According to the data of the Office of Large Taxpayers of the State Tax Service, the taxpayers in May 2020 declared to pay UAH 10.9 billion of value added tax, which is 1.8 billion UAH or 19.6% more than in April 2020. At the same time, the volume of transactions on the territory of Ukraine increased by only 2.3% compared to the previous period.

The tax return on WFP Office payers also increased significantly compared to the same period last year, an increase of 1.01 percentage points to 4.07%.

Also, it should be noted the monthly stable increase in tax returns in the current year:

-March – 3.16%

-April – 3.48

-May – 4.07%

The largest contribution to the filling of the budget for the payment of value added tax on the declaration for May 2020 was provided by enterprises of such sectors of the economy as:

• wholesale and retail trade – UAH 2.1 billion, which is UAH 404.6 million, or 23.3% more than the results of financial and economic activities in April 2020 (UAH 1.7 billion).
• processing industry – declared UAH 2.2 billion, which is UAH 357.5 million or 18.8% more VAT accruals for the previous reporting month (UAH 1.9 billion).

In the first five months of 2020, large taxpayers declared almost UAH 52 billion in value added tax and provided an increase of UAH 5.8 billion or 12.8% compared to the corresponding period of 2019.

During January-May 2020, due to a significant increase in accrued tax liabilities relative to the volume of taxable transactions, the tax return is steadily increasing compared to last year (3.28%) and is – 3.56%.

On May 18, the Resolution of the Cabinet of Ministers of April 22, 2020 № 341 came into force, which defines the mechanism for declaring changes in retail prices for goods of significant social significance and anti-epidemic goods.

Declaration of changes in retail prices is introduced in case of price increase, compared to the price on the date of entry into force of this resolution or pre-declared price (except in cases of price increase due to expiration of the discount or price reduction).

In this regard, the State Food and Consumer Service has prepared answers to the most common questions from businesses and citizens about the procedure for declaring prices.

The Cabinet of Ministers of Ukraine adopted a resolution dated 22.04.2020 № 341 “On measures to stabilize prices for goods of significant social significance, anti-epidemic goods”, which temporarily introduces state regulation of prices for goods of significant social significance and anti-epidemic goods by declaring changes in retail prices in the event of an increase.

The State Food and Consumer Service has prepared answers to the most common questions from businesses and citizens about the procedure for declaring prices.

When does the Resolution enter into force and for how long will it be in force?

In accordance with paragraph 3 of the Resolution, it enters into force ten days after its publication and is valid until the end of the quarantine established by the Cabinet of Ministers of Ukraine from 11.03.2020 № 211 “On prevention of acute respiratory disease COVID-19 caused by coronavirus SAR CoV-2 ».

The resolution was published on May 8, 2020 in the newspaper “Governmental Courier” № 87, and therefore on May 18, 2020 it enters into force.

Which goods are subject to declaration?

The decree approved exhaustive lists of goods of significant social significance and anti-epidemic goods, which are necessary to prevent the spread of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2, the price of which will be declared. For medicines included in the list, changes in retail prices are declared by trade names of drugs.

In which case should an entity declare a change in price?

From the moment of entry into force of the Resolution, if the business entity sells goods that have significant social significance or belong to anti-epidemic goods, and plans to increase the retail price by 5 percent or more against the retail price at the time of entry into force of the Resolution, declaring price changes. In the future, it is necessary to declare a change in the retail price in the event of an increase of 5 percent or more against the already declared retail price.

Does the entity have to declare a change in wholesale prices?

No. Only changes in retail prices are subject to declaration.

Is it necessary to declare a change in the retail price as of 18.05.2020?

No need. The declaration of change in retail prices for goods is made by the business entity in the event of an increase in the retail price of goods sold, compared to the retail price on the date of entry into force of the Resolution.

Do I need to declare a retail price increase of less than 5 percent?

No. Prices that increase by 5 percent or more are subject to declaration.

When can the declared retail prices be applied?

