Obligations of manufacturers of EHR systems
1. Manufacturers of EHR systems shall:
(a)
ensure that the harmonised software components of their EHR systems and the EHR systems themselves, to the extent that this Chapter establishes requirements for them, are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 36;
(b)
ensure that the harmonised software components of their EHR systems are not adversely affected by other software components of the same EHR system;
(c)
draw up the technical documentation of their EHR systems in accordance with Article 37 before placing those EHR systems on the market, and subsequently keep it up to date;
(d)
ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 38 and clear and complete instructions for use;
(e)
draw up the EU declaration of conformity in accordance with Article 39;
(f)
affix the CE marking of conformity in accordance with Article 41;
(g)
indicate the name, registered trade name or registered trade mark, the postal address, and the website, email address or other digital contact details through which they can be contacted, in the EHR system; indicate in the contact details a single point at which the manufacturer can be contacted; the contact details shall be in a language that is easily understood by users and market surveillance authorities;
(h)
comply with the registration obligations in Article 49;
(i)
take without undue delay any necessary corrective action in respect of their EHR systems, where they consider or have reason to believe that such systems are not or are no longer in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems; the manufacturers of EHR systems shall subsequently inform the national authorities of the Member States in which they made their EHR systems available on the market or put them into service of the non-conformity, of any corrective action taken, including the timetable for implementation, and of the date at which the harmonised software components of their EHR systems have been brought into conformity or been recalled or withdrawn;
(j)
inform the distributors of their EHR systems and, where applicable, the authorised representative, importers and users of the non-conformity and of any corrective action, recall or withdrawal of those EHR systems;
(k)
inform the distributors of their EHR systems and, where applicable, the authorised representative, importers and users of any mandatory preventive maintenance of the EHR systems and its frequency;
(l)
upon request, provide, in an official language of the Member State concerned, market surveillance authorities in that Member State with all the information and documentation necessary to demonstrate the conformity of the EHR systems which they have placed on the market or put into service with the essential requirements laid down in Annex II;
(m)
cooperate with market surveillance authorities, at their request, on any action taken to bring the EHR systems which they have placed on the market or put into service into conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 in an official language of the Member State concerned;
(n)
establish channels of complaint and keep distributors informed thereof;
(o)
keep a register of complaints and a register of non-conforming EHR systems and keep distributors informed thereof.
2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of the harmonised software components of an EHR system continue to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 36. Changes in EHR system design or characteristics with regard to the harmonised software components of an EHR system shall be adequately taken into account and reflected in the technical documentation.
3. Manufacturers of EHR systems shall keep the technical documentation referred to in Article 37 and the EU declaration of conformity referred to in Article 39 for 10 years after the EHR system covered by the EU declaration of conformity has been placed on the market.
Manufacturers of EHR systems shall make available the source code or the programming logic included in the technical documentation, upon a reasoned request, to the relevant authorities, if that source code or programming logic is necessary in order for those authorities to be able to check compliance with the essential requirements laid down in Annex II.
4. A manufacturer of EHR systems established outside the Union shall ensure that its authorised representative has the necessary documentation readily available in order to fulfil the tasks referred to in Article 31(2).
5. Manufacturers of EHR systems shall, upon a reasoned request from a market surveillance authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements laid down in Annex II and the common specifications referred to in Article 36, in a language which can be easily understood by that market surveillance authority. The manufacturers of EHR systems shall cooperate with the market surveillance authority, at its request, on any measures taken to eliminate the risks posed by an EHR system which they have placed on the market or put into service.
Authorised representatives
1. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.
2. An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a)
keep the EU declaration of conformity and the technical documentation referred to in Article 37 at the disposal of market surveillance authorities for the period referred to in Article 30(3);
(b)
further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;
(c)
inform without undue delay the manufacturer if the authorised representative has reason to believe that an EHR system is no longer in conformity with the essential requirements laid down in Annex II;
(d)
inform without undue delay the manufacturer about any complaint received from consumers or professional users;
(e)
cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate;
(f)
terminate the mandate if the manufacturer does not comply with its obligations under this Regulation;
(g)
ensure that the technical documentation referred to in Article 37 can be made available to relevant authorities, upon request.
3. In the event of a change of the authorised representative, the detailed arrangements for such change shall address at least the following:
(a)
the date of termination of the mandate of the outgoing authorised representative and the date of the beginning of the mandate of the incoming authorised representative;
(b)
the transfer of documents, including confidentiality aspects and property rights.
4. Where the manufacturer is established outside the Union and has not complied with the obligations laid down in Article 30, the authorised representative shall be jointly and severally liable for non-compliance with this Regulation on the same basis as the manufacturer.
