'"common specifications' [..] means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system."
EU Directives, such as the MDD and IVDD, as well as EU Regulations, such as the MDR and IVDR impose so-called general requirements on all medical device must meet. If the requirements are not met, manufactures must not place them on the market.
When conducting an audit or assessing the technical documentation, it should be possible to easily determine if these requirements are actually met. Therefore, clear decision criteria are helpful.
Standards contain such specific criteria. EU Regulations and Directives allow manufacturers to make use of harmonized standards for evidence. Where harmonized standards do not exist or are insufficient, specific criteria are lacking. It is these deficiencies that Common Specifications shall overcome.
The Commission may even lay down Common Specifications if "there is a need to address public health concerns" - ambiguous meaning.
The EU Commission perceives itself to be entitled to implement common technical specifications where no harmonized standards exist or where they are not sufficient.
Article 105 defines the tasks of the Medical Device Coordination Group (MDCG). One task, amongst others, is to contribute to the development of standards, common specifications and of scientific guidelines, including product specific guidelines.
Article 106 adds that expert panels and expert laboratories contribute to formulating and refining appropriate guidelines and common standards.
The MDR's preface says: "Common specifications ('CS') should be developed after consulting the relevant stakeholders and taking account of European and international standards."
The EU Commission entitles itself to define Common Specifications for the following regulatory areas:
The following topics are especially touched on:
The Commission keeps all its options open. According to Article 9, it can but doesn't need to lay down common specifications.
During audits and assessment of technical documentation, notified bodies must review compliance with common specifications even if the manufacturer does not reference them. This is laid down in Annex VII "4.5. Conformity assessment activities"The same applies to type-examinations.
It is not quite accurate to say that Common Specifications were introduced for the first time by the MDR and IVDR. In fact, Directive 98/79/EC already mentioned these Common Specifications. The IVDD lays down in Article 5 "Reference to standards" that conformity with general requirements is to be presumed if harmonized standards or these very common specifications are complied with.
With this concept, the EU Commission has given itself almost full discretion to strengthen requirements for medical devices. Thereby, it can put tremendous pressure on standardization bodies or bypass them if they don't act according to the Commission's will.
Neither the parliamentary nor the consensus building of international standardization bodies can limit the Commission's freedom. Expert panels and the Medical Device Coordination Group must only be heard and must cooperate. They are not competent to give a ruling.
It remains a mystery why the Commission believes to be more suited to define specifications than standardization bodies. Rule 11 may be an example for showing that there is nobody in their ranks who has ever developed and placed a medical device on the market themselves.
Once again, the impression is imposed that, under the guise of patient safety, requirements are raised to an extend that future products serving patients' health will be lacking.