In accordance with the requirements of the Resolution, the beginning of the application of the declared retail prices depends on the percentage of their increase, namely:

• in case of price increase by 15 percent and more – the application of the retail price is possible not earlier than in 30 days, without taking into account the day of declaration;
• in case of price increase by 10 percent and more, but less than 15 percent, the application of the retail price is possible not earlier than in 14 days, without taking into account the day of declaration;
• in case of price increase by 5 percent and more, but less than 10 percent, the application of the retail price is possible not earlier than in three days, without taking into account the day of declaration.

The price increased by more than 5 percent due to the expiration of the discount. Do I need to declare a change in prices?

No need. In cases where the increase in prices was due to the expiration of discounts, it is not necessary to declare a change in prices. The retail price, which is increased by 5 percent or more, which was in effect before the introduction of the discount, is subject to declaration.

How will the procedure for declaring a change in retail prices take place?

Declaring changes in retail prices for goods will be done electronically by submitting information using a qualified electronic signature to the State Food and Consumer Service through its official website / link / (the link will be active from May 18, 2020).

When will the information on the declared price changes be included in the Register of retail prices for goods?

After successful registration of data, the information will be immediately entered into the Register of retail prices for goods automatically without the participation of officials of the State Food and Consumer Service.

Who will have access to the Register of retail prices for goods?

The State Food and Consumer Service will place the Register of retail prices for goods on its official website and provide free, round-the-clock and free access to its information.

Where can I find the Register of retail prices for goods?

The Register of Retail Prices is available on the official website of the State Food and Consumer Services at the link –

https://declaration.consumer.gov.ua/superset/dashboard/%D0%A0%D0%B5%D1%94%D1%81%D1%82%D1%80-%D1%80%D0%BE%D0%B7%D0%B4%D1%80%D1%96%D0%B1%D0%BD%D0%B8%D1%85-%D1%86%D1%96%D0%BD/. 

Is it a violation to apply retail prices, increased by 5 percent or more after the entry into force of the Resolution, without following the declaration procedure?

So from 18.05.2020 sale of goods of significant social significance, anti-epidemic goods, the lists of which are approved by the Resolution, at a retail price increased by 5 percent or more without the procedure of declaring price changes, is a violation of requirements for the formation, establishment and application of state regulated prices.

What is the liability for non-compliance with the procedure for declaring retail prices?

Administrative and economic sanctions are applied to business entities that commit this violation in accordance with Article 20 of the Law of Ukraine “On Prices and Pricing”.

Also, citizens (individuals-entrepreneurs) and officials of economic entities for violation of the order of formation, establishment and application of prices and tariffs, are brought to administrative responsibility by imposing fines in the amounts specified in Article 1652 of the Code of Administrative Offenses.

Resolution of the Cabinet of Ministers of Ukraine of April 22, 2020 № 341 “On measures to stabilize prices for goods of significant social significance, anti-epidemic goods“, will enter into force on Monday, May 18, 2020.

This resolution, in particular, provides for the approval of:

• list of goods of significant social significance (10 items of food);
• list of anti-epidemic products necessary to prevent the spread of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2;

This list consists of 7 items of medicines, 11 items of antiseptics and disinfectants, 20 items of personal protective equipment.

• Procedure for declaring changes in retail prices for goods of significant social significance and anti-epidemic goods necessary to prevent the spread of acute respiratory disease COVID-19 caused by the coronavirus SARS-CoV-2.

The requirement to declare a change in price is imposed only on economic entities that carry out retail trade in goods from the lists above.

The change of retail prices (including VAT) for each separate type of goods is subject to declaration, regardless of the type of its packaging (except for goods, the type of packaging of which is defined in the list of goods of significant social significance approved by the Cabinet of Ministers of Ukraine of April 22, 2020). 341), weight (volume) of a unit of goods, dosage, form of release, and any other features.

