to focus their efforts on dealing with the Covid-19 crisis. It is now due to be implemented in Europe from 26 May 2021. Manufacturers who were CE marking under the MDD must update their procedures and documentation to meet the new requirements of the MDR by that date. Product which is already in the supply chain as of 26 May can continue to be sold until stocks are exhausted but all new product manufactured after that date will have to be certified to the new Regulation rather than the old Directive.
MDD to MDR changes
For class I devices the changes required to move from the MDD to the MDR should be fairly straightforward and will mainly consist of issuing a new Declaration of Conformity and ensuring that any references to the MDD in instructions and packaging are changed to refer to the MDR. However, for Class II and higher devices (and Class I devices supplied sterile or with a measuring function) this will require Notified Body certificates to be re-issued with the updated reference, and that in turn means that any supporting paperwork such as quality control procedures will also need to be updated. Additionally, Notified Bodies need to re-register with their national authority to have their notification updated, and changes in the way that Notified Bodies are qualified under the new Regulation mean that this is not simply a formality. It is expected that quite a few bodies which are Notified under the old Directive will not make it through the process to be Notified under the new Regulation. Given the lead times for medical device Notified Body services, it’s probably already too late for manufacturers to meet the May deadline if they have not already started working on this, even if they start on it tomorrow.
A further complication is that the Regulation is much more explicit (and demanding) about the content of the technical file for all classes of device, so manufacturers will need to put significant effort into updating their documents and procedures.
Originally, the UK government was planning to implement the MDR in the UK (since this would have been a requirement of the withdrawal treaty which applied in the UK from 31st January 2020 until 31 December 2020). Because the date of implementation of the MDR was delayed beyond the end of last year when the UK left the EU, the UK is now under no obligation to implement the MDR in UK law and, in fact in early January, the MHRA announced that they were not going to implement the MDR but would instead bring forward UK specific arrangements to update SI 2002/618.
As a consequence of Brexit, for product safety purposes the UK has been split into two parts: Great Britain (England Scotland and Wales) has left the single market and so CE marking no longer applies. Northern Ireland remains in the single market and so products sold there continue to need CE marking just as they did before Brexit.
As an alternative to CE marking, a new mark, the ‘UKCA mark’ will be required in GB. The UKCA mark is a direct replacement for the CE mark, and until UK and EU product safety legislation starts to diverge in years to come, the technical and administrative requirements for applying it are identical to those which apply to CE marking. For an introductory period (ending on 31 December 2021), most products which were previously CE marked can continue to be sold with a CE logo instead of a UKCA mark, but from the end of 2021 they will have to carry the UKCA mark as well as, or instead of, the CE mark. Medical devices have actually been given a longer transition period and have until 30th June 2023 before the CE mark will no longer be considered acceptable.
As already stated, the MDR comes into force in the EU on 26 May 2021, so manufacturers of medical devices who wish to CE mark their products after this coming May will need to comply with the MDR instead of the MDD. However, the UK government have decided that it makes no sense to force manufacturers who are simply using the CE mark as a way to put off having to apply the UKCA mark to have to comply with the MDR and they will continue to accept products CE marked under SI 2002/618 and the MDD until the 30 Jun 2023. It seems reasonable to expect that any new legislation replacing SI 2002/618 will be scheduled to coincide with this deadline. This results the rather bizarre scenario that there could be products which have a CE mark on them which makes them legal for sale in the UK but not in the EU! The UK has also said that they will accept products CE marked under the MDR until the 2023 deadline, and clearly this will be the preferred route for any manufacturer who wants to sell both in the UK and the EU.
Representation in the UK and Europe
The MDD has long been the only CE marking directive which requires a manufacturer who is not resident within the EU to appoint a single “Authorised Representative” (AR) to be responsible for product placed on the EU market.
The UK is now no longer part of the EU which means that any manufacturer who had previously appointed an AR based in the UK can no longer use them as the sole representative within the EU. If medical device manufacturers based outside Europe wish to sell in both the EU and the UK markets they now need two representatives: one based in the EU and one based in the UK.
Post-Brexit, the UK legislation now refers to a “Responsible Person” (RP) but in essence this is the same role as is fulfilled by the AR in the EU. As before, it’s important to note that the RP must be appointed by a written mandate from the manufacturer which lays out the roles and responsibilities on either side. This page https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible gives a summary of the RP’s obligations which are broadly similar to the requirements in Article 11 of the MDR.
The requirement to appoint an RP applies to all classes of medical device and all RP’s must register with the MHRA. This is in contrast to the current CE marking arrangements which only require class I device manufacturers to register. There are (fairly short) grace periods during which manufacturers are required to register:
Class I devices
Systems and procedure packs
Active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A products
Class IIb non-implantable medical devices
Class IIa medical devices
IVD List B products
Should already be registered
Must be registered by 30 April 2021
Must be registered by 31 December 2021
The requirement to appoint an RP and register applies to all UKCA and/or CE marked devices.
Additional requirements under the MDR
This article is primarily focused on the changes required as a result of Brexit but the administrative changes required by the transition from the MDD to the MDR are at least as significant. In particular, the requirement to register all manufacturers of all classes of device is not just UK specific, and the MDR also contains requirements for the registration of importers in addition to manufacturers and authorised representatives. Furthermore, medical devices themselves will have to have a unique identifier and a pan-European database (“Eudamed”) will include publicly available information about all devices including their certification and clinical investigations. It remains to be seen how much of this makes its way into the new UK Regulations.