On 25 May 2017, the EU regulations 2017/745 for medical devices (MDR) and 2017/746 for in-vitro diagnostics (IVDR) came into force. Currently, the MDR still has a three-year transitional period until 26 May 2020 and the IVDR a five-year transitional period until 26 May 2022. During this period, the MDR and IVDR and the previous directives MDD (medical devices), AIMD (active implants) and IVDD (in vitro diagnostics) apply concurrently. But still, many things need to be resolved and current processes must be adapted to the new MDR and IVDR requirements. This mainly affects manufacturers of medical devices. However, the authorities and institutions still have one significant aspect to solve, namely the harmonised standards.
What are harmonised standards and why do we need them?
So-called Harmonised Standards are used to establish or claim conformity with the Essential Requirements of Annex I of the MDD. This procedure is also referred to as presumption of conformity. Harmonised standards are usually ISO or IEC standards, but sometimes (and more frequently in the past) purely European standards. These are standardised on behalf of the European Commission and EFTA, and explicitly published in the EU Official Journal. Therefore, these standards are uniform throughout Europe. In order to obtain the status of “harmonisation”, the general standards must also be provided with additional so-called "Zx Annexes". These annexes state - mostly in tabular form - whether the standard is suitable or which chapter or paragraph of the standard is suitable to cover the essential requirement(s) of the corresponding annexes of the Medical Devices Directive 93/42/EEC, the Active Implant Directive 90/385/EEC and the In-Vitro-Diagnostic Medical Devices Directive 98/79/EC. In short, all harmonised standards which are used should cover the Essential Requirements. If gaps still remain, they must be filled with other verifications.
Now such a harmonisation is missing for the MDR so far, but in June 2019 the EU Commission published a list of standards that are planed to be harmonised. The mandate to draw up this list has already been given and now the individual standardisation bodies must do their work. The bodies must determine how certain regulatory requirements are to be met by corresponding chapters or parts (individual sentences) of one respective standard. This is then recorded in annex Zx.
Although the harmonisation has not yet been completed and only planned standards have been announced so far, medical device manufacturers should already think about how they will establish conformity to the General Safety and Performance Requirements of the new European regulations.
It can be assumed that the European medical device standards, which have already been harmonised under the MDD, are also suitable for demonstrating conformity with most of the Essential Safety and Performance Requirements of the new regulations. These standards have proved their worth in assessing conformity with the Essential Requirements. Therefore, this conclusion is natural and is also confirmed by the Commission's list, with many new standards being added to the current ones.
Amongst others, this includes the following European standards:
- EN 556: Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1-2
- EN 10993: Biological evaluation of medical devices, part 1-18
- EN ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- EN ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice
- EN ISO 14971: Medical Devices – Application of Risk Management to Medical Devices
- EN ISO 15223-1: Medical Devices – Symbols to Be Used with Medical Device Labels, Labelling and Information to Be Supplied - Part 1: General Requirements
- EN 60601-1: Medical Electrical Equipment, General Requirements
- EN 62304: Medical Device Software – Software Life Cycle Processes
- EN 62366-1: Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
Practical guides for determining conformity
In a company, quality management representatives or quality and regulatory affairs managers usually come into contact with the proof of compliance of the products in terms of the general safety and performance requirements of the MDR or IVDR.
It can be assumed that the relevant standards can also be used under the new regulations to prove conformity, for under the old directives their conformity with the General Requirements was demonstrated. These standards will soon be harmonised under the new EU regulations.
Harmonisation of specific standards for products cannot be expected in all cases. In individual cases, it would be necessary to check whether the specific standard will be harmonised or not. A reference to the corresponding requirement in the MDD is helpful here. In case of doubt, the Notified Body can be consulted.
In the case of European guidelines, which explicitly refer to requirements specified in the MDR, proof of compliance has actually already been provided per se. Of course, this also applies to corresponding national laws which implement the regulations and directives.
Since most of the guidelines and directories of the European Union have been adapted to the old directives, they should only be used with caution. One exception is the MEDDEV 2.7/1 rev. 4, parts of which have been incorporated into the text of the MDR. If guidelines are mentioned in the requirement text of the MDR, they can of course be used as proof.
Further development will show, whether harmonisation will also apply to specific standards for certain medical devices or product groups. Furthermore, the European Commission has given the possibility of demonstrating conformity with the General Safety and Performance Requirements in the area for which there are no harmonised standards by means of compliance with so-called "common specifications" (Art. 9 MDR). Meaning, in future, there will be in addition to the harmonised standards another instrument for proof of conformity.
Until then, i.e. before standards are finally harmonised under the MDR and the first common specifications are drawn up, time will pass. In case of doubt, it is definitely a step in the right direction to agree on a joint approach with the Notified Bodies.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.