Article 30
Obligations of manufacturers of EHR systems
In short: Manufacturers of EHR systems shall conform to the EHR requirements, and publish technical documentation.
- 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conformity or been recalled or withdrawn;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.
- 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.
- 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.
- 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).
- 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.
Discussion
From the EU FAQ: As a manufacturer of EHR systems, what steps do I have to take before I can place EHR
systems on the market?
You will have to make sure that your EHR system complies with the requirements of the EHDS Regulation:
- Make sure that it provides the capabilities of the two harmonised components.
To be placed on the market or put into service in the Union, EHR systems must contain the two
harmonised software components, namely: the interoperability component and the logging component.
These 'components' describe capabilities of EHR systems. (Annex II, Article 36);
- Prove that it does so by passing the tests in the automated testing environment (covered by Article 40.
The automated testing environments will test the two harmonised components of your EHR systems against the requirements in the EHDS Regulation.
You will have to do these tests before placing your systems on the market in the Union. You will receive a
test report that will become part of your system documentation.;
- Draw up the technical documentation required under Article 37 and provide the information
sheet required under Article 38;
- Draw up the EU declaration of conformity in accordance with Article 39;
- Affix the CE marking in accordance with Article 41;
- Register your system in the Article 49 database
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About Ringholm bv
Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT.
We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.