Declaring the change in retail prices for goods is carried out by the business entity in relation to the object (institution) of retail trade in case of increase of the retail price for goods sold by such object (institution), compared with the retail price on the date of entry into force of the Cabinet of Ministers from 22 April 2020 № 341 (18 May 2020) or with a pre-declared retail price (except in cases of a price increase due to the expiration of the discount or price reduction):

• 15 percent or more – 30 days before the application of the declared retail price, excluding the day of the declaration;
• by 10 percent or more, but less than 15 percent – 14 days before the application of the declared retail price, excluding the day of the declaration;
• 5 percent or more, but less than 10 percent – three days before the application of the declared retail price, excluding the day of declaration.

Declaring changes in retail prices for goods is carried out electronically by submitting information to the State Food and Consumer Service through its official website using a qualified electronic signature.

This information will be automatically entered free of charge into the Register of retail prices for goods, which is maintained electronically by the State Food and Consumer Service.

This resolution shall enter into force ten days after its publication and shall remain in force until the end of the quarantine established by the resolution of the Cabinet of Ministers of Ukraine of March 11, 2020, № 211 “On prevention of the spread of acute respiratory disease COVID-19 caused by SARS-CoV-2 ”.

On the 15th of May, 2020, the State Food and Consumer Service of Ukraine published an explanation on this issue, in which it provided answers to typical questions, however, in this publication, the State Tax Service did not mention anything about medical devices.

An explanation is available at the link.

The declaration will be made on a special website of the State Tax Service, which will be operational from 18.05.2020 https://price.consumer.gov.ua/.

The price register will be available at the link.

According to the information posted on the official website of the Cabinet of Ministers of Ukraine at https://www.kmu.gov.ua/npas/pro-vnesennya-zmin-do-deyakih-postanov-kabinetu-ministriv-ukrayini-347060520, 06 On May 2020, at the regular sitting of the Cabinet of Ministers of Ukraine, the Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” № 347 (hereinafter – the Resolution of the Cabinet of Ministers № 347) was adopted.

The Cabinet of Ministers of Ukraine (CMU) by Resolution of 06.05.2020 № 347 amended the resolutions approving the technical regulations № 753, №754 and №755.

Thus, these three resolutions are supplemented by new paragraphs of the following content in terms of recognition by the conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies:

№ 753 –

«2.5. To establish that the introduction into circulation and / or operation of medical devices / systems of medical devices / procedural sets purchased by a person authorized to make purchases in the field of health care, in accordance with the list determined by the Cabinet of Ministers of Ukraine, in respect of which 15–19 of the Technical Regulation approved by this Resolution shall be permitted subject to the recognition by the designated conformity assessment body of the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with requirements of parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”. “;

№ 754 –

«2.2. To establish that at the time of the Law of Ukraine “On Amendments to Certain Laws of Ukraine Concerning Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Organizations Carrying Out” for in vitro diagnostics, which are subject to procurement in accordance with procurement agreements concluded by the Ministry of Health with specialized procurement organizations, which are not performed in The requirements of paragraphs 10-13 of the Technical Regulations approved by this resolution are permitted provided that the designated conformity assessment body recognizes the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with the Law of Ukraine in accordance with Article 45 and compliance ».»;

№ 755 –

«2.4. To establish that the introduction into circulation and / or operation of active implantable medical devices, which are purchased by a person authorized to make purchases in the field of health care, in accordance with the list determined by the Cabinet of Ministers of Ukraine21 for which the requirements 19 The technical regulations approved by this resolution shall be permitted provided that the designated conformity assessment body recognizes the results of the conformity assessment carried out by foreign accredited conformity assessment bodies in accordance with the requirements of parts per. second and third of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment.”