Obligations of importers
1. Importers shall place on the Union market only EHR systems which are in conformity with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36.
2. Before making an EHR system available on the market, importers shall ensure that:
(a)
the manufacturer has drawn up the technical documentation referred to in Article 37 and the EU declaration of conformity;
(b)
the manufacturer is identified and an authorised representative has been appointed in accordance with Article 31;
(c)
the EHR system bears the CE marking of conformity referred to in Article 41 after the conformity assessment procedure has been completed;
(d)
the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use, including for its maintenance, in accessible formats.
3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address, website, email address or other digital contact details through which they can be contacted in a document accompanying the EHR system. The contact details shall indicate a single point at which the manufacturer can be contacted and shall be in a language which can be easily understood by users and market surveillance authorities. Importers shall ensure that any additional label does not conceal or obscure any of the information provided by the manufacturer that appears on any original label which is provided for the EHR system.
4. Importers shall ensure that, while an EHR system is under their responsibility, the EHR system is not altered in such a way that its conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 is jeopardised.
5. Where an importer considers or has reason to believe that an EHR system is not or is no longer in conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42, it shall not make that EHR system available on the market, or, if that EHR system was already placed on the market, shall recall or withdraw it, until the EHR system has been brought into conformity. In the event of such recall or withdrawal, the importer shall inform without undue delay the manufacturer of such EHR system, the users and the market surveillance authorities of the Member State in which it made the EHR system available on the market of such recall or withdrawal, giving details, in particular, of the non-conformity and of any corrective measures taken.
Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons, it shall without undue delay inform the market surveillance authorities of the Member State in which it is established, as well as the manufacturer and, where applicable, the authorised representative.
6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 30(3) and ensure that the technical documentation referred to in Article 37 can be made available to those authorities, upon request.
7. Importers shall, further to a reasoned request from market surveillance authorities of the Member States concerned, provide them with all the information and documentation necessary to demonstrate the conformity of an EHR system. Importers shall cooperate with those authorities, at their request, and with the manufacturer and, where applicable, with the authorised representative in an official language of the Member State where the market surveillance authority is located. Importers shall cooperate with those authorities, at their request, on any action taken to bring their EHR systems into conformity with the essential requirements in relation to the harmonised software components as laid down in Annex II or to ensure that the EHR systems which are not in conformity with those essential requirements are recalled or withdrawn.
8. Importers shall establish reporting channels and ensure that they are accessible to allow users to submit complaints, and shall keep a register of complaints, of non-conforming EHR systems and EHR system recalls and withdrawals. Importers shall verify whether the channels of complaint established pursuant to Article 30(1), point (n), are publicly available, allowing users to submit complaints and to receive any communication concerning any risk related to their health and safety or to other aspects of public interest protection and allowing users to be informed of any serious incident involving an EHR system. Where such channels of complaint were not established, the importers shall establish them and take into account the accessibility needs of vulnerable groups and persons with disabilities.
9. Importers shall investigate complaints and follow up on information received on incidents involving an EHR system they made available on the market. Importers shall register those complaints, any recalls or withdrawals of EHR systems and any corrective measure taken to bring the EHR system into conformity, in the register referred to in Article 30(1), point (o), or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation and follow-up carried out and of the results of the investigation and follow-up.
Obligations of distributors
1. Before making an EHR system available on the market, distributors shall verify that:
(a)
the manufacturer has drawn up the EU declaration of conformity;
(b)
the EHR system bears the CE marking of conformity;
(c)
the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use in accessible formats;
(d)
where applicable, the importer has complied with the requirements set out in Article 32(3).
2. Distributors shall ensure that, while an EHR system is under their responsibility, the EHR system is not altered in such a way that its conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 is jeopardised.
3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42, it shall not make that EHR system available on the market until it has been brought into conformity. The distributor shall inform without undue delay the manufacturer or the importer, as well as the market surveillance authorities of the Member States where the EHR system has been or is to be made available on the market, to that effect. Where a distributor considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons, it shall inform the market surveillance authorities of the Member State in which the distributor is established, as well as the manufacturer and the importer.
4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring an EHR system into conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 or to recall or withdraw it.
Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
An importer, distributor or user shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 30 where they:
(a)
make an EHR system available on the market under their own name or trademark;
(b)
modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
(c)
modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years from the date when the last EHR system covered by the EU declaration of conformity has been placed on the market:
(a)
any economic operator that has supplied them with an EHR system; and
(b)
any economic operator to which they have supplied an EHR system.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
