General overview of the MDR/IVDR and their importance
On 26 May 2021, the regulatory framework for medical devices will change significantly. Although Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) entered into force on 25 May 2017, their application has not yet taken place. The MDR will apply from 26 May 2021 and the IVDR from 26 May 2022. Those are the dates you should be sure to take note of.
So far, medical devices within the EU have been regulated by three Directives (the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD); the Medical Device Directive 93/42/EEC (MDD); and the in vitro Diagnostic Medical Devices Directive 98/79/EC (IVDMD)) and by local laws. Now everything is going to change. In a similar way to the notorious GDPR, the MDR and the IVDR are directly applicable to all persons/entities in the EU, and in some cases also to persons/entities located outside the EU. And, again similarly to the GDPR, the MDR and the IVDR establish many new definitions and obligations and make requirements stricter for market participants.
The purpose of the new regulation introduced by the MDR and IVDR is to increase safety and efficiency in the EU medical device market, including improving the conformity assessment procedure for medical devices, as well as the competences of notified bodies. The aim is to make regulation clearer and more consistent throughout all EU Member States, and to strengthen cooperation between the Member States’ authorities in the field of market surveillance.
Some examples of the new rules established by the MDR and the IVDR:
- Every natural or legal person in the supply chain that makes a device available on the market, up to the point of putting it into service, will be defined as a ‘distributor’ of the medical device. This means that even a small kiosk selling plasters will become a distributor of medical devices and will have to comply with MDR.
- Every manufacturer of medical devices will have to have within their organisation (or permanently and continuously at their disposal) at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. This means that most manufacturers will be obliged to create an additional position for such employee – ie, bear additional employment costs.
- Any natural or legal person may find itself assuming the obligations incumbent on manufacturers if it modifies a device that has already been placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. Neither the MDR nor the IVDR explains exactly what the phrase “may be affected” means. This remains to be decided, probably in the courts.
- Every manufacturer, importer and distributor must be able to identify the following to the competent authority, for the previous 10–15 years:
- o any economic operator whom they have directly supplied with a device
- o any economic operator who has directly supplied them with a device
- o any health institution or healthcare professional whom they have directly supplied with a device
- Both importers and distributors must keep a register of complaints, of non-conforming devices and of recalls and withdrawals, keep the manufacturer informed of this monitoring and provide them with any information upon their request. Neither the MDR nor the IVDR elaborate on the storing period for this “register of complaints”.
- The new European Databank on Medical Devices (EUDAMED) will be created. EUDAMED has been in existence for many years but was previously only accessible by the European Commission and the National Competent Authorities. Now it will become mandatory to include all medical devices in this register.
- The MDR and the IVDR introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). Similarly as for medicines, every medical device will now have to have a unique “code”.
- The MDR regulates medical devices which traditionally are not considered for medical purposes, such as non-corrective contact lenses, and substances for use as fillers for the face or other parts of skin by subcutaneous injection.
- Classification rules for medical devices as well as for in vitro diagnostic medical devices are revised.
We could continue for pages. Both regulations provide around 200 pages of interesting, but complicated reading. All market participants should start reading now, if they would like to be ready for 26 May 2021. We can provide some assistance here. Sorainen Estonia organised a webinar on 18 February 2021, during which the MDR and the IVDR were introduced by our legal experts and by a representative of the Estonian Health Board. A recording of the webinar is available here in Estonian.
In-house medical devices
One of the biggest changes in the MDR and the IVDR concerns so-called in-house medical devices. Until now, healthcare providers enjoyed wide exemptions from the usual requirements applicable to medical devices. This was especially the case with in vitro diagnostic medical devices produced and used only within the facilities related to the production activities of the relevant healthcare provider. In these cases, the device did not have to be registered and the authorities did not even have to be notified about the use of this medical device. The end of that era has now arrived.
Article 5(5) of both regulations establishes that devices that are manufactured and used within health institutions will be considered regular devices unless they fulfil all the conditions envisaged by that clause. Those conditions are strict, and even if one condition is not completely met, the healthcare provider must comply with all the obligations applicable to medical devices manufacturers.
Among the trickiest conditions are the following:
- The devices must not be transferred to another legal entity (ie, the devices cannot be used by any other healthcare providers, and the results obtained from any specific device can be used only within that healthcare institution).
- The health institution must prove that the target patient group’s specific needs cannot be met, or cannot be met at an appropriate level of performance by an equivalent device available on the market (ie, if a similar medical device or a device with a similar effect is sold on the EU market already, the health institution cannot use its existing product).
- The health institution must draw up a declaration about each such medical device and make it publicly available. The declaration must include detailed information about the device.