In addition, a number of points were set out in the updated version:

№ 753 –

23. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation medical devices to be procured in accordance with procurement agreements concluded by the Ministry of Health with specialized procurement organizations for which no The requirements of paragraphs 15-19 of the Technical Regulations approved by this resolution are allowed provided that the designated conformity assessment body recognizes the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with the requirements of parts one and three of Article 45 of the Law of Ukraine “On Technical Regulations and conformity assessment ”;

№ 754 –

2.2. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation in vitro diagnostic medical devices to be procured in accordance with procurement agreements entered into by the Ministry of Health with specialized procurement organizations in respect of which the requirements of paragraphs 10-13 of the Technical Regulation approved by this resolution are not met, is allowed subject to recognition by the designated conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”;

№ 755 –

2.2. To establish that during the Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” the introduction into circulation and / or operation active implantable medical devices subject to procurement in accordance with procurement agreements entered into by the Ministry of Health with specialized organizations Invoices for which the requirements of paragraphs 19-21 of the Technical Regulation approved by this resolution are not met are allowed subject to recognition by the designated conformity assessment body of the results of conformity assessment conducted by foreign accredited conformity assessment bodies in accordance with parts one and three of Article 45 of the Law of Ukraine “On technical regulations and conformity assessment”.

In the text of the technical regulations, the reference norms were replaced by the Law of Ukraine “On the Principles of the State Language Policy” instead of the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language”.

Resolution № 347 was adopted at the Government meeting on May 6, despite the absence of this issue on the agenda published on the official website of the Cabinet of Ministers of Ukraine at the following link https://www.kmu.gov.ua/meetings/zasidannya-kabinetu-ministriv-ukrayini-05-05-2020.

Resolution of the Cabinet of Ministers № 347 is a regulatory act and has a wide range of actions.

Resolution of the Cabinet of Ministers № 347 was not submitted for public discussion and was not made public until its adoption by the Government of Ukraine.

Resolution of the Cabinet of Ministers № 347 shall enter into force on the day of its publication. A number of its items, namely sub-item 1 of item 1, sub-item 1 of item 2 and sub-item 1 of item 3 of the changes approved by this resolution, have limited scope in time and will operate until March 31, 2022.

The Resolution of the Cabinet of Ministers № 347 has not been officially published yet.

The Cabinet of Ministers of Ukraine supported the resolution on the list of goods not covered by the ban provided for in Article 54 of the Law of Ukraine “On Prevention of Corruption”, which will allow a number of executive bodies to receive free medical and anti-epidemic goods during the quarantine.

Previously, Article 54 of the relevant law completely prohibited the receipt of benefits, services, and property by public authorities and local governments.

According to the Minister of Justice Denis Malyuska, the list includes medicines to provide medical care to patients with COVID-19, disinfectants and antiseptics, medical equipment for health care facilities that provide care to patients with COVID-19, personal protective equipment, medical devices for screening patients, consumables for medical care for patients with COVID-19, medical devices, laboratory equipment, consumables, reagents for laboratory tests, medical devices would (consumables) for pathology departments, vehicles for health care facilities of the emergency medical care system and sanitary aviation (aviation medicine).

These goods can be voluntarily transferred to the central executive body that implements the state policy in the field of health care, to other central executive bodies that implement state policy in the areas of sanitary and epidemiological well-being, quality control, and safety of medicines, HIV prevention. infections / AIDS and other socially dangerous diseases, and structural units for health care of regional, Kyiv and Sevastopol city state administrations.

With this publication in the Official Journal of the European Union, the one-year postponement to the go-live date for the EU Medical Device Regulation and extension of validity of the Medical Device Directives became a done deal.

The important final step for the extraordinary measure came with just over a month to spare before the regulation would have taken force, and almost exactly a month after the European Commission announced plans to introduce the delay in light of disruptions from the coronavirus pandemic.

The Parliament and Council nearly unanimously greenlighted the postponement.

The past month has been marked by cautious optimism that a formal MDR delay would speed through the necessary regulatory path prior to the original May 26 start date. Now that the measure, which regulators said was needed to allow medtech manufacturers to focus on meeting market demands driven by the “unprecedented magnitude of the current challenges,” has been officially recorded in the EU journal, industry can breathe a collective sigh of relief.

“In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption, it is necessary to defer the application of certain provisions,” the amendment to legislation states.

It also says: “Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Unionwide derogations in response to national derogations in order to address potential Union-wide shortages of vitally important medical devices in an effective manner.”

