Based on the Health IT Interoperability Governance Regulation, Germany is in the process to establish a body (Competence Centre for Interoperability in Healthcare (KIG)) who shall be empowered to accredit conformity assessment bodies (CABs). The CABs shall certify information technology systems in the healthcare system.
Even if this body is not called ‘accreditation body’ in the Health IT Interoperability Governance Regulation, it shall carry out an accreditation procedure to ensure the competence of the CABs as set out in the Regulation.
The establishment of this body is violating EU law.
1. Regulation (EC) No 765/2008
Regulation (EC) No 765/2008 (in short Reg 765) lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities.
According to Article 4 (1) of Reg 765, each Member State shall appoint a single national accreditation body.
A national accreditation body is defined in Article 2 (11) of Reg 765 as the sole body in a Member State that performs accreditation with authority derived from the State.
Article 5 (1) of Reg 765 set out that a national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect.
Furthermore, Article 7 (1) of Reg 765 set out that where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established … .
Knowing, that only Reg 765 provides the legal requirements, the following documents explain the application of the law regarding the single national accreditation body:
Blue Guide 2022 (OJEU C 247), chapter 6.4.1
The Regulation foresees that each Member State may appoint one single national accreditation body. Only the national accreditation bodies are allowed to perform accreditation of conformity assessment bodies. No other bodies may claim to provide such services, be it according to harmonised standards or non-harmonised standards. This provision is central to the functioning of accreditation in the EU and to the framework of accreditation set up by the Regulation. … . This means that at no time more than one accreditation body may be active on the territory of a Member State for a given activity.
CERTIF 2013-01 REV3 Non-national accreditation bodies that claim to provide accreditation
… .
Furthermore, as Member States are responsible for the implementation of Regulation (EC) No 765/2008 on their territory and in accordance with the principle of sincere cooperation as laid down in Article 4(3) TEU, the Member States and Commission should assist each other to continuously ensure that only the officially appointed national accreditation bodies carry out accreditation of conformity assessment bodies in the Union.
2. Court of Justice of the European Union (CJEU)
The principle that only the national accreditation body is allowed to offer accreditation services to conformity assessment bodies has been confirmed by the CJEU.
The question to the Court, in essence, was whether Article 4(1) and (5) and Article 7(1) of Regulation No 765/2008 must be interpreted as precluding the interpretation of national legislation according to which accreditation may be performed by bodies other than the single national accreditation body, within the meaning of that regulation, which have their seat in a third State, where those bodies ensure compliance with international standards and demonstrate, in particular by means of mutual recognition arrangements, that they have a qualification equivalent to that of the said single accreditation body.
The Court ruled in May 2021 that Article 4(1) and (5) as well as Article 7(1) of Regulation (EC) No 765/2008 must be interpreted as precluding the interpretation of national legislation according to which accreditation may be performed by bodies other than the single national accreditation body, within the meaning of that regulation, which have their seat in a third State, even where those bodies ensure compliance with international standards and demonstrate, inter alia by means of mutual recognition arrangements, that they have a qualification equivalent to that of the said single accreditation body.
The essence of this ruling is that Reg 765 must be interpreted as precluding the interpretation of national legislation according to which accreditation may be performed by bodies other than the single national accreditation body.
That means in other words that national legislations cannot allow that accreditation may be performed by bodies other than the single national accreditation body.
3. Conclusion
The establishment of the new body in Germany, which accredit conformity assessment bodies, violates Regulation (EC) No 765/2008.