The change in the approach to in-house medical devices increases health institutions’ burden quite significantly, both workwise and budget-wise. Many hospitals and research centres have used in-house medical devices (eg software used for analysing blood samples) for years without the need to analyse whether they could purchase a similar device/service from the market. Now they have to do so. And if they find such a device, they either have to purchase it or become manufacturers of medical devices themselves and so carry all the obligations applicable under the MDR/IVDR.
Country-specific rules applicable from 26 May 2021
To a certain extent, both the MDR and the IVDR leave some issues to Member States’ discretion. Regarding those issues, each country will adopt its local laws. Please find below our brief overview of the local peculiarities in the Baltic countries, as far as these are currently known and available.
Estonia has already adopted the new Medical Devices Act (MDA), which will enter into force on 26 May 2021 and is available in English here. Subsection 1(2) of the MDA establishes that MDA willl not apply to medical devices in the cases where the MDR is applied. Basically, this means that the MDR applies in all cases except in cases where the MDR envisages that local laws must elaborate the requirements of MDR (eg aspects of clinical investigation of medical devices).
The MDA has not, however, taken into account the requirements deriving from the IVDR; the clauses concerning in vitro diagnostic medical devices have remained unchanged. This is due to the fact that the IVDR will apply only from 26 May 2022. In an explanatory note to the MDA, it is stated that the act requires further amendments in connection with the IVDR, but they will be made by 26 May 2022. Until then, the use of in vitro diagnostic medical devices is regulated by the MDA.
The Estonian Health Board has also gathered some information concerning the MDR and the IVDR on its webpage.
Currently the Ministry of Health is working on new draft regulations that would replace Cabinet Regulation No. 686 Procedures for Registration, Conformance Assessment, Distribution, Operation and Technical Supervision of Medical Devices. It is expected that at least half of the contents of the current Cabinet regulation No. 686 will be changed, therefore it has been decided to adopt a completely new version. Since Cabinet Regulation No. 686 largely covers the scope of the MDR and the IVDR, the new draft regulations are meant to abolish the national norms that overlap with the MDR and the IVDR. Therefore, the MDR and the IVDR will apply in all cases, except when the EU regulation envisages application of national requirements. The draft regulations are at the very beginning of development, and it is still unknown when they will come into force.
In order to ensure an appropriate level of safety for patients and users in smaller healthcare facilities, the draft regulations maintain the obligation of the manufacturer, its authorised representative, and bodies accredited by the national accreditation body to carry out technical supervision of medical devices. Technical supervision may be performed only by authorised representatives of the manufacturers who are expressly entitled to perform functional and electrical safety inspections of the relevant medical devices.
The draft regulations also prohibit the exploitation of classes IIa, IIb and III of active medical devices from1 January 2023. The prohibition does not apply to medical devices for which a permit has been received in accordance with the specified procedures.
As well as this, the draft regulations introduce the recycling and reuse of single-use medical devices in Latvia, which is directly permitted and partly regulated by Regulation 2017/745. The provisions of the draft regulations are based on the current regulation in Germany and the United Kingdom on the recycling and reuse of single-use medical devices. Essentially the project for the reprocessing of single-use medical devices imposes the same requirements as Regulation 2017/745 for the manufacture of medical devices. Namely, these requirements are very demanding, difficult and resource-consuming to meet. The recycling of single-use medical devices can be economically justified only for relatively expensive and complex devices (such as harmonic scalpels, laser sutures, etc).
Additionally, the State Agency of Medicines is the supervisory authority of medical devices in Latvia. It has prepared informative material explaining the changes brought by MDR and IVDR (available in Latvian). Additionally, the State Agency of Medicines has created a specific e‑mail address – [email protected] – for inquiries and clarifications on the applicability of the MDR and the IVDR regarding the Latvian market.
Both EU regulations are directly applicable, therefore, the market participants must follow the requirements provided in the MDR and the IVDR for product conformance in the Lithuanian market.
In general, most of the changes to local regulations in Lithuania are related to implementing the MDR (as the IVDR will come into effect later). In most cases local laws are being amended in a “technical way” to indicate direct references to the MDR (instead of the previously valid local laws on implementing the MDD). Also, some local laws are adjusted to the MDR regulation, where necessary. In addition, all local regulations previously intended for implementing the MDD have been abolished. All the changes to the local regulation will take effect on 26 May 2021. At the moment, neither the Ministry of Health nor the parliament have proposed planned changes to the regulations which would imply something considerably different or new from to the MDR or IVDR.
Additionally, the State Health Care Accreditation Agency, the supervisory authority for medical devices in Lithuania, has prepared a sample list of new requirements adopted in the MDR and the IVD, as well as a summary explaining to producers, importers and healthcare institutions the relevant changes introduced by the MDR and the IVDR, and material relevant for public procurements of medical devices (available here in Lithuanian).