Still, the one-year delay doesn’t solve the challenges for the relatively few notified bodies designated for MDR work. However, to avoid further bottlenecks, the MDCG is permitting notified bodies to conduct remote audits during the coronavirus outbreak.

The industry is also still waiting on other guidance from regulatory authorities. To that end, MDCG published a postmarket clinical follow-up plan and evaluation report template guides for manufacturers and notified bodies, as well as guidance on clinical evidence needed for medical devices previously CE marked under the Medical Device Directives and demonstrating equivalence.

Regulators have made it clear to date that despite their willingness to delay MDR enforcement, the In Vitro Diagnostic Regulation will still take force in 2022.

The Ministry of Economic Development, Trade, and Economy of Ukraine is using the UNICEF Representative Office in Ukraine to prepare a thematic issue Consensus Forecast “Ukraine in 2020-2021: Experiencing Pandemics”, which can be developed to cover consensus consideration that may be relevant to specific issues and professional issues. They set themselves the world economy and preceded economic Ukraine when reviews were known and limited results of work during the fight against the COVID-19 pandemic were presented in Ukraine.

According to experts, Ukraine shows a deep decline in 2020 – by 4.2%. In 2020, the growth of infrastructure to 7% against 4.1% (last year to December of the previous year) in 2019. However, in 2021 there was economic growth at 2.4%. Inflation reports up to 5.9% (from December to December of the previous year).

The full version of the program is available the following link https://www.me.gov.ua/News/Detail?lang=uk-UA&id=0b23329b-4ed1-4899-a968-e2b22e12830d&title=MinekonomikiOpriliudniloNoviiKonsensusprognozNa2020-2021-Roki.

According to the Ministry of Digital Transformation, online dashboards have been created that reflect reliable information on the fight against COVID-19 in Ukraine and inform about the availability of medical facilities with the necessary resources.

The dashboard is available online and is updated daily at the following link https://covid19.gov.ua/analitichni-paneli-dashbordy. 

Analytical panels of the portal (dashboards) were developed by a working group consisting of Deputy Ministers of Health and representatives of the State Enterprise “Medical Procurement of Ukraine”.

Dashboards contain information about medical institutions that are ready to receive patients, free beds and ventilators, stocks of personal protective equipment, medical staff, and more. The information can be viewed both in Ukraine as a whole and for individual regions and even – medical institutions.

“The portal allows you to live control of the situation with the provision of hospitals and respond quickly if necessary: ​​to supply drugs, equipment, staffing, etc. The portal also allows us to understand the real situation in the country and, I hope, this will stop the spread of fakes. Now everyone can go and check this or that information online,” said Mykhailo Fedorov, Vice Prime Minister of Ukraine and Minister of Digital Transformation.

The portal also provides up-to-date information on coronavirus quarantine and counteraction. An interactive map of state borders and information on crossing checkpoints will be available soon.

It is important that the portal contains public information in the form of open data so that everyone can freely receive, process, and publish it on their own resources, using reliable data from the original source.

The Government of Ukraine adopted the Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” of April 8, 2020 № 271, which entered into force on April 15, 2020 due to publication in the Government Courier (hereinafter – Resolution № 271).

Resolution № 271, in particular, amended the Medical Technical Regulations № 753-755 of 02.10.2013 and the Technical Regulations of Personal Protective Equipment, approved by the Resolution of the Cabinet of Ministers of Ukraine of 27 August 2008 № 761.

Thus, the new version sets out the norm of resolutions on approval of the above regulations, which establish the mechanism of putting into circulation products from the List № 224, in respect of which the requirements of the Technical Regulations are not met, for the period of paragraph 71 of subsection 2 of section XX “Transitional Provisions” Ukraine and paragraph 96 of Section XXI “Final and Transitional Provisions” of the Customs Code of Ukraine.

Such an introduction is allowed

• if the goods meet the requirements of the Technical Regulation;

Or

• on the basis of a notification from the Ministry of Health of Ukraine for medical devices and the State Labor Service on the introduction of certain personal protective equipment in respect of which the requirements of technical regulations are not met, but the use of which is necessary in the interests of health.