Action plan for companies
As always, deadlines come around unexpectedly quickly. Both the MDR and the IVDR establish many additional requirements which must be considered, and which require quite extensive preparations and preliminary work. Here is our brief action plan for companies who deal in some way with medical devices. This plan should be implemented as soon as possible because 26 May is just around the corner!
- Map your company’s exposure to medical devices:
- Does your company use any medical devices in its business activities? Eg do you provide healthcare services? Do you sell medical devices (eg face masks, contact lenses, pregnancy tests)?
- Are those medical devices regular devices or in vitro diagnostic medical devices?
- Is your company a manufacturer of those devices? Or an authorised representative? Or an importer? Or a distributor? Or a user?
- Check the qualification of medical devices in the light of the MDR and the IVDR.
- Review the obligations that apply specifically to your company depending on the activities:
- o General obligations of the manufacturer (MDR/IVDR Art 10; Art 15; etc)
- o General obligations of the authorised representative (MDR/IVDR Art. 11; Art. 12; Art. 15 (6); etc)
- o General obligations of the importer (Art 13; Art 16; etc)
- o General obligations of the distributor (Art. 14; Art. 16; etc)
- o Obligations, which apply to users of the medical devices (Art 16)
- Establish and implement the necessary systems to support compliance with the obligations applicable to your company, depending again on your role in relation to the particular medical devices (eg risk management system; quality management system, including post-market monitoring system, etc).
- Consult with local authorities or your legal advisor if you have questions or concerns!
Rules for medical device distribution in Belarus
Unlike in the EU, at the moment in Belarus there is no general policy regarding changing legislation related to medical devices. Still we have some expectations in this regard, as 2020 was a busy year for active legal amendments to pharmaceuticals regulations. What will happen next?
In light of this, below we have highlighted the key features of medical devices regulation. These regulations may apply if, for example, an EU manufacturer of medical devices decides to enter the Belarusian market.
Entering market and distribution
First of all, please note that obtaining a special approving document (eg a licence) for the distribution of medical devices is not necessary.
Nonetheless, entering the Belarusian market and the distribution of medical devices are subject to certain formalities. Namely, distribution of medical devices requires their registration at national level (in Belarus) or supranational level (in the EAEU). Currently (and until 31 December 2021) it is possible to choose the form of registration: national or supranational. After 31 December 2021, only supranational registration will apply.
At the moment, national registration is to the best of our knowledge the more common practice. So below we have described the step-by-step plan for national registration of medical devices:
1) applying for registration, if the medical devices fall under the following categories:
- created in Belarus and being launched there for the first time
- manufactured in other countries and being launched in Belarus for the first time
- similar to others that have been registered, but produced by a different manufacturer
- previously registered, in the case of a new production site being added
- included in other medical devices, but used separately
2) conducting preliminary technical work (including initial examination of documents, inspection of manufacturing, sanitary hygienic trials, clinical trials, etc) based on an agreement with the regulatory authorities – this work is intended to check the safety, quality and efficacy of medical devices
3) paying the state for registration – a fee of approximately EUR 95 (as of 5 March 2021)
4) registering and issuing a marketing authorisation, whose initial term of validity is five years. Afterwards, the marketing authorisation can become perpetual if the medical device is re-registered.
Belarusian law establishes general advertising regulations and describes specifics related to advertising medical devices. General requirements for any advertisement cover, in particular, its form, language, contents and details of the advertiser. As to specifics, for example, advertising of medical devices, as a general rule, can occur with the approval of the Ministry of Healthcare and provided the advertiser has marketing authorisation. Specific rules also prohibit advertising of unregistered medical devices (except for advertising their clinical trials, and then only for the purpose of attracting volunteers to participate in them).
On 8 July 2021, some amendments concerning advertisement of medical devices will enter into force, such as:
- The scope of medical advertisements subject to approval by the Ministry of Healthcare is reduced – for example, outdoor advertisement and advertisement on vehicles will not require mentioned approval.
- Discounts are permitted to be mentioned in medical advertisements in case the advertised object can be purchased with such discounts, etc.
It must be also taken into account that Belarusian law regulates the setting of prices for medical devices via limiting mark-ups for wholesale and retail. These limitations relate to medical devices of both Belarusian and foreign origin.
As to medical devices of foreign origin, relevant mark-ups depend on the total estimated selling price and the particular type of medical device. Wholesale mark-ups vary from 3% to 20%. Retail mark-ups vary from 0% to 30%. The formula for such prices is as follows:
Estimated selling price = contract price + customs fees + import VAT + transport expenses
Please see below for formulas for wholesale and retail price setting:
Wholesale price = estimated selling price + wholesale mark-up
Retail price = wholesale price + retail mark-up