In this case, the effect of these Technical Regulations does not apply to medical devices / personal protective equipment, which have been issued such a notification by the Ministry of Health of Ukraine / State Labor Service.

For putting into circulation and / or operation on the basis of the notification of the Ministry of Health of such medical devices the applicant submits to the specified body an application indicating the purpose of putting into circulation and / or operation, information on the manufacturer, product name, batch number or serial number, volume batch, purpose of the product and mode of action.

The application is also accompanied by:

• document of conformity issued outside Ukraine (if any);
• letter of confirmation of the applicant that the conformity assessment of medical devices has not been carried out.

In addition to making these changes, Resolution № 271 is designed to correct existing legal conflicts (legislative misunderstandings) and double interpretations of the legislation on VAT on medical devices.

Thus, Resolution № 271 also changes the name of the List № 224, and a number of its provisions are brought in line with COVID laws.

The List № 224 itself has been updated and expanded, in particular, computer tomographs, videoobronchoscope, portable X-ray diagnostic electrocardiograph, defibrillator and ultrasound device with a set of sensors are now included in the VAT-exempt medical devices.

To confirm the intended purpose of medical devices / personal protective equipment for the fight against COVID-19 in accordance with Resolution № 271 must be:

• a declaration of conformity is submitted and affixed to the product or its packaging, as well as to the accompanying documents, if such documents are provided by the relevant technical regulations, the mark of compliance with technical regulations in accordance with the rules and conditions of its application; or
• a notification of the Ministry of Health on the introduction into circulation and / or operation of medical devices (medical devices for in vitro diagnostics, active implantable medical devices) in respect of which the requirements of technical regulations are not met, or a notification of the State Labor Service introduction into circulation of personal protective equipment for which the requirements of technical regulations are not met.

However, in addition to the above changes, the Government has supplemented paragraph 31 of the Technical Regulation on Medical Devices, paragraph 23 of the Technical Regulation on Medical Devices for In Vitro Diagnostics, paragraph 35 of the Technical Regulation on Active Implantable Medical Devices, which gives unprecedented powers to information from the Register on the basis of an order issued in accordance with the decision.

The grounds for exclusion of information from the Register are:

• termination of the activity of the person responsible for putting products into circulation;
• non-compliance of products with the established requirements;
• providing inaccurate information to the person responsible for putting products into circulation;
• expiration of the declaration of conformity and / or certificate of conformity;
• termination or expiration of the power of attorney from the manufacturer to the authorized representative (power of attorney, contract, contract, etc.);
• a written statement of the person responsible for putting the products into circulation.

The official website of the Ministry of Health of Ukraine states that for medical devices put into circulation and / or operation on the basis of a notification from the Ministry of Health of Ukraine, it is not necessary to draw up a declaration of conformity, mark technical regulations, as well as for certain medical devices. it is not necessary to submit information to the Register of persons responsible for the introduction of medical devices into circulation.

The Ministry of Health of Ukraine notes that the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” applies to products for which the requirements of technical regulations are not met, but the use of which is necessary for the interests of health care.

The full version of the press release of the Ministry of Health of Ukraine is available at the following link https://moz.gov.ua/article/health/onovlena-informacija-schodo-timchasovih-zmin-pravil-vvezennja-medichnih-virobiv.

The European Commission’s Medical Device Coordination Group published guidance 13/05/2020 on reporting safety events involving investigational devices under the incoming regulations.

The document said sponsors will use a new template to file safety reports in the period between the Medical Device Regulation coming into force and the linked Eudamed database going live.

In a separate update this week, the EC laid out the current status of ongoing guidance development within MDCG subgroups on more than 40 topics related to MDR, IVDR, or both. Of the many deliverables slated for MDCG endorsement in 2020, two relate to Eudamed: a guidance on harmonized administrative practices and alternative technical solutions, and a position paper on the use of SRN (single registration number).